Donate to RSDSA – a single gift can help so many & support better treatments


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I alone cannot change the world, but I can cast a stone across the waters to create many ripples.
– Mother Teresa
Donations are like a stone in the water, a single gift can ripple through the community to help many people. Every donation to us is terrific and we want you to know that each is important and meaningful.
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The holiday season is a special time of the year for being part of a community, sharing, receiving and giving. We ask you to make a gift to our End of the Year appeal to ease the lives of people with CRPS.
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We can’t make the pain go away, but with a donation from you we can work together to give those with CRPS support, education, and hope while driving research to develop better treatments and a cure.
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Consider the impact your donation will make in 2020 on the lives of those with CRPS. We can work together and share the goal of bringing light and hope to people living with CRPS.
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Thank You!

The RSDSA Staff – Pam Kientzler, Jim Broatch, Jennifer Pincus & Tracy Greer

Courageous Kids Camp Open for Applications!

Courageous Kids Camp instills inspiration and empowerment in children!
Registration for the 2020 camp and retreat sessions is now open. Apply today.

Bad Flare Day Shirts Are Now Available!

These “Bad Flare Day” shirts were a hit at the 4th Annual RSDSA Long Island CRPS Awareness Walk & Expo in September!
Head over the RSDSA Shop to purchase your shirt today just in time for the holidays!

Thank you to our title sponsors!
Our title sponsors make RSDSA events and awareness activities possible. Please join us in thanking and supporting them!
The Michael and Elizabeth Axelrod Family Foundation

RSDSA
99 Cherry St. • P.O. Box 502 • Milford, CT 06460
Tel: 203.877.3790 • Toll Free: 877.662.7737

Our Mission
Reflex Sympathetic Dystrophy Syndrome Association (RSDSA) mission is to provide support, education, and hope to all affected by the pain and disability of CRPS/RSD, while we drive research to develop better treatments and a cure.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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PLEASE GIVE TO RSDSA – donor will match donations up to $5,000!


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Neuropathic Pain is

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highly difficult to treat 

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and few medications are available

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Please donate to RSDSA to support research for neuropathic pain & help those disabled by pain.

 

 

From RSDSA:

 

It’s almost go time!

 

We are only days away from #GivingTuesday 2019! This year, we have a donor who will match our donations up to $5,000! It’s true that it takes a village like our community to work together and raise awareness, educate, and advocate for better treatments.

 

If you haven’t done so already, please make a donation to our #GivingTuesday fundraising page and tell your friends and family about our campaign. Spreading the word gets our voices heard and the donations rolling in! We’re excited to be a part of this worldwide event and providing a chance to give back to our community.

 

Please join our campaign between now

 and Tuesday, December 3, 2019

 

RSDSA’s 2019 Accomplishments

 

  • Co-sponsorship of Courageous Kids Camp for children with CRPS in Kentucky for the 4th year

  • Sponsorship of Young Adults Weekends for young adults with CRPS who are transitioning into the workforce, independent living, and other new situations

  • Sponsorship of an accredited free online course on pediatric CRPS

  • Sponsorship of two Treating the Whole Person conferences; in Houston and Denver

  • And much more!

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Cheers,

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Your Team at RSDSA

 

 

 

 

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We are highlighting a different Warrior’s story on our blog each day!

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Catch up on the posts today!

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Low Dose Naltrexone for Pain


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From NPR: 

In Tiny Doses, An Addiction Medication Moonlights As A Treatment For Chronic Pain

 

Alex Smith

 

Lori Pinkley, a 50-year-old from Kansas City, Mo., has struggled with puzzling chronic pain since she was 15.

 

She’s had endless disappointing visits with doctors. Some said they couldn’t help her. Others diagnosed her with everything from fibromyalgia to lipedema to the rare Ehlers-Danlos syndrome.

 

Pinkley has taken opioids a few times after surgeries but says they never helped her underlying pain.

 

“I hate opioids with a passion,” Pinkley says. “An absolute passion.”

 

Recently, she joined a growing group of patients using an outside-the-box remedy: naltrexone. It is usually used to treat addiction, in a pill form for alcohol and as a pill or a monthly shot for opioids.

 

As the medical establishment tries to do a huge U-turn after two disastrous decades of pushing long-term opioid use for chronic pain, scientists have been struggling to develop safe, effective alternatives.

 

When naltrexone is used to treat addiction in pill form, it’s prescribed at 50 mg, but chronic-pain patients say it helps their pain at doses of less than a tenth of that.

 

Low-dose naltrexone has lurked for years on the fringes of medicine, but its zealous advocates worry that it may be stuck there. Naltrexone, which can be produced generically, is not even manufactured at the low doses that seem to be best for pain patients.

 

Instead, patients go to compounding pharmacies or resort to DIY methods — YouTube videos and online support groups show people how to turn 50 mg pills into a low liquid dose.

 

Some doctors prescribe it off-label even though it’s not FDA-approved for pain.

 

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For discussion of mechanism and case reports of the remarkable efficacy of this anti-inflammatory medication, use search function top left above small photo. Thankfully his insurer is covering the cost of the compounded capsules.

 
 
 
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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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Please DONATE to RSDSA to Help Patients & Research on Neuropathic Pain






Neuropathic Pain is highly difficult to treat and few medications are available.

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Please donate to RSDSA to support research for neuropathic pain & help those disabled by pain.

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WE CAN NOT DO IT ALONE 

During this holiday season of thankfulness and giving, RSDSA appreciates your commitment to making an impact on the lives of those who struggle with Complex Regional Pain Syndrome (CRPS). Your financial support and kindness have enabled RSDSA to help many individuals with CRPS. This excruciatingly painful and debilitating disorder does not discriminate; it affects the lives of children, teenagers and adults 24 hours a day, 7 days a week. Sadly, each year, 50,000 new cases of CRPS are diagnosed.  We at RSDSA must be prepared to meet their needs. 

BUT WE CAN NOT DO IT ALONE

For more than 34 years, our commitment to provide support, education and hope to all affected by the pain and disability of CRPS remains strong.  We are still determined to drive research to develop better treatments and hopefully a cure.    

Because of your Generosity, in 2018 we:

Co-sponsored 250 children with CRPS (and other pain syndromes) and their families at The Center for Courageous Kids Camp.  The experience allowed the campers to feel like kids again for the first time since the onset of their illness. This is our 4th year.  Wheelchairs welcome!Sponsored Young Adult retreats in Austin, TX and Nashville, TN for 25 young adults (aged 18-25). Many had never met anyone who had CRPS.  

Friendships, ongoing networking and a young adult committee have since developed,Sponsored conferences in San Jose, CA and Charlotte, NC attended by 400 individuals with CRPS, caregivers, and medical professionals; 14 new educational videos were added to our YouTube channel.  

362 individuals with CRPS received emergency funding to pay for heat and other utilities, rent, durable medical equipment, travel expenses to obtain medical care and more, Created a new Advocacy Committee which will explore and promote the interests of the CRPS community. It will create awareness, encourage increased clinical and research funding, and promote changes in the CDC Guidelines, Answered more than 5000 emails and phone calls which poured into our office.

Our compassionate staff answered questions, provided information packets and a list of knowledgeable health professionals who understand and treat CRPS, Mailed 17,725 newsletters to individuals with CRPS, health professionals and caregivers three times a year. The newsletters, filled with the latest updates and inspiring personal stories, were also sent electronically 3 times a year to our online community.

Please make a donation Now! 

Thank you for your kind consideration. 


RSDSA Staff – Sincerely yours,


James Broatch, Tracy Geer, Pamela Kientzler, Jennifer Pincus, 
Endra Newell, Alyce LoweJim, Tracy, Pam, Jennifer, Endra, Alyce







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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators Can Cause Deaths & Injuries


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Washington Post Reports .

Injuries & Deaths from.

Spinal Cord Stimulators

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Excerpts below are from the November 25 report linked above on spinal cord stimulators. Use search function top left for prior several posts on this site:

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…one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.

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But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.

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Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.

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The FDA data contains more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.

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Medical device manufacturers insist spinal-cord stimulators are safe — some 60,000 are implanted annually — and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients.

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Most of these devices have been approved by the FDA with little clinical testing, however, and the agency’s data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.

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The AP reported on spinal stimulators as part of a nearly yearlong joint investigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.

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The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.

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The investigation also found that the FDA — considered by other countries to be the gold standard in medical device oversight — puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.

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Devices are rarely pulled from the market, even when major problems emerge. And the FDA does not disclose how many devices are implanted in the U.S. each year — critical information that could be used to calculate success and failure rates….

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…The four biggest makers of spinal-cord stimulators are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, with headquarters in Ireland and the U.S.; Nevro, in Redwood City, California; and Illinois-based Abbott, which entered the market after its $23.6 billion purchase of St Jude Medical Inc.

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St. Jude’s application to go to market with its first spinal stimulator contained no original patient data and was based on clinical results from other studies, while Boston Scientific’s application for its Precision spinal-cord stimulator was based largely on older data, though it did include a small, original study of 26 patients who were tracked for as little as two weeks.

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Once approved, medical device companies can use countless supplementary requests to alter their products, even when the changes are substantial.

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For example, there have been only six new spinal-cord stimulator devices approved since 1984, with 835 supplemental changes to those devices given the go-ahead through the middle of this year, the AP found. Medtronic alone has been granted 394 supplemental changes to its stimulator since 1984, covering everything from altering the sterilization process to updating the design.

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“It’s kind of the story of FDA’s regulation of devices, where they’re just putting stuff on the market,” said Diana Zuckerman, president of the National Center for Health Research, who has studied medical devices for nearly 30 years.

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….“These patients are guinea pigs,” she said.

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….Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, said trials for medical devices like spinal-cord stimulators are generally small and industry-sponsored, with a “substantial” placebo effect.

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“I don’t know of anyone who is happy with spinal-cord technology as it stands,” Koroshetz said. “I think everybody thinks it can be better.”

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….[Jim] Taft’s stimulator failed soon after it was surgically implanted. After an operation to repair it, he said, the device shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. Today, the 45-year-old Taft is virtually paralyzed, a prisoner in his own bed, barely able to get to the bathroom by himself…..

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Taft said his three-day trial helped reduce his pain so, a few days before his surgery, he began preparing for a new life. He ordered lumber to refurbish a patio and deck for his wife, Renee, as thanks for her years of support.

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In April 2014, Boston Scientific’s Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. A Boston Scientific sales representative was in the operating room — a common practice, the AP found.

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Highsmith would not comment on the payments. Other doctors have defended the practice, saying they do important work that helps the companies — and ultimately patients — and deserve to be compensated for their time.

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From the time Taft was cut open and the device placed inside his body, he had nothing but problems, according to hundreds of pages of medical records reviewed by the AP. The device began randomly shocking him, and the battery burned his skin.

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Taft and his wife complained repeatedly, but said his doctors and a Boston Scientific representative told them that spinal-cord stimulators don’t cause the kind of problems he had.

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That runs counter to Boston Scientific’s own literature, which acknowledges that spinal stimulators and the procedures to implant them carry risks, such as the leads moving, overstimulation, paralysis and infections.

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That also is not reflected in the AP’s analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal-cord stimulators. For Boston Scientific devices, infection was the most common complaint over the past decade, mentioned in more than 4,000 injury reports.

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In response to questions, the company called infection “unfortunately a risk in any surgical procedure” that the company works hard to avoid. It added that the FDA’s data “shouldn’t be interpreted as a causal sign of a challenge with our device. In fact, many examples of reportable infections include those that were caused by the surgical procedure or post-operative care.”

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“In our internal quality assessments, over 95 percent of the injury reports were temporary or reversible in nature,” the company added.

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Taft said had he known the devices hurt so many people, he would have reconsidered getting one. A Boston Scientific sales representative tried reprogramming the device, he said, but nothing worked.

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“I told them that it feels like the lead is moving up and down my spine,” Taft said. “They said, ‘It can’t move.’” But in July 2014, X-rays revealed the lead indeed had moved — two inches on one side.

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Highsmith told the AP the electrode broke from “vigorous activity,” though Taft said that would not have been possible due to his condition. Taft said he was in such bad shape after his surgery that he was never able to redo the patio and deck for his wife or do anything else vigorous.

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That October, Highsmith said, he operated on Taft to install a new lead, tested the battery and reinserted it.

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Still, Taft’s medical records show that he continued to report numbness, tingling and pain. During a January 2015 appointment, a physician assistant wrote that the device “seemed to make his pain worse.”

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The stimulator was surgically removed in August 2015. The following June, Taft got a second opinion from a clinic that specializes in spinal injuries, which said he had “significant axial and low back pain due to implantation and explantation” of the stimulator.

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Highsmith said other doctors have documented severe arthritis in Taft and that, while he has not examined Taft in more than three years, it’s “likely his current condition is the result of disease progression and other factors.”

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He did not answer questions about whether he informed Taft of the risks associated with stimulators.

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The doctor said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief.

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“Unfortunately, in spite of the major medical breakthroughs with devices like these, some patients still suffer from intractable pain,” he said.

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Renee Taft, a paralegal, reached out to Boston Scientific in 2017, but said the company refused to help because her husband’s stimulator had been removed and blamed Taft for his problems, also saying he had engaged in “rigorous physical activity” after surgery.

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In the letter from the company’s legal department, Boston Scientific also noted that federal law shielded manufacturers from personal liability claims involving medical devices approved by the FDA.

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In response to questions from the AP, Boston Scientific again blamed Taft’s “activity level” but didn’t elaborate. The company also said other factors could contribute to his problems such as “hyperalgesia, a phenomenon associated with long-term opioid use which results in patients becoming increasingly sensitive to some stimuli.”

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Brenda Simpson-Davis of Milton, Florida, said Boston Scientific also disregarded her complaints after her husband suffered a life-threatening infection following implant surgery.

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George Davis, 57, had three Medtronic spinal-cord implants between 2003 and 2007 after a car accident mangled his back. They temporarily reduced some of his pain, but he said the non-rechargeable batteries that were supposed to last for years never did and he tired of multiple surgical removals.

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In 2015, his pain management doctor urged him to try Boston Scientific’s Precision Spectra, which he called the best on the market. Unlike Davis’s old models, it had a rechargeable battery.

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Within weeks of his surgery, Davis said, he started feeling pain shooting down his back and legs and a burning sensation at the implant site. After his skin started turning black, the doctor performed emergency surgery to remove the device.

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Months later, Davis reluctantly agreed when his doctor urged him to try another Boston Scientific model but found that device even worse.

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Over the next year, he spent more than 100 days in and out of hospitals battling a life-threatening infection. Today, Davis says he has trouble getting out of bed.

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Boston Scientific said it never received the stimulators that were implanted in Taft and Davis so could not “conclusively identify” the causes of their problems. “Numerous factors can contribute to a patient’s ongoing symptoms, from increased physical activity to the onset of pain in other areas,” the company said.

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Simpson-Davis said she spoke with attorneys around the country, who warned her about the high bar set for a lawsuit . Finally, she found a Texas lawyer who said he will consider taking the case if she can find another two dozen potential plaintiffs.

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“To me, it’s not about the money, It’s about the people. It’s about them knowing what they’re getting themselves into,” she said.

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For years, Valerie McJunkin had been seeking relief from a rare neurological disorder that made her legs and feet feel like they were on fire. So when a medical device company sales representative and her West Virginia pain management doctor recommended what sounded to her like a “miracle device,” she was all in.

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They said a new kind of stimulator — one that targeted a bundle of sensory nerve cells in the lower back — was better than a spinal-cord device. She just needed to undergo a weeklong trial.

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When McJunkin showed up at the pain clinic this January for the trial, the Abbott sales representative was there, along with her doctor and his staff. They explained every detail. This device wasn’t for everyone, but she was the perfect candidate, she recalled them saying.

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Over the next week, they called or texted her nearly every day to see if the stimulator was easing her torment. And since the trial did seem to help, she went ahead with the implant.

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Within days, though, the device began randomly shocking her — a sharp pain that felt like a lightning bolt.

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When McJunkin called her doctor and the Abbott representative, she said they suggested that she was at fault because “stimulators don’t do that.” It wasn’t until she received a certified letter from Abbott in March that she learned it wasn’t all in her head: The company said her device was being recalled due to a glitch that could cause patients some “discomfort.”

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Since 2005, there have been 50 recalls involving spinal stimulators, averaging about four per year in the last five years. Roughly half the recalls involved stimulators made by Medtronic, the world’s largest device manufacturer, though none warned of a risk of serious injury or death.

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In early September, McJunkin invited an AP reporter to accompany her when she met with her doctor and the company sales representative to request the device be removed.

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The Abbott salesman and her doctor both suggested she get another stimulator, saying she had run out of options, especially since her doctor couldn’t write prescriptions for opioids because of a government crackdown. If she didn’t get another stimulator, he said, she faced a lifetime of pain. He did not suggest other options, such as steroid shots or continued physical therapy.

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“I’m not trying to force your mind,” the doctor said. “But for me, would I want to live my life like this?… If I get that new battery and it totally helps, that changes my life 180 degrees, right? But if I don’t I already know what’s going to happen to me: I’ll be suffering for the rest of my life.”

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On the drive home to Martinsburg, West Virginia, McJunkin gripped the steering wheel of her car, her tattoo reading “persevere” visible on her forearm.

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“You trust your doctor. You think he’s going to do the right thing,” she said. She paused, fighting back tears. “I just wanted to live without pain. But now that hope is gone.”

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In late October, her doctor removed the device.

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The experience of nearly all the 40 patients interviewed by the AP mirrored McJunkin’s: Their pain was reduced during the trial but returned once their stimulators were implanted.

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Experts say the answer may be a placebo effect created when expectations are built up during the trial that only the stimulator can offer relief from pain, exacerbated by patients not wanting to disappoint family members, who often have been serving as their caregivers.

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“If patients know this is a last resort, a last hope, of course they will respond well,” said Dr. Michael Gofeld, a Toronto-based anesthesiologist and pain management specialist who has studied and implanted spinal-cord stimulators in both the U.S. and Canada.

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By the time the trial ends, the patient is “flying high, the endorphin levels are high,” Gofeld said.

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Manufacturer representatives are heavily involved during the entire process. Along with often being in the operating room during surgery in case the physician has questions, they meet with patients to program the devices in the weeks following surgery.

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Most of the patients interviewed by the AP said the adjustments to their devices were performed by sales representatives, often with no doctor or nurse present. That includes one patient who was billed for programming as if the doctor was in the room, though he was not.

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“People who are selling the device should not be in charge of maintenance,” Gofeld said. “It’s totally unethical.”

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In a 2015 Texas case, a former Medtronic sales representative filed suit contending she was fired after complaining that the company trained employees to program neurostimulators without physicians present. She also claimed that a Medtronic supervisor snatched surgical gloves away from her when she refused to bandage a patient during a procedure, pushed her aside and then cleaned and dressed the patient’s wound. Medtronic denied the allegations, and the case was settled on undisclosed terms.

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In the Justice Department case involving Medtronic, a salesman who said he earned as much as $600,000 a year selling spinal-cord stimulators claimed sales representatives encouraged physicians to perform unnecessary procedures that drove up the costs for Medicare and other federal health programs.

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“While there have been a few instances where individuals or affiliates did not comply with Medtronic’s policies, we acted to remedy the situation in each case once discovered and to correct any misconduct,” the company said.

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Gofeld said he believes stimulators do work, but that many of the problems usually arise when doctors don’t choose appropriate candidates. And he thinks the stimulators are used too often in the U.S.

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Nevro, one of the four big manufacturers, has cited estimates that there are as many as 4,400 facilities in the U.S where spinal-stimulation devices are implanted by a variety of physicians, including neurosurgeons, psychiatrists and pain specialists.

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It’s a lucrative business . Analysts say stimulators and the surgery to implant them costs between $32,000 and $50,000, with the device itself constituting $20,000 to $25,000 of that amount. If surgery is performed in a hospital, the patient usually stays overnight, and the hospital charges a facility fee for obtaining the device. Costs are typically covered by insurance.

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The AP found that doctors can make more money if they perform the surgery at physician-owned outpatient surgery centers, since the doctor buys the device, marks it up and adds on the facility fee.

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In Canada, where Gofeld now works, he said the surgeries are done only by those who specialize in the procedures. He said spinal-cord stimulators should be used when pain starts and not after failed back surgeries.

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“By then,” he said, “it’s too late.”

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While manufacturers and top FDA officials tout stimulators as a weapon in the battle against opioids, neurosurgeons like Steven Falowski are the front-line evangelists.

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“Chronic pain is one of the largest health-care burdens we have in the U.S. It’s more than heart disease, cancer and diabetes combined,” Falowski said in an interview.

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He referred AP to Corby, as one of his surgical patients who was helped by a spinal-cord stimulator.

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Corby got the device more than two years ago and says that, after some initial adjustments, he hasn’t had any further problems. He says he wouldn’t trade the stimulator for opioids.

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“I was actually buying them on the street … a little like a druggie because I couldn’t get them anymore” from his pain doctor, Corby said.

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Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that’s where spinal-cord stimulators come in.

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If they’re used early enough for pain, they can prevent people from going on opium-based pain killers, said Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.

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Since 2013, device manufacturers have paid Falowski — or St. Luke’s University Health Network in Fountain Hill, Pennsylvania, where he works — nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.

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.….Another of Falowski’s patients was Lisa Snyder of Kempton, Pennsylvania, who was searching for relief from a painful nerve disorder. By the time she came to Falowski, she had cycled through three spinal-cord stimulators, which were removed for reasons ranging from infection to rejection.

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“Not everybody could do it, but he was confident he could,” she said.

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After her fourth implant this March, “I complained about this battery right away. I knew it was positioned funny. It burned,” Snyder said.

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AP’s analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words “heat” or “burn.”

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Abbott said that many of the “adverse events” reports in the FDA’s data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site “is often a reality for rechargeable spinal-cord stimulation systems,” which is why the company is now concentrating on devices that do not need to be recharged.

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….Snyder said she felt like Falowski’s nurse and physician assistant downplayed the problems and that the reprogramming of her device was conducted by the Abbott sales representative, with no medical staff present. On at least one occasion, she was charged as if the medical staff was there, when she said they weren’t, according to insurance bills reviewed by the AP.

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.Despite insisting nothing was wrong with the unit, Snyder said, Falowski called her one day out of the blue. “He said ‘Under no circumstances are you to turn it on.’ I asked him why and he wouldn’t say,” Snyder recalled..Falowski then scheduled immediate surgery to remove the stimulator, she said..Falowski called Snyder a difficult patient and said she was receiving “100 percent pain relief” when she had the stimulator removed, adding that she “remained very appreciative of her care.” He added that programming is “performed under the direction of a physician.”.“The physician is not present during the entire programming session, but provides oversight and direction..

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…The only time programming sessions are billed is when the physician is actively seeing the patient during a visit which was the case with this patient,” he said..

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.All Snyder ever wanted was to feel better. Today, she often is immobilized by pain..Before the latest stimulator, she could walk, stand and cook meals. Now, she finds it hard to get out of bed and rarely leaves her house. She says the device has ruined her life....

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“My fear is I’ll be like this forever,” she said...

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators – Shortcomings of Evidence


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Shortcomings of Evidence for

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Spinal Cord Stimulators

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The journal Practical Pain Management has published a presentation of spinal cord stimulators, SCS’s, made at the International Association for Study of Pain, IASP, World Congress. This adds greatly to my concern that they not be trialed for those who have Complex Regional Pain Syndrome, CRPS. About 8,000 visits per year on my website, double any other topic on pain, are about the damage these devices have inflicted, and the comments are gruesome. See search function, top left above small photo.

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John Markman, MD, recounts what’s currently on the table for SCS and how much more is needed for adequate pain relief. A 2018 IASP World Congress on Pain highlight.”

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“In a presentation titled “Yes, We Now Have the Evidence, But..,.” John Markman, MD, professor of neurosurgery at the University of Rochester, outlined some shortcomings of the existing evidence for spinal cord stimulation (SCS) including heterogeneous populations studies.Dr. Markman’s main concern with SCS is the level of uncertainty he has with the procedure—how it works, whom it works for, and the non-specific treatment effects of the procedure. To rectify this, he has begun to conduct crossover studies in his practice to get a better grasp of these questions. “Imagine if, in 2018, the indication for putting in a spinal cord stimulation system were as matched to mechanism as a cardiac pacemaker,” Dr. Markman posed the audience, noting that SCS implementation remains heavily dependent on self-reporting.”

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…snip…

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“Existing Evidence”

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“SCS technology is still evolving, Dr. Markman said. While self-reporting is still prevalent, what has changed in the past five decades is the upgrade from a single case report to prospective, multinational, randomized clinical trials. One landmark trial, for instance, randomized 100 failed back surgery syndrome (FBSS) patients with predominant leg pain of neuropathic radicular origin to receive SCS plus conventional medical management (the SCS group) or conventional medical management alone (the CMM group) for at least 6 months.Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction. Between 6 and 12 months, five SCS patients switched to CMM, and 32 CMM patients switched to SCS. At 12 months, 27 SCS patients (32%) had experienced device-related complications. In selected patients with FBSS, SCS provided better pain relief and improved health-related quality of life and functional capacity compared with CMM alone.”

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“Other significant trials for SCS include North, et al, from 2005,3 and Kemler, et al, from 2008.4 “This is an era marked by open-label studies,” Dr. Markman said. Enormous technical innovation, improvement of clinical trial designs, and larger study populations (prospective, head-to-head), are just some of the factors leading these recent advancements.”

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“Evidence Still Needed”

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“Despite the success in recent years of more trials being applied to SCS, many questions have yet to be addressed. For instance, the totality of study participants to date is only 973, a study population that is “poorly characterized,” according to Dr. Markman. “Chronic pain after spine surgery, that’s an iatrogenic injury, and it’s a very heterogeneous group of patients, some of who have axial-predominant neuropathic pain.” In one study,5 of 97 subjects who completed a trial of HF10 therapy, 90 (92.8%) had significant back pain relief and were eligible for an implant of an SCS system. In comparison, 81 of 92 subjects (88.0%) were successfully trialed with traditional SCS (P = 0.33). “Which is incredibly high in my opinion. Think about in your own practice how many times you’ve tried someone on a therapy for a heterogeneous pain problem, some of which is nociceptive, some of which is neuropathic…and 92% of them get relief? It just doesn’t reflect anything in my practice,” Dr. Markman said.”

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“In addition to this, the lack of blinding in trials, as well as the lack of controls, makes the results weaker by design. External challenges include the regulatory framework for devices being much less rigorous for analgesic drugs, for example. Study sponsorship has also been an issue, as many current studies that are industry-sponsored have a clear publication bias compared to payor studies that are normally negative in nature, Dr. Markman suggested.”

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“Devices are also constantly changing. “It’s a moving target,” he said. “It’s like comparing your phone in 1967 to your phone today. It’s not really a great comparison.” A generation of studies now has emerged that has made comparisons to figure out what the on-target analgesic actions are and what non-specific treatment effects have been seen. “The disruption in technology is changing the stakeholders and how they engage,” Dr. Markman said. He concluded by noting that, due to an impact-style meeting having an enormous accelerant effect on deciding the “rules of the road” for oral analgesic trials, a group is now meeting with representatives from the International Neuromodulation Society and the North American Neuromodulation Society to develop consensus guidelines for spinal cord stimulation.”

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Have You Been a Victim of Felony Fraud Criminal Charges by Workers Compensation Insurer Because of Disabling Pain?


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No one can see pain and neuropathic pain is especially difficult to treat. It may be even more difficult because there may be no visible abnormality on X-ray or any test, e.g. Complex Regional Pain Syndrome (CRPS). CRPS  is further unusual as it may flare profoundly for a time and may even go into remission then flare some time later.

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But many forms of pain including chronic spine pain can flare hours later or the next day. Your walking may appear normal, but you know that limit beyond which you dare not step a foot more or revenge of the body will occur and you will be unable to function possibly for days. No doubt you’ve learned that limit may vary with the weather, or you may have good days and bad, able to walk longer or function better on good days.

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Sub rosa films are important to prevent insurance fraud. Some who claim total disability have been filmed  playing soccer, water skiing, etc. Others with legitimate total disability claims have been filmed during brief periods showing their gait appears normal. They can walk. But only for minutes.

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Abuse may exist on both sides. But it took 43 years for me to discover that pain is not an accepted medical condition for Social Security Disability even when completely disabling.

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Your comments of your personal experience would be invaluable for others. Did you experience fraud and abuse by insurers who deny medical care based on brief sub rosa films, then become victimized by criminal felony charges that produced years of extremely costly litigation?

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As long as felony criminal charges are pending, neither Medicare nor Tricare nor Social Security Disability payments can be made. No insurance, no care and litigation expenses that go on for 5 to 10 years or more in a person unable to work.

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It is important to expose fraud on all levels. If you have been a victim of Worker’s Compensation insurance fraud accused of felony misrepresentation, please comment below.  Name names of the companies.

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Perhaps there is a pattern.

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Would you be able to pay for adequate legal representation if you were unable to work or receive medical care?

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Soothamide (PEA) Cream Helps Psoriasis & Seborrheic Dermatitis


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I have posted on PEA (palmitoylethanolamide) for several years on this site – use the search function top left above photo and type in PEA. No prescription is needed. Before it was available in the US, patients ordered it from the Netherlands where it is sold as PeaPure. One whose neuropathic pain was finally relieved by it, ran out, flew to the Netherlands just to pick up an emergency supply and flew back immediately. Thankfully Vitalitus began offering PEA capsules in the US a few years ago, and then made the 2% cream called Soothamide, which I have also posted on this site. It may even relieve the neuropathic pain of Complex Regional Pain  Syndrome (CRPS).

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Palmitoylethanolamide (PEA, or PeaPure in Netherlands) is nontoxic, anti-inflammatory, analgesic, and has no side effects. Your body makes it; plants make it. Years ago the publications on it were extensive. A Nobel Prize winner published on it in the early 90’s. When taken in capsule form for CRPS, I have seen it take 6 or 8 weeks to be effective, but when it relieved pain, it lowered pain from very severe to mild in a patient bedridden for 6 years. I have seen the cream relieve neuropathic pain instantly in a couple minutes in some with CRPS. I have seen the cream fail to relieve CRPS pain in one patient, who then wiped the remainder of the cream along the lumbar spine of her dad who had been groaning with pain, who had instant relief. And I have published on its use for vulvodynia, discussing its autocoid mechanism.

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Skin conditions can be their own constant day and night torment. A patient reports almost complete immediate relief from the itch of psoriasis and seborrhea (around eyes and all over scalp). Itch can be a form of neuropathic pain besides more common causes such as allergy. The rash, the bleeding crusted itchy skin of those two conditions is treated by prescription steroid creams that can thin the skin, and thin skin itself can predispose to bleeding, further discomfort, and frankly did not help this patient. If you use steroid creams, it must be applied 3 or 4 times a day and use gloves or caution where you rub your fingers — risk thinning the delicate skin near eyes and nether regions as weeks and weeks drag on. Soothamide worked quickly, not needing 3 or 4 applications per day.

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Instantly the itch was markedly better. And overnight! the rash was markedly improved. The patient had had some mild relief from the bleeding itchy scabs on scalp with T/Sal shampoo but not great, for weeks and weeks. Before that, DHS Zinc shampoo helped only mild “dandruff”, did not touch the crusts and itch. Aloe Vera helped the itch for a few hours. Steroid creams were no help for itch, for 4 months scratching the delicate skin around eyes with hard scratchy cloth almost like a dry loofah sponge. Soothamide 2% took away the itch around eyes immediately though it can easily get into eyes when washed or when rubbing the eyes, it does not burn. It is truly very soothing.

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It’s also a remarkable moisturizer, absorbs very quickly, is not greasy, and for those whose other skin conditions are unusually thickened, it would likely be worth a try.

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I see Vitalitus now also sells CBD, that is cannabidiol, the cannabinoid from the marijuana plant that has no psychotomimetic properties – does not make you “high”. GW Pharmaceuticals’s “Epidiolex”, their CBD, recently received FDA approved for epilepsy. Imagine! a Schedule I drug received FDA approval! hmmm, must not be deadly after all. Wait til the DEA kills that idea. Does congress make sense when they dictate medicine?

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Memantine for Neuropathic Pain & Complex Regional Pain Syndrome, CRPS


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Neuropathic pain syndromes show an over-expression of NMDA receptors in the brain in animal models. Ketamine blocks the NMDA receptor. Another medication with the same mechanism, but in pill form is memantine. This report on six patients of the use of memantine for Complex Regional Pain Syndrome (CRPS) from 2007 in the Clinical Journal of Pain, six months after treatment with memantine, showed significant decrease in pain, improved motor symptoms and autonomic changes, and fMRI changes on the affected side improving, comparable to the unaffected side of the brain.

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It was approved for Alzheimer’s dementia gradually titrating to a dose of 28 mg/day, but for decades has been very useful off label for neuropathic pain including but not limited to CRPS, at a dose of 55 mg/day, and in recent years often prescribed for migraine.

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Ketamine is highly successful also for treatment resistant depression, and one patient, a psychiatrist disabled from the unfortunate triad of intractable neuropathic pain, migraine and treatment resistant depression, while slowly titrating to a dose of 55 mg/day, a process that takes almost 3 months, found depression relieved for the first time in decades at the dose of 35 mg. It was highly effective as one component of the multi-pronged approach for all three conditions.

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This life is a hard fact. We all need all the help, encouragement and positive attitudes we can get. Complex intractable pain and/or depression requires rational polypharmacy, selectively chosen based upon well known mechanisms, neurotransmitters, receptors, hormones, stress reduction, cognitive behavioral therapy, physical therapy, occupational therapy, nerve blocks, and spiritual understanding, etc. Several choices were summarized almost two years ago here.

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In my experience, memantine is very well tolerated with few if any side effects but covered by insurance only for mild to moderate dementia. Thus, not only is it highly challenging to treat neuropathic pain, but important to creatively meet the challenges of our backwards medical system that barely recognizes the needs of those with chronic pain.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulation, Current Status 2017


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One of the top read articles in 2017 from the journal Pain (free pdf).

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Click title below:

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Current status and future perspectives of spinal cord stimulation in treatment of chronic pain

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Geurts, José W.a,*; Joosten, Elbert A.a,b; van Kleef, Maartena

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3. Complications and side effects

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“Complications and side effects (adverse events) acquiring reinterventions often occur during treatment with SCS.6,8,16,20,37 Complications include deep and superficial infections or equipment-related side effects like hardware malfunction, lead migration, fractured electrode, pulse generator discomfort, and battery replacements. Localized pain over the implanted hardware occurs regularly, on average in 6% of cases.6 This pain, for instance, can present as pain around the implanted pulse generator or over the lead. Such pain typically leads to replacement of the lead and therefore an additional surgery. Removal of the SCS system may be necessary in cases of deep infection or treatment failure. A prospective study performed over 12 years8 showed adverse events in 61% of patients. However, the complication rate was significantly reduced during the last 4 years of the study from an annual mean of 30% to 22%. The authors concluded that this was likely due to technological developments and improvements in the SCS hardware. Another explanation for this reduction is that the physicians treating patients gradually gain experience in a particular implant technique.22 New implantation techniques like DRG-STIM have been reported to cause more complications and it has been concluded that refinement and optimization of the technique are needed to minimize adverse events.22

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5. Future perspectives of spinal cord stimulation

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….”A point of concern is that, at present, cost-effectiveness of SCS is impeded by the high cost of the device and the high incidence of complications and side effects requiring reintervention and surgery. Consequently, SCS treatment is not accessible for everyone in the world and up to now is only available for selected indications.”….

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Among problems from spinal cord stimulators that I have seen in those with CRPS, the procedure has created a new pain that is now #1 most severe, often at the battery pack that is placed at the low back. Several patients reported units were explanted with difficulty due to severe scar formation.   

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Reference

[8]: Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M.

Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up.

Neuromodulation 2013;16:523–9; discussion 529.

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Objectives: Spinal cord stimulation (SCS) is an effective treatment for intractable complex regional pain syndrome type I pain. Long-term data are scarce on effectiveness, degree of pain relief, predictors, and complications.

Materials and methods: From 1997 to 2008, 84 consecutive patients who received an implanted SCS system after positive test stimulation were included in the prospective study. Treatment effectiveness was assessed annually as measured by mean visual analog scale pain scores and with the Patients Global Impression of Change scale. Treatment success was defined as at least 30% mean pain relief at end point and treatment failure as explantation of the system. A Cox regression determined if baseline factors were associated with both these outcomes.

Results: During 11 years, 41% (95% CI: 27-55) of the patients experience at least 30% pain relief at assessment end point. During 12 years of follow-up 63% (95%CI: 41-85) of the implanted patients still use their SCS device at measured end point. Pain relief of at least 50% one week following test stimulation is associated with a higher probability of long-term treatment success. In 51 patients, 122 reinterventions were performed over 12 years; 13 were due to complications, 44 to battery changes, and 65 reinterventions were equipment related.

Conclusion: SCS provides an effective long-term pain treatment for 63% (95%CI: 41-85) of implanted patients. Forty-one percent (95%CI: 27-55) of SCS treated patients have at least 30% pain reduction at measurement end point. The number of reinterventions after implantation due to equipment-related problems, battery changes, and complications is 122 over 12 years of follow-up. Sixty-one percent (N = 51) of the patients had at least one reintervention. Mean pain relief of at least 50% (visual analog scale) one week after the test stimulation is associated with long-term treatment success.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Cannabis That Can Stop the Munchies? What is THCV?


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MEDICAL MARIJUANA

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Cannabis is legal in California for adult use as of January 1, 2018. This may be helpful to someone you know. It is a most important drug. Below you can find a few pointers that are basic to understanding what strains to try. Distributors are swamped with ten times as many buyers as last week, prices are doubled, taxes are very high, it is very expensive and you will need to test many strains before you find what works for you without making you stupid with euphoria that lasts 12 hours. Do be warned of turning the body into sofa-size obesity overnight. Munchies occur with high THC strains. To discuss below how to avoid that torture and still relieve pain or muscle spasm.

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Horvath et al at Yale in 2015 found cannabis stimulates hunger and arousal in hypothalamic neurons. Here’s the YaleNews on the multi-authored work.

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Horvath is the Jean and David W. Wallace Professor of Neurobiology and of Obstetrics, Gynecology, and Reproductive Sciences, director of the Yale Program in Cell Signaling and Neurobiology of Metabolism, and chair of the Section of Comparative Medicine.

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To orient you in the quote below, cannabinoid receptor 1 (CB1R) is one of the two known cannabinoid receptors in the brain. Others are located outside brain, throughout the body.

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“The Pomc gene encodes both the anorexigenic peptide α-melanocyte-stimulating hormone, and the opioid peptide β-endorphin. Hypothalamic pro-opiomelanocortin (POMC) neurons promote satiety. Cannabinoid receptor 1 (CB1R) is critical for the central regulation of food intake. CB1R activation selectively increases β-endorphin but not α-melanocyte-stimulating hormone release in the hypothalamus, and systemic or hypothalamic administration of the opioid receptor antagonist naloxone blocks acute CB1R-induced feeding.

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Interesting. Low dose naltrexone, which is essentially long acting naloxone, may block munchies in humans? At what dose? Please comment if you take naltrexone 4.5 mg or 15 mg (anti-inflammatory doses) or 28 mg (weight loss dose) or 50 mg and above doses of naltrexone (high doses for addiction).

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One strain that is better at stopping or reducing the munchies, and that is believed due to a cannabinoid in the strain called THCV. You can always do a search for THCV.

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Cannabis is one of the few medications that can relieve some of the worst side effects of opioid withdrawal. Many patients find they need to use fewer opioid pills for pain or can stop them altogether; they need to use fewer muscle relaxants; and they can eat or sleep better if they use cannabis. Once cannabis became legal, many alcoholics were able to give up alcohol because their first preference is cannabis.

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Get a low cost recommendation for medical marijuana in minutes at home from your mobile phone. The best source for recommendation is : HelloMD.

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Cannabis may be legal in all states once tobacco companies toss some money at Congress. Could cannabis be related to the vow of Phillip Morris and a wave of big tobacco companies to stop selling cigarettes this year?

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It is dreadfully expensive and heavily taxed. All states should adopt New Mexico’s law that allows healthcare insurers to reimburse patients who have paid for medicinal cannabis. Voters…

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Cannabis is made by the body and the brain makes two of the endogenous cannabinoids. If is highly anti-inflammatory, and profoundly important mainly in the immune system but also in bone turnover. You have more cannabinoid receptors in your body than any other kind. It is as old as sponges, an ancient medicine.

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A WORTHY READ

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Mr. X – by Carl Sagan who describes his experience with marijuana at length and used it creatively for decades opening his brain to experiences he was otherwise not oriented to at all.

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MUNCHIES

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Fear the munchies. Cannabis, medical marijuana, can cause the munchies, an overwhelming desire to eat nonstop, usually all the most high calorie things your desperately fevered brain can dream of cramming in.

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Certain strains of cannabis can be life saving for those who have loss of appetite from conditions such as cancer, HIV/AIDS, depression, inflammatory conditions, etc. But the munchies can be disastrous when you cannot afford to gain weight due to pain or disability or simply wish to develop an important standard to maintain best health which means good lean body weight. The best way to reduce inflammation is to avoid obesity, avoid sugar, avoid diabetes, heart attacks, strokes. Remember inflammation is the root cause of 90% of the conditions we die of: diabetes, cancers, Alzheimer’s, Parkinson’s, autoimmune disease, atherosclerosis, etc.

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Those with an eating disorder should scrupulously avoid those strains that are highly rated for helping anorexia, loss of appetite.

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CHOOSE STRAINS THAT STOP THE MUNCHIES

STRAINS WITH HIGH THCV  OR HIGH CBD 

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If needing high THC for pain or appetite, for example, then a strain with high THC and high THCV is Durban Poison. Read in detail about strains on leafy.com using the search function and it will find dispensaries in your area.

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If low THC is all you need, then Leafly discusses high CBD strains with low THC currently available. Google it or ask the dispensary.

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I am not going to do more than mention these three cannabinoids: THC, CBD, THCV. You can google them but do glance at my outdated 2009 cannabis website – CBD has vastly changed since then, available even at farmer’s markets and nutrition departments of groceries.

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The cannabis plant has 400 chemicals of which about 86 are known cannabinoids but we focus on just a few and hybrids have been bred to display many qualities and various percentages of cannabinoids.

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THC

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THC, tetrahydrocannabinol, can cause euphoria and is the principal psychoactive ingredient useful for pain, depression, appetite, multiple sclerosis, fatigue, stress, and many conditions including just to have fun, be giggly or creative. For the California Medical Board, a strain with 18% THC is considered high, but some strains such as Holy Grail have 27% or more THC. Some strains are noted for causing more anxiety or paranoia due to THC content. It is widely said THC is necessary for pain relief but… see CBD below.

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CBD

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CBD, cannabidiol, a non-psychoactive cannabidiol that blocks the psychoactive component of THC so that you may be able to mix with THC in order to use a stronger dose of THC for the underlying condition —  find your best ratio of CBD to THC. Or use 100% CBD. Among strains of flower sold at dispensary, I’m not sure what % CBD

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Some people are highly sensitive to THC (paranoia, panic attacks, anxiety) and cannot use any THC or only very tiny amounts of THC with higher percentage CBD.

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Some use pure 100% CBD which is said to be useful for Crohn’s Disease, PTSD, multiple sclerosis and certain seizure disorders, the severe childhood Dravet Syndrome. There is a recent single report of an adult who failed all anticonvulsants and responded to CBD alone. I have seen a patient with depression after 2 years of severe disability from 4 major chronic pain conditions, surprisingly all pain 100% relieved by CBD. It is widely said that THC is essential for pain relief but for this case not needed.

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Some dispensaries will mix liquid CBD:THC in ratios of 15mg/mL CBD to 0.1 mg/mL CBD all the way up to ratio of 15:15 or more. Use topically, under tongue or swallow. One patient dilutes and uses topically. Very expensive!!! It is the only thing helping his extremely painful autoimmune neuropathy.

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THCV

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Leafly discusses ten strains that will not make you (as) hungry

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After discussing high CBD strains, then turn to high THCV:

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High THCV Sativa Strains

“By now you know what THC and CBD is, but you may not be familiar with the less ubiquitous THCV, a related chemical that suppresses appetite. While most strains on the market today tend to test anywhere between 10-20% THC, what’s considered a high THCV content might only hit a high-water mark of 5%. THCV tends to be more abundant in sativa strains, and it’s possible you’ve noticed that sativas tend to provoke hunger less than indica strains. The unique metabolic effects of THCV even have researchers considering its utility in treating obesity and diabetes.”

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Durban Poison is the name of the strain with highest THC and THCV, and a good profile detailed on Leafly: Maximal effect is Energetic > happy > uplifted >> focused >> euphoric. Not everyone may have all these effects.

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Always check Leafly’s negatives for each strain and look at the bar graphs — how severe are the side effects? Note that always worst is dry mouth. Half as bad are dry eyes for this strain – at least not as bad as dry mouth; and much lower in incidence is dizzy, anxious, paranoid. Overall a very good profile for a high THC strain.

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RISKS

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Note, those with Sjogren’s Syndrome who have dry eyes are at risk for corneal transplants and who have dry mouth are at risk for all teeth crumbling, so choose and treat accordingly.

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Cannabis can increase pulse and blood pressure which can be a risk of heart attack and stroke for any age. It is especially likely if you are naive to the drug, i.e. have never used it or have not introduced it to your system for decades. Check blood pressure and pulse before use and after you feel the peak effect.

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The youngest person I found on the internet who died of heart attack caused by cannabis was a healthy 17 year old male, possibly a false report, but cardiac arrhythmias can be fatal and there are undiagnosed cardiac conditions in young athletes who may be likely to use cannabis.

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Cannabis can interfere with memory.

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The adolescent developing brain may be vulnerable to harmful effects.

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HOW TO USE IT

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Vaporize it. Avoid 4 toxins. Rapid onset, short duration of effect.

If smoking, you will inhale 4 major toxins.

Use under tongue or topically on skin.

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If you swallow cannabis, you will not feel effect for 90 to 120 minutes so allow 2 hours before you add more or you may seriously overdose. Duration of effect may be 4 to 12 hours or more – overdosing can last days.

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5 mg oral THC may be too much for a starter dose for some people, but may be average for many, and some may need 10 mg. But heavy users need far, far more: TOLERANCE DEVELOPS!!! Money down the drain. Use only as much as you need or you will develop tolerance and require more frequent and higher and higher doses to reach same effect. That can be unaffordable for the average middle class person. 

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And yes, it may appear in urine for 30 to 60 days, possibly more.

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Cannabis is still a schedule I drug. The Emperor has no clothes. Do not take it onto planes or attempt to mail it.

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Do read more about it on my cannabis website linked above. It is a drug. You will benefit from learning how to use it.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Best wishes to all!


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Please ignore the Advertising – has nothing to do with me.

Anger


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Anger at the failure of our medical system to support research and treatment of pain, anger at failure of the few currently available analgesics, anger at lack of interest or funding from Pharma – it requires at least $10,000,000 more to finish one important human treatment before submitting to FDA – that’s just one study. Pharma does not care, the price is peanuts to them. At one point, a company bought it, intending only to bury it. They do that for rheumatology treatments too, both the innate immune system and the adaptive immune system are being ignored. What could be more powerful than the immune system?

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Anger

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Anger at the failure of most medical organizations to discuss cannabis, medical marijuana. Training in cannabis is imperative.

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I am thrilled that Scripps Memorial Hospital Grand rounds in 10 days is a one hour lecture by the doctor who is head of HelloMD, national leaders in physician approval for medical marijuana, and in education.

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Anger at the destruction of the field of pain management. I posted on this two days ago, top left column. Anger at the greed in the medical system where pharma can buy whatever they want by sprinkling money at congress who will never ever ever do anything about the unholy prices of drugs. Certain elements in power will never stop trampling on the poor and the disabled. They will never treat the addicts. There is no will, they are paid off and nobody wants to help the disabled, the unwell, the poor. Not in  the U.S. Voters do not want to hear it.

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Anger says step back, surrender.

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There is nothing anyone can do. The swamp is exhausting, dirty, dangerous and black.

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I have tried 7-1/2 years to introduce a new paradigm. At various lifetimes in medicine, I have had funding, sat on boards of companies, and panels at FDA. I have witnessed the destruction of what it once was 43 years ago when I entered practice. A long and tortured history, but still the most exciting thing in the world is medicine, science. So what? They shut off the field of pain and are killing it. The world is the world. Always was, always will be. Lust and greed, says the sage. You cannot uncurl the curly tail of a pig, says the sage. Always was, always will be. Do your duty. You cannot escape it. But surrender to love.

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Surrender. Do what you can and surrender the results to the Infinite.

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Read these books:

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Dying to Get High, Marijuana as Medicine

by Wendy Chapkis and Richard J. Webb

NYU Press 2008

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From back leaf:

“How can a substance that is no mystery to half of all adults in the United States prompt such confusion and misrepresentation in the realms of law, medicine, and policy?…. Offering nuance in place of slogans, Dying to Get High tells an inspiring story of the tactics and philosophies of a little-understood health movement.”

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“A beautifully written account from the front lines of the struggle between a federal drug war complex determined to keep demonizing marijuana and the growing movement of patients and doctors who have found marijuana to be a valuable medicine.”

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“….. Provides a human element to the history, pharmacology, psychology, and politics of medical marijuana in a way that no other work has. I loved reading it.”

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Heroin Century

by Tom Carnwath and Ian Smith

Routledge Press, London

2002

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This is an extremely important, amazingly interesting, readable book for everyone.

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From back cover:

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Is heroin really dangerous? Or Is it just dangerous because it is illegal?

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Page-one 93,

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“The income of the drug barons is an annual $254 thousand million dollars, greater than the American defense budget.”

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Read this book. A page turner! Exciting! fast paced, awesome! mind boggling!

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And just because you might flash some anger to propel you to actually do something, don’t get stuck there. Be at peace. Work hard. Use your expertise. Surrender to the Infinite.

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While you are thinking about it, tell Congress to make pain management a mandatory course in more than the current 3% of medical schools, less then 30 hours in 4 years. Fund research and treatment of neuropathic pain such as CRPS, Complex Regional Pain Syndrome because it can be so disabling – the same neuropathic pain can occur from strokes. Don’t we deserve better? Not even cancer pain is taught, let alone grade schoolers who should be taught about the body, about addiction, drugs, sex. Teach all that opioids cause pain because they trigger inflammation in the immune system and that stimulates pain. The more opioid you give, the more the pain. Teach about the brain’s pleasure centers and addiction, how drugs and food and cigarettes work there and how addiction kills.

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Have a wonderful life all of you. There’s a lot of work to take up. You will meet great people. Can’t wait to see what a little anger will do.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Ketamine & Opioids Stop Working – TOLERANCE – the body no longer responds no matter how high the dose


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The comments below on ketamine tolerance apply to its use either for intractable pain or major depressive disorder. I have written about ketamine several times since April 2009. Tolerance means the medication no longer has an effect. If ketamine is to be needed for decades to come, we don’t have more than 10 years experience with repeated use to understand if and when it will stop working for our patients.

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Tolerance to ketamine is a growing potential as more infusion centers open each year.

Infusions are being used at fixed dosages

that are often too high or toxic

and predispose to tolerance and loss of efficacy.

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I’ve seen two cases of ketamine tolerance since about 2009 among persons with Complex Regional Pain Syndrome (CRPS). And the neuropathic pain of CRPS responds differently than other pain syndromes. We are all snowflakes, not one of us is alike another. But CRPS is unpredictable in many ways, and very predictable in others. It is also more dynamic and capable of being reversed in many who have it.

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Ketamine is given usually IV in a few centers in the country for CRPS and for Major Depressive Disorder. I prescribe it either via nasal spray or under tongue. I may, later this year, offer IV infusions to a small number of my patients who need both.

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If tolerance develops, would drug holidays work?

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Some people develop tolerance to their medication. In the old days, when I was training in the 1970’s, Parkinsons medication over time would stop working. Our only recourse was to do an inpatient drug holiday for weeks. We had to stop the drug. The resting tremor, the constant flailing, was exhausting and life threatening, especially if you had a heart condition. Newer Parkinson’s drugs completely circumvent this.

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Would drug holidays work if tolerance develops for ketamine or is it a goner forever?

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Opioids can cause tolerance through a known mechanism. They produce inflammation that causes more pain. Higher and higher doses fail to help pain. Addicts seek the high they once felt but cannot capture. This is why addicts die, chasing the impossible. Detox. Drug holiday. In the case of addiction, many are placed on Subutex, an opioid that acts on two opioid receptors and seems to prevent craving, in part at least because it has such a long half life that the blood level never dips.

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Ketamine infusions centers springing up.

Is that all they do?

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NIH and Yale began to test IV ketamine infusions in the 1990’s for major depressive disorder, and Robert Schwartzman, MD, at Hahneman in Philadelphia was one of the early ones to infuse ketamine for CRPS and contribute a large body of research on this pain.

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But in the last 2 or 3 years I receive a growing number of mailings advertising ketamine infusion centers. Just that, nothing more. Ketamine infusion centers, not pain specialists. All these young anesthesiologists popping out of training every year have a cash pay business; insurance doesn’t cover.

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Will ketamine stop working for patients who need to use it regularly for decades and decades? We don’t know. It should be studied.

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The first patient I saw with ketamine tolerance, I referred from San Diego to Professor Schwartzman in Philadelphia. She received inpatient IV around the clock for one week, then outpatient IV boosters every month. After eight months, she stopped responding. That’s when I called him to ask what to do? He did not know. So I used glial modulators. I posted her case years ago. She is in her 70’s, pain free since 2010, and two weeks ago, as a volunteer for the Red Cross, she supervised RN’s and evacuees from the flooding at Oroville dam. Tens of thousands of people, emergency care for families and homeless.

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A recent patient has had more than 20 surgeries in her hand that has CRPS. She has failed  IV ketamine, opioids, propofol given together in ICU for weeks and weeks. Surgery triggers the glia to produce neuro-inflammation.

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Another case though unusual, also posted years ago, a young male athlete, bedridden with CRPS affecting almost entire body. Flew to Professor Schwartzman 9 times and each time, the relief was gone by the time they reached the airport. He was taking opioid medication that may have been impossible to offset.

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This is what I advise when I prescribe ketamine for my patients to use at home as a nasal spray or sublingual:

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  1. Do not use it with opioids.Opioids cause inflammation, ketamine does the opposite. It modulates (reduces) inflammation.

  2. Never use it alone. It is a glial modulator, it is not only an NMDA receptor inhibitor.

  3. For intractable, treatment resistant cases, use as many glial modulators as you can.

  4. Ultra low dose naltrexone (20 micrograms TID) can profoundly reduce tolerance in patients on opioids: they may now need 1/2 to 1/8th the dose of opioid that simply had never quite done enough. Naltrexone not only relieves pain, it may profoundly improve function.

  5. Opioids stimulate glia to produce pro-inflammatory cytokines -> pain. Stop opioids if you can. You are likely to get far better results with glial modulators, especially if you have CRPS.

  6. Pain specialists should be offering a trial of glial modulators before they choose opioids for life.

  7. Use glial modulators as needed: ketamine, oxytocin (a hormone), tricyclic antidepressants (weaker than the others but can be profound for some), metformin.

  8. Metformin, a glial modulator!  for pain! in people who do not have diabetes. I will be posting on it this coming week — inshallah

  9.  Use it sparingly. Whether ketamine or opioids, use sparingly because of tolerance.

  10. If it is a good day, use less and use sparingly. If pain spikes, use higher dose, use sparingly.

  11.  When tolerance develops to ketamine, what then?

  12. Is it possible that a drug holiday would work? Should that be in months or years? we may never find out.

  13. Use ketamine and/or opioids sparingly. Prevent tolerance. You may not always need the same dose on a good day or when pain spikes.

  14. Make sure you are doing other things to relieve pain, not just ketamine or opioids.

  15.  Dextromethorphan helps, a sigma I receptor antagonist that reduces the excitotoxic glutamate

  16. Try as much as you can to exercise.

  17. Lift the mind to positive things. Learn to block thoughts of pain, dissociate from that. Choose life and doing and being.

  18. Develop momentum. Try never to judge; that includes being hard on yourself and others.

  19. Expand your spiritual life. Find your path if you don’t already have one. It may begin for all sorts of reasons, but figure it out. It’s real. Spiritual giants from all paths have had direct perception of the infinite in many ways and forms. Direct perception.

  20. S-ketamine clinical trials are now ongoing in the US. I was very disturbed to hear the side effects of S-ketamine infusion related last week. S-ketamine deeply disturbing. It is wrong to give everyone the same dose of ketamine. Not once have I ever heard anyone recount similar side effects from ketamine infusions. I got the impression from her they were not inclined to attribute it to S-ketamine, but it would be disturbing if they did not. Ketamine’s dose no matter how you give it is idiosyncratic, meaning some respond to 2 mg, some to 400 mg. It is wrong and should be unethical to subject someone to doses 200 times the dose they may need. It is dangerous and promotes tolerance.

  21.  If you’ve been stuck in bed, branch out and vary the things you do. Find music and poetry and literature. Maya Angelou suffered yet her words make you soar. Check out James Baldwin in the Oscar-nominated documentary “I Am Not Your Negro.” Baldwin’s immensely powerful analysis deconstructs movies, not as a mirror, but as a window into the imaginary; and how movies shape our thinking. As a movie critic, his writing is about poverty, class and “not everything that is faced can be changed, but nothing can be changed if it is not faced.” …  “There are days — this is one of them — when I wonder, how precisely are you going to reconcile yourself to your situation here…” So many writers fail to teach us how to analyze and think with such clarity. Something we don’t always do. We need to train ourselves to become critical thinkers. Baldwin brilliant mind demonstrates critical thinking at its best.

    Critical thinking is not a partisan issue. Tens of millions will lose jobs as robots rapidly take over in the next 3 years. Industry will reap more than ever in history. We all need to rethink our lives at some point.

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    Dylan’s song is about “the possibility that the most important (and least articulated) political issue of our times is that we are all being fed a false picture of reality, and it’s coming at us from every direction.”[10]

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    “Propaganda, all is phoney,” Dylan says in “It’s Alright, Ma (I’m Only Bleeding).”

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    Advertising signs that con you
    Into thinking you’re the one
    That can do what’s never been done
    That can win what’s never been won
    Meantime life outside goes on
    All around you.

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    Public Warning:

    Ketamine is a controlled substance.

    Administered improperly, or without the guidance of a qualified doctor,

    Ketamine may cause injury or death.

    No attempt should be made to use Ketamine

    in the absence of counsel from a qualified doctor.

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    “Off label” means ketamine is FDA approved for another purpose, decades ago it was approved for anesthesia. In qualified hands, ketamine is one of the safest medications we have in our formulary.

     

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    The material on this site is for informational purposes only.

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    It is not legal for me to provide medical advice without an examination.

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    It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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    This site is not for email and not for appointments.

    If you wish an appointment, please telephone the office to schedule.

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    For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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    Please IGNORE THE ADS BELOW. They are not from me.

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Medical Marijuana – Cannabis for Pain


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These references include links to peer reviewed journal articles on cannabinoids. They are taken from the Reference Library of the outstanding RSD Association in Connecticut, whose mission is to help relieve pain. They have grouped the articles in helpful folders by subject, and this is one of many folders on the immense subject of pain. Please donate to them as their research helps everyone with pain, not just nerve pain or CRPS. May the references help enrich your lives and help support congress and regulators in legalizing cannabis across the country — the attorney general just now voted in by congress opposes medical marijuana.

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Be aware that states should monitor the plant for bacteria, fungus, pesticides, and heavy metals as discussed in this Smithsonian article:

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“Washington, the second state to legalize recreational marijuana, does require such testing for microbial agents like E. coli, salmonella and yeast mold, and officials there rejected about 13 percent of the marijuana products offered for sale in 2014.”

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Concentrates may be made with toxic butane or heptane. If you have cancer or are immunosuppressed – cancer and autoimmune diseases fall into that category – it is safer not to inhale. Cannabis can be used on the skin or swallowed but be aware when swallowed, it takes 60 to 90 minutes before you feel the effect. It is easy to overdose when swallowed. Check your blood pressure and pulse before use and again while you feel its effect.

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The article also points out that on testing, many of the plants have high THC but no longer have CBD, one of the 86 known cannabinoids, the one that blocks the psychoactive side effects of THC. On its own, CBD has many medical benefits.

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For those who have allodynia, the most intense form of nerve pain, pain that is triggered by a light touch or breath of air:

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Keep in mind that chronic pain is much harder to treat than cancer pain and acute pain. Chronic nerve pain is the hardest of all to treat. We need to be able to prescribe anything that helps. Pain can lead to suicide in these extreme pain conditions.

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Watch out for the munchies – do not get fat.

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O’Shaunessy’s today published articles that may be useful for your Senators, healthcare insurers and states:

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“some additional articles published by cannabis clinicians in O’Shaughnessy’s showing the strength of aggregated case reports. We hope the MBC Marijuana Task Force will give them serious consideration.”

 

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Cannabinoids

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Spinal Cord Stimulators – comment on RSD


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Spinal Cord Stimulators 

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 Craig’s comment

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By no means do I mean to say that I or anyone else has better insight into how to treat pain, but I am against spinal cord stimulators [SCS’s] for treatment of pain due to CRPS, and possibly against use in other situations. I demand that the billions in profit they made be put into a retrospective and prospective study of damage caused by them in order for them to give full informed consent.

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I have 3 goals writing this.

  1. SCS’s

  2. Craig’s experience

  3. The Only Real Answer for severe pain, not damaging the system with opioids

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Informed consent is never given for spinal cord stimulators because it requires truth telling, something our corporations have been reluctant to do. Business ethics are not medical ethics, as we keep being reminded daily in the headlines.

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I enclose, below, a generously expressed and detailed comment by a man who had the patience to sit down and  write the painfully gory details so you can weigh-in on your decision whether to follow your pain specialist’s opinion to give you one. I don’t want anyone to feel suckered into choosing them and if I had pain I’ll admit I’d crave relief too. Anything. I’d be in line before the doors open.

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But if you have CRPS, spinal cord stimulators will create more pain. CRPS evolves unpredictably, by a will of its own. I know some very desperate patients with CRPS everywhere including face, mouth, gums, tongue, organs, trunk, limbs. Spinal cord stimulators will create more pain. Keep in mind, I don’t see the 5 year success stories even for lumbar disc pain. They don’t need me if they are pain free.

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But if you have CRPS and desperate need for pain relief because all else has failed — every known drug in highest possible doses of ketamine, propofol, opioids for weeks in ICU fail to even touch pain— there is one thing, and only one thing to do and I will set it out below. I just sent my recommendation to a patient with CRPS in extreme pain.

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My recommendation, below, is for patients who have nowhere else to turn.

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First I’ll mention the problems Craig encountered with SCS’s. He sent his comment to the opening page of this blog, so I will reproduce below. 

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I am currently undergoing a trial Medtronic SCS. I have had to have it reprogrammed 3 times since it was installed 5 days ago. I have had sensations and issues that I have addressed with my rep and my neurosurgeon. I get a severe headache when the unit is turned on. I get the constant feeling of having to urinate. I have current running through my testicles which they can not seem to program out and I am getting little pain relief. I have had to failed back surgeries, many failed injections and I have CRPS. The leads that were inserted when I was in the table covered my mid back and both legs. After I got to my feet and waited while they programmed the unit in another room. They came in and plugged it in and I no longer had coverage on the right side. My crps is in both legs, my hands, arms and face. The lyrica helped to tamp down some of the burning but I am in pain 24/7 and this was my last resort. I have scar tissue completely surrounding my S1 nerve. By the grace of God, I am on my feet, on crutches. I seem to get a look of disbelief when I tell them the unit is causing these issues or it’s not giving me the relief I was counting on. Relief, only to cause greater issues and pain. Is not relief to me. I can not wait to get this trial out of my back. I believe the leads slipped and that is why I am not getting the full coverage I had on the table. The issues I have had are as follows: severe headache, constant feeling of having to urinate, extreme joint pain, abdominal pain, sleeplessness, involuntary jerking, surges in current even when sitting still. Intense pain around the lead insertion site. Current uncomfortably running through my testicles, regardless of setting. It is my opinion there is still not a lot known about crps and I have read evidence of people have great success with these units. Everyone reacts differently. My body obviously creates a lot of scar tissue and my orthopedic surgeon created a fair amount herself. I can’t imagine even more or being forced into a chair for yet another unlucky decision. The medication helps and I have lived this far without the optimism that it would end soon. I had high hoed for this device but I don’t think it is right for me.

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One of my patients with CRPS was hospitalized for weeks with recurring unusual abscesses and required repeated surgery of hand and forearm. Even before surgery, she had failed opioids, failed ketamine, and was in ICU for weeks and weeks while the same medications were still given along with Propofol and IV Tylenol. Nothing helps her extreme pain.

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Anesthesiologists on staff in ICU threw everything they had at the pain for weeks. Most anesthesia pain doctors would have probably done what they did because that is the limit of tools we have.

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When you have hit the limit of benefit from opioids, ketamine, propofol, we have nothing else that treats pain with one exception: drug holiday.

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Stop all analgesics including Tylenol that destroys the liver as severely as cancer, the severity of which was newly discovered and published yesterday.

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The receptors for these analgesic drugs have up-regulated to such an extent they have caused the situation. Again, I stress, everything that was done during the ICU admissions would be done by any anesthesiology pain specialist. Those are the only tools. They cause the problem. The same for opioid induced hyperalgesia. We used to do it with Parkinson’s drugs in the 80’s.

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The only way to rehabilitate the up-regulation of all those receptors that have now exploded in numbers, immune to anything you throw at them, is stop the drugs.  Stop all of them for weeks, maybe months, years, no one knows, you are all the human guinea pig waiting to happen. But if we restart them, how long do we wait, how quickly will it again lead to this massive hyper-excitable state of pro-inflammatory cytokines that we know have gone wild, flooding the CNS. A flooded engine will not restart.

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Ketamine at least is known to reduce pro-inflammatory cytokines, but the system is too busy exploding, birthing new receptors that take over, and you’ve got a 55 car pile up. Well, more like millions I’d guess. No scientist here. Clnically, when can we resume something after a drug holiday, how soon and which drug? I’d avoid opioids because they create more pro-inflammatory cytokines. Choose ketamine, because they reduce pro-inflammatory cytokines, but if it works at all, stop it at first sign of tolerance, which is the need for increased dose. It becomes less effective. Walk a fine line, endure more pain because unless you do, it will no longer help. Opioids, analgesics of many kinds. 

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How do we get you through a drug holiday because we know withdrawing these drugs will trigger even more pain for possibly weeks until the system settles down?

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Pain storms, hurricanes

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This is complex regional pain syndrome where we see this insanity of pain storms. There is no other condition, unless several neuropathic pains in people with cancer, nowhere I have seen this type of pain in decades except CRPS – comparable to pain of subarrachnoid hemorrhage, blinding pain.

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No one has answers. None. One university does outpatient infusions of ketamine six hours daily for 8 to 12 weeks. Does it help? A small percentage. Outpatient, 6 hours daily, 5 days a week, staying at a hotel, 8 weeks.

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This is CRPS/RSD. No one has answers. It is futile to throw more of the drug in the system. That is my opinion. You have a choice and may choose otherwise. It is your body. You may stay on monthly opioids for decades, until you finally admit how poorly they work. A drug holiday is what we did in the 70s during my ancient training with Parkinson’s patients. They needed full 24-hour support. The American medical system has changed since then and those are not options currently available—cost.

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You need full psychological and psychiatric support.

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The Only Real Answer

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The country needs to invest $10 million to complete the clinical trials needed for an injectable, long-lasting interleukin 10 [IL-10], the anti-inflammatory cytokine. It already has full scientific and animal studies performed by and with the world’s foremost glial scientist at University of Colorado Boulder. Professor Linda Watkins has won awards from many countries. She has been the keynote speaker at the annual academy pain meetings for years. IL-10 can relieve pain for three months in animals that have intractable chronic neuropathic pain. This is not new —–NIH I’m looking at you to fund clinical trials. And those of you who care, do a Kickstarter to fund the clinical trials.

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This is the power of the innate immune system. NIH would rather fund research on the unknowns like stem cells rather than the known. It’s known for decades, NIH does not like to fund pain research. Glia are not all about pain. They are the innate immune system, the key to Alzheimer’s, neurodegenerative diseases, almost all known disease including atherosclerosis. It’s all about inflammation. We need the trials to stop giving drugs that cause inflammation, opioids —–CDC fiats are not as good as a drug that relieves pain, a drug that really works on mechanism. Where will the addicts go if the ER only has IL-10 for pain? That is one way to overspend on ER visits.  And NIH, please get us some real clinical research funding on how to use glia for our benefit. Get us some research on the entourage effect, combining medications to achieve relief especially for neuropathic pain.

Then bring on some crack negotiating teams from insurers to do some negotiation about pharmaceutical prices. Our new president has mentioned that.

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Please bring this to everyone’s attention. One way to get a grip on pain and/or depression is to build hope, help others, and energize behind a goal.

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Kickstarters work to raise tens of millions overnight. 

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IL-10 – animals have been shown to be pain free for three months, already proven in animal studies, by one of the world’s most widely acknowledged pain specialists Professor Linda Watkins, PhD. We need the final steps to fund the clinical trials in humans.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Pain Much Better off Opioids


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Patient disabled with CRPS/RSD markedly better after off opioids. The intense nerve pain began in his left ring finger eight years ago, not the dominant hand. Now he has pain everywhere below the neck. He has been bed-ridden for years.  Now his “bones feel like ice, freezing from the inside out and shaking.”

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Had been on Fentanyl patch 100 mcg/hr for years. Dose was lowered to 75 mcg/hr, then his pain specialist did an involuntary taper off in two short weeks. Both of those doses are far higher than the new CDC guidelines from 2016. Fentanyl is 100 times stronger than morphine.
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He says his pain is feeling much better off the opiates. He is quite surprised. On Fentanyl 100 mcg/hr patch, he rates his pain then as 6 to 8 on scale of 10.
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Pain is now  2 to 4 off opioids the last 3 to 4 weeks. Even the hands are not hurting as much..

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Initially after the abrupt taper, he spent 7 days in bed, then says he “started getting out a little bit, now hands are not hurting as much. Neuropathy even isn’t hurting as much.”

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I have seen several patients who said opioids caused pain, all over the body in places they never had pain before or since.

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Yes, clearly many are helped by opioids. But many are simply afraid to taper off. I understand this. The question then is, what will we do to treat pain? Most doctors have nothing else. Patients rightfully fear stopping opioids.

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We need to understand there is outstanding science that demonstrated years ago that opioids cause inflammation in the CNS (brain and spinal cord). Inflammation causes pain.

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Treat pain with glial modulators that relieve inflammation in the brain, neuroinflammation. These are off label and most of them must be compounded. Compounded medications are not covered by your insurance — thanks to pharmaceutical donations to congress.

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Cannabis (medical marijuana) can help some with spasm, pain, insomnia. Also not covered by your insurance — thanks to pharmaceutical donations to congress. But patients in New Mexico were able to get insurers to reimburse them for the cost of their medical cannabis.  Congress should allow dispensaries free access to banking systems and allow insurers to directly pay the cost for medical use. We all know the emperor has no clothes. Lets be real. Pain leads to desperate measures.

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Let me say right now, to all those who will send in comments attacking science, attacking me, attacking my clinical experience (my patient reports) on opioids, I will not post your attacks on these pages. I do prescribe opioids to select patients. I strongly believe all pain should be treated initially by glial modulators that relieve neuroinflammation before we begin causing pain and inflammation by ultimately having nothing else to turn to and then prescribe opioids. There is no better solution because pharma wants you on a drug for life. That’s money in the bank, forever, every single month for decades. It’s awful.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Medical Marijuana Proven to Save Lives, Science Issue on Pain, November 4, 2016


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The entire issue is devoted to Pain 

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From “Pot and Pain” page 566:

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Analyzing Medicare drug prescription data from 2010 to 2015 in states where medical marijuana is legal, David and Ashley Bradford at University of Georgia in Athens found significant differences in prescription of medications for anxiety and nausea. “But one condition stood out from the rest: ‘The effect for pain was 3 to 4 times larger than all of the others.'”

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“In medical marijuana states, each physician prescribed 1826 fewer doses of conventional pain medicines each year.” The reduction in pain prescriptions is even more dramatic in the younger Medicare Group.  [presumably disabled by pain]

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Marcus Buchhuber, previously at the Veterans Affairs Medical Center in Philadelphia, examined death certificates in all 50 states between 1999 and 2010. In states that permitted marijuana, there were nearly 25% fewer deaths from opioid drug overdose.

In 2010 alone, “that translated into 1729 fewer deaths” from overdose. And the effects grew stronger in the 5 to 6 years after medical marijuana was approved.

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Further information on Marijuana here.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please ignore the ads below. They are not from me.

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Medication Summary for Intractable Pain, CRPS/RSD


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  Medication Summary for

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Intractable Pain, CRPS/RSD

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I spoke only briefly this morning at the RSDSA conference but there is so much to add. Most importantly, thanks to RSDSA for helping so many people with CRPS. They fund pain research, they are starting a free children’s camp, and now offer physicians one hour free CME teaching about CRPS.

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Holistic view, 36 points – that’s how I view caring for brain and nerves, very similar to the details used by UCLA Alzheimers Research Unit. In June 2015, I posted on their work on memory loss, dementia. We know chronic pain means inflammation in the brain, excess of proinflammatory cytokines. CT scans show memory loss and brain atrophy in those with chronic low back pain.  Can this inflammation lead to Alzheimers? Even if it doesn’t, why not maximize what we know we can do to help brain. As I view it, simply be meticulously detailed in giving the central nervous system (CNS) the best chance to relieve or prevent pain or disease.

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Below is a brief list.

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To find detail and sometimes depth, check the alphabetical lists on either side column until you see the category or tag when I first posted on that. Or simply plow through 7.5 years of detail with references. You do the work to check the side columns as I have no time to embed links below, taken from throughout this site.

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For now just a list of medication players that may be strikingly important in trying to bring intractable pain into remission even after 20 years. Yes, even chronic for decades.

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The list applies to intractable pain of all causes. I omitted listing standard interdisciplinary approaches commonly used by every pain specialist around the world. My patients have failed all those.

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Some patients with CRPS combine my medications with ketamine infusions.

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For those who remain on opioids, ultra low dose naltrexone (10 to 60 mcg three times daily) can significantly reduce pain, reduce opioid induced hyperalgesia, reduce windup, and thus reduce the dose of opioid needed to give improved relief.

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Opioids cause pain and trigger pro-inflammatory cytokines that create more pain.

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I strongly recommend slowly, gently tapering off opioid, and remaining off for 3 weeks before the following is trialed:

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 1. Vitamin D is anti-inflammatory. Important. Helps pain, depression. If bone loss is an issue, you will not absorb calcium from food if D is low. Mayo Clinic’s publication in 2012 showed more morphine is needed for pain if D is low. Huge literature of its benefit for depression. First topic I posted on – it is that important.

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2. Vitamin B6 can cause burning pain from scalp to toe, a toxic neuropathy. It can be toxic to brain. It is loaded in tons of soft drinks, “energy” drinks, supplements.

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3. MTHFR mutation may be present. Body cannot process  the B12 and folic acid you are eating or taking in supplement. A simple blood test, costly. Treatment is as simple as buying methyl folate and methyl B12 – no prescription needed. Folic acid in particular is profoundly important for one of the major energy cycles in the body. Can cause multiple conditions, some fatal, all from one single cause.

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4. Minocycline 100 mg/day is the dose I use but higher doses could be given. It is used daily for decades for acne. I may prevent spread of CRPS if given before surgery, dental work, even minor procedures. I start 24 hrs before, and continue for days after full recovery from surgery.

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5. Testosterone  in either male or female is depleted by opioids, it may be depleted by stress. Low T is a risk for depression, weakness and osteoporosis.

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6. Naltrexone low dose (LDN) – profoundly important. A glial modulator. Lifelong use.

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7. Dextromethorphan – reduces hyperexcitable glutamate

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8. Oxytocin

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9. Memantine – double the Alzheimers dose for CRPS. Like ketamine, it blocks the NMDA receptor.

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10. Lamotrigine

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11. Palmitoylethanolamide (PEA, PeaPure) a glial modulator, also acts on mast cells. A food supplement. No Rx. Your body makes it. Plants make it. Capsules & cream

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12. Ketamine via nasal spray, under tongue combined with IV or not, works on glutamate-NMDA receptor. Not an essential drug. Where ketamine has stopped working, patients have become pain free after years of CRPS.

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13. Creams combinations, so many

most of my CRPS pts very much like   Mg++/guai  10% each.

You may or may not trial various combinations lido/keto/keta, etc. Numerous. DMSO 50%.

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14. Medical Marijuana (CBD, THC, terpenes) Marijuana saves lives. Entire issue of Science, November 4, 2016, devoted to pain.

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NAC and alpha lipoic acid are noted by research from the Netherlands.

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Appendicitis

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If it has not burst, treat it like the infection that it is. Surgery may never be needed. I posted details of publications early 2016 with a case report. That young man was being rolled into the OR, instead was discharged 100% better without surgery 2 days later.
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Medications target 3 main systems

as discussed at the conference

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The opioid receptor – opioids create pain. They trigger glia to produce pro-inflammatory cytokines. Opioid induced hyperalgesia may occur. Cannot be used with low dose naltrexone.

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The glutamate NMDA receptor – ketamine, memantine

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Glia, the innate immune system – glial modulators

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Before they see me, my patients have failed all prior therapies even ketamine coma. I view it like football. You have one guy running down the field with one ball. Do you want to win the game? You’ve dealt with this for years. Let’s not prolong it. Hit it with my main choice of meds all at once. Jump on it. What if you get 10% relief – will you even notice 10% after many years of severe pain? But if you get 10% from each of 5 meds, then you are talking 50% relief as a start. Address those 3 main pain systems – even without ketamine – and I have posted a case report after 20 years and 3 suicide attempts before seeing me, she has been pain free for about 4 years as I recall. A surgeon nicked her sciatic nerve when she was 27. Two years ago, pain free, running on her treadmill, she twisted her ankle. She has permanent foot drop from the sciatic nerve injury, but even spraining her ankle did not flare her CRPS. Twenty years of CRPS, pain free for about 4 years. And ultimately, years ago, she was tapered off all the drugs with one exception: LDN lifelong.

 

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Most importantly, I did not have time to relay a very special message from my patient in Brooklyn:

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.Surround yourself with friends and family who love you.

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She had her first 2 or 3 pain free days this week, as she slowly increases doses of medication. She’s not yet at maximal effect and even then there can be increases. Sending love and courage.

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MOVEMENT

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Watch this on the RSDSA video, afternoon speakers, the parents of young ones who had RSD discussed today all the toys and games they had to devise to slowly force yourself to move through the pain, every single day, several times a day, all day, begin to move the body as much as you can. Set goals and slowly, at a pace you set, do the work. Make progress. Go forward. Keep moving. Do whatever you can to keep moving.

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RSD support groups are essential and I am glad to see the RSDSA list of so many throughout the country.

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There is so much more. Indeed, at least 36 points discussed on June 2015.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please ignore the ads below. They are not from me.

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Neuropathic Pain Medications – review & metanalysis of 229 studies


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This review was done by many of the best pain specialists from all over the world. You will not find answers in that large review if neuropathic pain has already failed tricyclic antidepressants (Elavil, amitriptyline, Norpramin desipramine, others), gabapentin (Neurontin), pregabalin (Lyrica), lidocaine, capsaicin, or opioids. That is the current paradigm. A new paradigm – glial modulators  – that I discuss on this site, may or may not give relief.

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A member of the International Association for Study of Pain, IASP, published a brief critique of that comprehensive review of 229 trials of medications for neuropathic pain published in Lancet Neurology February 2015. The critique is posted below, done by a member of the Neuropathic Pain Special Interest Group, NeuPSIG.

 

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To understand the metanalysis of these 229 trials, you need to understand the simple concept of number needed to treat, NNT.

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NNT is an estimate of “the number of patients that need to be treated in order to have an impact on one person.”

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The smaller the number, the more effective the drug. Example, NNT of 7.2 for gabapentin means you need to treat  7.2 people before a response. If 3, need to treat 3 before a response.

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Barsook (Harvard, ref. below) reviewed ketamine studies in 2009:  “they did show a level of efficacy (of ketamine) based on NNT that equals or betters most drug trials for this condition.”

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“NeuPSIG has just published an up to date systematic review on the effectiveness of pharmacotherapy in Lancet Neurology. They have negotiated with the journal to make it available beautifully open access. You can download it for free here.”

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Neil O’Connell, Brunel University London

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“This is a comprehensive review, containing 229 trials of the full range of pharmacological agents using robust methods, to synthesize, summarise and make value judgements about the quality of the available evidence. So what are the take home messages?”

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“Using a primary outcome of achieving at least 50% pain relief trial outcomes were described as “generally modest”. The number of patients needed to treat with the drug compared to a placebo for one more person to achieve this outcome ranged from a relatively rosy 3.6 (95% confidence interval 3 to 4.4) for tricyclic antidepressants such as amitryptiline, 4.3 (95%CI 3.4 to 5.80 for strong opioids to a less impressive 7.2 (95%CI 5.9 to 9.21) for gabapentin, and 7.7 (6.5 to 9.4) for pregabalin (often sold under the brand-name Lyrica). It’s interesting, at least to me, how much better the older more traditional agents seem to have fared compared on effectiveness to the more modern (and commonly more expensive) agents although the safety and tolerability of gabapentin seems superior.”

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“The spectre of publication bias also raises its head. The reviewers carefully took a number of routes to try to unpick this notoriously difficult issue and estimate that there has been overall a 10% overstatement of treatment effects. Published studies reported larger effect sizes than did unpublished studies. This is not a problem restricted to the field of pain trials. It is a burning issue across the world of clinical trials. It is very important because if we fail to base our clinical recommendations on the totality of relevant evidence (because some data are hidden from us) we are in danger of mis-estimating the benefits and the harms and as a result patients are put at risk. If you think that is pretty important then there are ways that you can help. Check out the All-Trials campaign.”

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“Overall what does this mean? Many drugs are effective but not as effective as we would wish them to be. No pharmacological agent really impresses and for any drug the most probable outcome is failure to produce 50% pain relief. There are various potential reasons for this. The first is that the drugs may only be moderately or marginally effective, another is that neuropathic pain includes quite a mixed bag and our ability to accurately diagnose and to target drugs to specific mechanisms in the clinic is currently fairly poor.”

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“The NeuPSIG review team formulate a number of recommendations for revision of their clinical guideline for managing NP pain, balancing the benefits, harms, costs and strength of the evidence.”

  • a strong recommendation for use and proposal as a first-line treatment in neuropathic pain for tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, pregabalin, and gabapentin;

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    • a weak recommendation for use and proposal as a second line treatment for lidocaine patches, capsaicin high-concentration patches, and tramadol; and a weak recommendation for use and proposal as third line for strong opioids and botulinum toxin A. Topical agents and botulinum toxin A are recommended for peripheral neuropathic pain only.

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“This email [from IASP’s NeuPSIG] is also published as a blogpost at www.bodyinmind.org”

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References

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Finnerup NB, Attal N, Haroutounian S et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14:2:162-73.

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Glial modulators – another paradigm

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From my January 2012 brief review of publications on ketamine, only one of a handful of glial modulators, this author says reviews “show a level of efficacy based on NNT that equals or betters most drug trials for this condition.

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Ketamine and chronic pain – Going the distance, David Barsook, Director, P.A.I.N. Group, Massachusetts General, McLean and Children’s Hospitals, Harvard Medical School, Boston, MA;

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This paper covers essential points not mentioned by many, thus quoted at length below:

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Our current therapeutic armamentarium is quite limited in terms of analgesic efficacy in controlled trials. Some would argue that the small efficacy (both at a population level and the magnitude of change in VAS score) this is related to the fact that we need to consider mechanistic approaches to chronic pain subgroups. However, patients and clinicians find themselves in a position of “what to do now”.

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Ketamine, brain function and therapeutic effect – neuroprotective or neurotoxic

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With the onset of chronic pain (including CRPS) a number of changes in brain function occur in the human brain including but not limited to: (1) central sensitization ; (2) functional plasticity in chronic pain and in CRPS; (3) gray matter volume loss in CRPS ; (4) chemical alterations ; and (5) altered modulatory controls. Such changes are thought to be in part a result of excitatory amino acid release in chronic pain. Excitatory amino acids are present throughout the brain and are normally involved in neural transmission but may contribute to altered function with excessive release producing increased influx of calcium and potentially neural death. Here lies the conundrum the use of an agent that potentially deleteriously affect neurons that may already be compromised but may also have neuroprotective properties by mechanisms that include reducing phosphorylation of glutamate receptors resulting in decreased glutamatergic synaptic transmission and reduced potential excitotoxicity . Alternatively, ketamine may affect glia regulation of glutamate and inhibit glutamate release within glia. However, by whatever mechanism ketamine acts on CRPS pain, there does seem to be a dose/duration effect in that longer doses at levels tolerated by patients seem to prove more effective in terms of the duration of effects.

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So what could be happening in the brain and what is required to alter brain systems and reverse the symptomatic state? Ketamine may diminish glutamate transmission and “resets” brain circuits, but it seems that a minimal dose and/or duration of treatment is required. Alternatively, ketamine may produce neurotoxicity and damage or produce a chemical lesion of affected neurons. These two issues are important to be understood in future trials. Reports from patients who have had anesthetic doses have included prolonged pain relief for many months. While the authors did not address issues such as the effect of dosing duration or repetitive dosing at say 6weeks, they did show a level of efficacy based on NNT that equals or betters most drug trials for this condition.”

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Conclusions

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As a community we have a major opportunity to define the efficacy and use of a drug that may offer more to CRPS (and perhaps other) patients than is currently available. This is clearly an opportunity that needs urgent attention and a number of questions remain to be answered. For example, is ketamine more effective in early stage disease? How does ketamine provide long-term effects? Further controlled trials evaluating dose, duration, anesthetic vs. non-anesthetic dosing are needed. Few of us really understand what it is like to suffer from a chronic pain condition such as CRPS. Ketamine therapy may be a way forward that can be brought into our clinical practice through further controlled studies that will allow for appropriate standards for use in patients.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Medicine Costly, Where’s the Gain?


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It’s been seven years since starting this blog April 2009.

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To find information:

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  1. SEARCH – small rectangle, top left above my photo

  2. TAGS – size indicates frequency the topic was posted, bottom left narrow column

     

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Sorry there’s no time to make the site easier for you to find your way around.

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I hope you all have a good summer. Get some much needed rest.

 

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It has been a blessing to have this resource as a way to structure and teach myself the many research publications and ideas I come across in Pain Management, Neurology, Integrative Medicine, Neuroimmunology and, yes, maybe politics of medicine. I only wish I had had this tool decades ago so that I didn’t have to recreate the ones I’ve already reviewed and forgotten in the last 41 years, long before MRI scans and decades before computers in daily medicine. Now we all risk carpal tunnel from repetitive injury, which is why I need to stop posting for awhile.

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This great experience and months of effort has rewarded me, bringing me in touch with the RSD Organization, device manufacturers, editors, publishers, academics, CEO’s, scientists, physicians and patients from around the world. Thank you all!

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The politics of the world is spinning fast, harsh winds are blowing, prices of drugs are beyond belief, beyond beyond — $50,000 to $100,000 a year for new drugs. My own colleagues cannot afford $5,000 insurance deductible for visits and medication. If you are diagnosed with cancer, pray it is January before your $5,000 or $10,000 deductible comes up again at end of year. Medical care in this country is in a down spiral, affordable to the few.

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Until I see something exciting to write about, I’m over and out. What more is there to say?

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Give us some hope in research for pain and major depression. Something more we can use now, something covered by healthcare insurers who seem not to cover much of anything anymore.

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Many insurance companies have not updated reimbursement rates for some specialties for 10 or 20 years. The specialties that had the highest percentage of doctors who accept insurance are cardiology, oncology and orthopedic surgery.

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Only 55% of psychiatrists accept insurance. How sad is that? When people need Mental Health Care more than ever, what do they do but in desperation, some turn to drugs, self treating, while the $3 trillion dollar war on drugs has created and perpetuates the spiral of addiction and endless funding that only serves to enrich the military prison industrial complex.

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War does not work. Medical care works. Instead of war on drugs, war on addiction, we need medical care not war. Medical care for addiction, medical care to prevent pain, to prevent and support mental illness, to prevent addiction.

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While setting writing aside, I shall enjoy turning more of my attention to my patients. It is a privilege to work with so many fine people, striving to put disabling conditions into remission.

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If you find exciting news, please post news below.

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I wish you all a wonderful summer – get some time out!

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For those with CRPS RSD, note a new comment on this site, this past week, on Neridronic Acid.

It was posted in an unrelated section at bottom on my home page.

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Welcome to my Weblog on Pain Management!

 

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This site is not for email or medical advice.

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It is not legal for me to give medical advice

unless you are my patient

which means I have done a medical history and examination.

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I generally accept only those

who have failed most or all known treatments,

and only those who I feel I can help.

 

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I interview each patient before accepting.

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Any advertising below is not recommended or condoned by me.

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CRPS – Appendicitis treated with antibiotics can avoid surgery


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For someone who has CRPS/RSD, any trauma including surgery can severely flare CRPS and/or cause it to spread.

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A young man in his mid 20’s was headed for surgery for acute appendicitis last night. He is resolving now, 24 hours later, with IV antibiotics as I suggested. He’s the first in his hospital, a major hospital in Los Angeles.

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Dad called me last night. Mom texted me reports of CT abdomen showing thickened wall of appendix, and all labs consistent with acute bacterial appendicitis: WBC’s elevated 15.1, elevated neutrophils consistent with bacteria rather than virus. Overnight, his generalized abdominal pain is now focal and much reduced, WBC’s are ~8, well within normal range including neutrophils, and he took a good walk in hospital. By day two, WBC count was 5, normal, no elevation in neutrophils indicating brisk response to antibiotics knocking out bacteria. He’ll go home on oral antibiotics probably tomorrow. I asked and was told he has chronic constipation which begs the question if it can trigger infection because of sluggish gut.

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Treatment & References

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1. If you have CRPS, then before any procedure small, large or dental, begin minocycline, a glial modulator. It was found in animal research many years ago to prevent flare or spread of CRPS.

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2. Antibiotics IV for the bowel.

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Below is a list of articles, most from the outstanding library of the Reflex Sympathetic Dystrophy Association. Their vast collection of publications is organized by subject. I strongly recommend donating to them.

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Minocycline inhibits microglia activation and alters spinal Endocannabinoids

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Minocycline Neuroprotective- Johns Hopkins 2010 Archives of Neurology

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CRPS prolonged remission obtained by treatment of intestinal bacterial overgrowth. A multicenter study from Washington University in St. Louis, Stanford, Brown University.

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Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. One year prospective study from Nationwide Children’s Hospital, Columbus, Ohio, JAMA December 2016. IV Antibiotics for at least one day followed by 10 days of oral antibiotics.

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“Conclusions and Relevance  When chosen by the family, nonoperative management is an effective treatment strategy for children with uncomplicated acute appendicitis, incurring less morbidity and lower costs than surgery.”

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Antibiotics alone can be a safe, effective treatment for children with appendicitis. An article from Science Daily about the Nationwide Children’s Hospital study.

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“Families who choose to treat their child’s appendicitis with antibiotics, even those who ended up with an appendectomy because the antibiotics didn’t work, have expressed that for them it was worth it to try antibiotics to avoid surgery,” said Peter C. Minneci, MD, one of the authors.

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The appendix may be an important reservoir of bacteria to populate the gut with good bugs, our healthy microbiome.

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Why don’t we see appendicitis more often in adults?

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Surgery has very real potential dangers that may include infection, abscess, pulmonary emboli, cardiac arrythmias, brain damage from loss of oxygen, death. Years later, there may be chronic abdominal pain from scarring, adhesions of bowel, leading to more surgery to lyse the adhesions. Or acute pain from infarcted bowel when needed oxygen gets choked by adhesions that cause necrosis of segments of bowel, intense pain or perforation, possible death.

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Specific to laparoscopic surgery, I have seen two patients who developed years of intractable abdominal pain from the scope itself and in 2015 there was a recall of scopes across the country that caused death and/or antibiotic resistant infections carried on segments of the scope that could not be sterilized. Another concern, during laparoscopic surgery, they blow up the abdomen under very high pressures to float the organs away from the scope. Very high pressure.

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 Constipation

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Let’s see a study to determine how often chronic constipation is present for years potentially causing the appendix to become inflamed. This young man will be taking a stool softener such as DSS or Colace (same thing), and if that doesn’t work then a prescription for Amitiza is something to consider.

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There are 70,000 surgeries for appendicitis each year in children, usually teens, more often in males. In many cases the appendage is normal and surgery unnecessary.

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Antibiotics for uncomplicated appendicitis could save lives, prevent acute and long term complications, and lower healthcare costs.

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Immune cells make appendix ‘silent hero’ of digestive health

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November 30, 2015. . .Innate lymphoid cells (ILCs) are crucial for protecting against bacterial infection in people with compromised immune systems, report investigators. Their work shows that a network of immune cells helps the appendix to play a pivotal role in maintaining health of the digestive system, supporting the theory that the appendix isn’t redundant.
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The research team, a collaborative partnership between the groups of Professor Gabrielle Belz of Melbourne’s Walter and Eliza Hall Institute, and Professor Eric Vivier at the Centre d’Immunologie de Marseille-Luminy, France, found that innate lymphoid cells (ILCs) are crucial for protecting against bacterial infection in people with compromised immune systems.

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By preventing significant damage and inflammation of the appendix during a bacterial attack, ILCs safeguard the organ and help it to perform an important function in the body, as a natural reservoir for ‘good’ bacteria. The research is published in today’s issue of Nature Immunology.

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Professor Gabrielle Belz, a laboratory head in the institute’s Molecular Immunology division, said the study’s findings show that the appendix deserves more credit than it has historically been given.

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“Popular belief tells us the appendix is a liability,” she said. “Its removal is one of the most common surgical procedures in Australia, with more than 70,000 operations each year. However, we may wish to rethink whether the appendix is so irrelevant for our health.

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“We’ve found that ILCs may help the appendix to potentially reseed ‘good’ bacteria within the microbiome — or community of bacteria — in the body. A balanced microbiome is essential for recovery from bacterial threats to gut health, such as food poisoning.”

Professor Belz said having a healthy appendix might even save people from having to stomach more extreme options for repopulating — or ‘balancing out’ — their microbiomes.

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“In certain cases, people require reseeding of their intestines with healthy bacteria by faecal transplant — a process where intestinal bacteria is transplanted to a sick person from a healthy individual,” Professor Belz said. “Our research suggests ILCs may be able to play this important part in maintaining the integrity of the appendix.

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“We found ILCs are part of a multi-layered protective armoury of immune cells that exist in healthy individuals. So even when one layer is depleted, the body has ‘back ups’ that can fight the infection.

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“In people who have compromised immune systems — such as people undergoing cancer treatment — these cells are vital for fighting bacterial infections in the gastrointestinal system. This is particularly important because ILCs are able to survive in the gut even during these treatments, which typically wipe out other immune cells.”

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Professor Belz has previously shown that diet, such as the proteins in leafy green vegetables, could help produce ILCs. “ILCs are also known to play a role in allergic diseases, such as asthma; inflammatory bowel disease; and psoriasis,” she said. “So it is vital that we better understand their role in the intestine and how we might manipulate this population to treat disease, or promote better health.”

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This site is not for email.

If any questions, please schedule an appointment with my office.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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For My Home Page, click here: 

Welcome to my Weblog on Pain Management!

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NOT advocated by me and NOT approved by me.

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Norway Prioritizes Healthcare for Pain – A Note on Cosmetic Breast Surgery


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Hello Norway! I need an emoji to smile welcome!

Population 5 million – therefore data on pain can be obtained

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534 readers on these pages from Norway in the four years since 2012 got me curious.

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Norway Institute of Public Health is charged to prioritize healthcare for pain.

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Impressive! Very smart.

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“Chronic pain affects about 30 per cent of the adult Norwegian population.”

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In Denmark, “chronic pain patients had four to five times 

more in-patient days in hospital than the general population.”

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Cosmetic breast implants one in five have nerve pain for life.

Implants must be replaced every 10 to 15 years.

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Surprise note from Irish physician on Norway- see below.

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Pain is the most common reason people see a physician. Pain is the most common cause of long term sick leave and disability in Norway, and likely in every first world country. Without doubt every investment in returning people to productive health relieves the burden on the entire country.

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The most common method of treatment is analgesic drugs, and, I would add, the most cost effective.

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Pain is more common in females than males. Cosmetic breast surgery is the most common gift to girls for high school graduation in America. It was of interest to find Norway’s statistics on that:

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In a Norwegian study of young, healthy women who had cosmetic breast surgery, 13 per cent reported spontaneous pain and 20 per cent reported pain when touched one year after surgery (23).” Ahhhh, but implants are a lifetime commitment and depending on style, must be replaced every 10 to 15 years.  Is pain compounded with each overlapping surgery? Scarring? Use of arms? What further issues arise once these women require breast cancer treatment? We know that after breast cancer treatment, chronic neuropathic pain affects between 20% and 50% of women. Obesity has been linked to chronic neuropathic pain developing after breast cancer surgery.


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. 13 per cent had pain after surgery

20 per cent one year later

7 per cent more than they did immediately following surgery –

Is risk compounded when replaced every 10 to 15 years for the next 70 years?

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One in five, 20 per cent with chronic lifelong nerve pain!

Insanity

How can they know? Show them prior to surgery.

 Informed consent: view a video interview of girls who developed nerve pain.

Can it be prevented? Or treat early?

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This is neuropathic pain, the hardest to treat. Miserable.

Light touch elicits intense pain.

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We all routinely underestimate risk of surgery. For true informed consent, it would be essential to show a video interview of girls with postoperative neuropathic pain, explaining the financial cost of chronic neuropathic pain the rest of their lives, how it affects use of the arms and ability to work, how many times they must see an MD every year for pills, how it may get worse over time, what type of pills are required – this educates the surgeons too on how to diagnose and treat nerve pain with sequellae of depression, anxiety, insomnia, and how it affects everyone in their family. Everyone suffers. Many are disabled and agitated by this intense nerve pain.

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How does stress and fear affect risk of cancer and other serious medical diseases?

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We know with rodents, from John Liebeskind’s research with an Israeli team at UCLA in the mid 70’s, pain profoundly increases spread of cancer resulting in quicker death from metastases. Pain kills. He lectured nationwide on this. I posted on his message just weeks ago, December 27. “Pain kills. A malefic force.”  “…pain can accelerate the growth of tumors and increase mortality after tumor challenge.”

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John C. Liebeskind, 1935 – 1997, distinguished scholar and researcher, past president of the American Pain Society, had the radical idea that pain can affect your health.

 

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Twenty percent! Girls don’t know. How could they?

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Does cosmetic breast enlargement at such young age

increase

potential risk of  tumorigenesis, invasiveness, metastasis?

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Trauma (surgery) activates microglia lifelong. Glia never return to baseline.

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Microglia produce inflammatory cytokines –  inflammation.

Inflammation underlies almost all known disease.

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Does breast surgery, any surgery, increase risk of other known disease?

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What does inflammation do to endometriosis and autoimmune risks in this population?

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These are purely speculative thoughts. We cannot know until it is studied longitudinally and prospectively – if ever. Large breasts are very trendy. Obesity is very common; alas it is also pro-inflammatory.

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Postsurgical sequaellae can be extremely challenging. I will try to post two case reports in the near future. They are complex, enlightening, tangled, difficult to diagnose, post-surgical cases. The senior chief of surgery at Mayo Clinic had only seen two prior cases like it in this man who had laparoscopic prostate surgery many years before. Surgical sequaellae cannot be predicted. Large scale surgery in girls for cosmetic reasons have unexpected consequences. What is their cost decades from now?

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Norway Institute of Public Health has very nice data on drugs used, graphed vs time for men and women.  

 

Chronic pain in children and adolescents

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The incidence of chronic pain in children and adolescents is poorly mapped in Norway, but the consumption of analgesics and figures from other countries suggest that chronic pain is also common in adolescence (8). In the Health Interview Survey of 2005, parents reported that 6 per cent of children aged 6-10 years and 12 per cent of adolescents aged 11-15 years had chronic pain symptoms.

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A study of 12-15 year olds in South and North Trøndelag shows that 17 per cent suffered regularly from headaches, abdominal pain, back pain or pain in arms / legs (9). Consumption of analgesic drugs among Norwegian 15-16 year olds is high and has risen considerably since 2001 (10).

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Treatment

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Pain is probably the most common reason for patients to seek health care (26). A Swedish study found that 28 per cent of patients in general practice had one or more medically-defined pain conditions (27) – (my patients have at least 3 or 4). Corresponding figures are found in Denmark (28), where it has also been shown that chronic pain patients had four to five times more in-patient days in hospital than the general population (29). Corresponding figures for Norwegian conditions are unavailable.

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Irish physician comments on Norway

just minutes before writing about Norway! sweet coincidence. He posted on a case report I wrote in 2010 on Complex Regional Pain Syndrome (CRPS) and low dose naltrexone, (LDN).

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Dr Edmond O`Flaherty

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I am a primary care physician in Ireland. I have been prescribing LDN for 9 years and it has utterly changed the lives of hundreds of people. The main conditions I see are fibromyalgia, chronic pain, MS, various cancers, Crohns/UC, chronic fatigue/ME, several other auto-immune diseases and one case of Interstitial Cystitis where a 30-year woman had “a fire in her bladder 24 hours a day” and who was due to have a cystectomy (bladder replaced by a plastic bag!) a month later than when she came to me by chance and soon became well.

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TV2 in Norway made a film about LDN in 2013 which was seen by 10 % of the population. The number using it there went from 300 to 15,000 in a few months. It is now on the website of http://www.lowdosenaltrexone.org in America and I was the only doctor outside Norway who was involved. I agreed to partake if they subtitled it in English which they did.

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.Yes

Yes. Opioids cause pain. Naltexone relieves, and often resolves pain.

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My comment:

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Based on the work posted on these pages, RSDS.org sent scientists and specialists to my office in 2010. Over two days I introduced them to eight of my patients with years of intractable chronic pain, all of whom responded to low dose naltrexone, four of whom required treatment only one month with sustained pain relief   for years! RSDS is now funding a study on LDN for CRPS at Stanford.

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Norway has well known large cities, UNESCO heritage sites and this absolutely gorgeous small seaport village Reine on an island in the Lofoten archipelago, above the Arctic Circle. It was “selected as the most beautiful village in Norway by the largest weekly magazine in Norway (Allers) in the late 1970’s” and is visited by many thousands annually. “Lofoten is known for a distinctive scenery with dramatic mountains and peaks, open sea and sheltered bays, beaches and untouched lands. Though lying within the Arctic Circle, the archipelago experiences one of the world’s largest elevated temperature anomalies relative to its high latitude. Lowest temperature ranges from 28.4 to 35.6 degrees F.  The warmest recording in Svolvær is 30.4 °C (87 °F).

 

 

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Sequoia wildflower

 

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The material on this site is for informational purposes only.

It is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

Relevant comments are welcome.

If any questions, please call the office to schedule an appointment.

This site is not email for personal questions.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please be aware any advertising on this free website is

NOT advocated by me and NOT approved by me.

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Be the change you wish to see – or walk away. Money at NIH


 

 

A Turning Point

 

$$$$$ MONEY $$$$$

 

at NIH

 

May not come this way again

 

NIH developing

5-year NIH-wide Strategic Plan

 

 

 

Donate to organizations, below

They can provide feedback to NIH via the

RFI Submission site


 

 

 

John C. Liebeskind, 1935 – 1997, distinguished scholar and researcher, past president of the American Pain Society, had the radical idea that pain can affect your health.

 

Research decades ago by an Israeli team at UCLA and others had shown “that pain can accelerate the growth of tumors and increase mortality after tumor challenge.” Decades ago Professor Liebeskind lectured all over the country: Pain kills.

 

He wrote an editorial in 1991, summarizing a life’s work:

 

“Pain and stress can inhibit immune function.”

 

 

Quoting John Bonica, the father of modern pain management, he wrote:

 

“Bonica has long argued that the term ‘chronic benign pain’ (used in distinction to pain associated with cancer) is seriously misleading.  Chronic pain is never benign, he contends; “it is a ‘malefic force’ that can devastate its victims’ lives and even lead to suicide.”

 

 

Liebeskind continues, “It appears that the dictum ‘pain does not kill,’ sometimes invoked to justify ignoring pain complaints, may be dangerously wrong.”

 

Pain mediates immune function

 

Importantly

 

  Opioids mediate the suppressive effect of stress on natural killer cells,

 

 published in 1984, immune system.

 

Alcohol increases tumor progression, 1992, immune system.

 

It used to be news.

He did not live to see change.

 

People just want to go on doing what they’re doing.

They want business as usual.

 

 

After 1991, we saw the great discoveries of neuroinflammation, pioneered by Linda Watkins, PhD, the early understanding of the innate immune system, its involvement in chronic pain and depression, and a few weeks ago, a British team showed neuroinflammation in teens with early signs of schizophrenia and DNA markers.

 

 

Major Depression has the same neuro-inflammation found in chronic pain, often responding to same medications, in particular glial modulators – immune modulators. Now, perhaps early schizophrenia will respond to glial modulators, reducing inflammation seen on scan in teens, before they become homeless and burned out by antipsychotic drugs

 

Inflammation out of control destroys neurons

 

Fire on the brain

 

 

We must be the change we wish to see

 

It’s not just the Bern. It’s been starting. Forces are finally coming together. We want change. It’s been too much. Too long.

 

We won’t take it anymore.

 

I figure if I tell you about it, you might just mention it to someone to pass it on. That is all. One small action may lead to change. Activate inputs to the NIH strategic plan.

 

 

~ Action needed ~

 

Prices of drugs becoming unaffordable

No new drugs for pain or major depression

Research to repurpose existing drugs

Expose the politics destroying our compounding pharmacies

 

Above all

The #1

Major Priority:

Request NIH to solicit priority call for research on

Glial modulators of the

Innate immune system

 

 

Why?

 

Glia modulate

chronic pain, major depression

and almost every known disease

 

Glia are your innate immune system

 

Inflammation kills

 

 

 

 Stress kills. Inflammation kills.

 

 

Pain kills

 

In the 1970’s, Professor Liebeskind and an Israeli team at UCLA injected cancer cells to two groups of rats that had sham surgery. Cancer spread much faster and killed far sooner in the group with poor treatment of surgical pain.

 

 

~ Pain kills ~

 

He lectured all over the country

 

Forty five years ago

 

 

I’m gonna be dead before I see this country do anything but unaffordable opioids and the magical ineffective trio of gabapentin, Lyrica, Cymbalta to treat chronic pain. The devastating, blind, nationwide emphasis does nothing to address the cause: inflammation, the innate immune system gone wild.


 

 

Innate immune system in action

 

Untreated pain suppresses the hormone systems too.

 

Untreated depression – same inflammation kills lives.

 

Where’s the money?

 

We are the change we wish to see. It’s pitiful I am so lazy. Suddenly, too late, we may need something, but, aha, no new drugs in the pipeline.

 

 

 

~ Make a joyful cry to NIH ~

 

They are soliciting input from professional societies

 

If your condition has failed all known drugs for pain or major depression, then make a joyful cry to NIH, now, before they give away all that nice new $$$$$money$$$$$.

 

 

Follow and join

 

American Pain Society

 

 

International Association for Pain

celebrating 40 years of pain research

 

 

Reflex Sympathetic Dystrophy Syndrome Association

help for CRPS/RSD  

 

 

 

The key to CRPS/RSD pain will apply to all forms of chronic pain, in particular the most difficult form, neuropathic pain. RSDSA funds research into all forms of chronic pain, not only Complex Regional Pain Syndrome (CRPS/RSD). Their scientific board members are not funded by opioid money.

 

 

 

Exactly

what is the annual cost of care

as fraction of GDP

for the growing population of Americans on opioids

for one year, for lifetime?

 

 

People are dying from prescription opioids and those who need them find they don’t work well enough. Prescriptions opioid costs must be a huge fraction of the medical costs in the United States GDP. You are required  to see a doctor every single month each year, often lifelong, just for one opioid, 12 months a year x 30 years x tens of millions of people and increasing – a growth industry. Not even counting $600 a day for the opioid, what the cost of monthly visits for 30 years? Not counting the army of DEA, FDA, CDC agents watching the opioids like a hawk. We all have to be sharp, addiction is growing. Addiction aside, deaths from prescription opioids are shaking up the CDC forcing urgent change this coming month.

 

 

 

Opioids do not work well for chronic pain

We need better

It’s not just the $600/day price

They just don’t work

 

 

donate

 

 

Raise a joyful noise at NIH now or write back at us readers with comments and better suggestions. Tell others what you’d like to see. Which politicians do you know would be most interested in this at national levels and organizations?

 

You may never see this change unless you do it now. Other forces will get this new money.

 

 

Turning point now

May not return

 

 

We are at a turning point and we will fail to catch the sail that’s coming fast to carry all research money in their shiny big stem cell direction. They never look back.

 

 

There is so many medications we can use today, FDA approved drugs that can be re-purposed and applied to recent cutting edge science. Someone must pay to do the work to study this.

 

 

Re-purpose old drugs

 

 

Stanford just showed a popular generic drug improved recovery of stroke paralysis in mice to begin at 3 days rather than 30. Old drug, new purpose, of course more years of testing to confirm in humans. Brilliant team applying new science.

 

 

Request
NIH to solicit a

Special Invitation

for 30 good protocols to

repurpose old drugs

 

 

Hundreds of old drugs, already approved, could be involved in mechanisms we have recently learned about. Speak up or money will go to shiny new stem cells. None for chronic pain or major depression. No company will find this profitable – it must be funded by NIH. A popular generic sleeping pill can bring astonishing return from stroke paralysis.

 

 

Congress has not opened this new money to NIH in many long years. How often will there be extra money?

 

 

donate

 

 

Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director, NIH, solicits you to

Review the NIH Strategic Initiative Plan and their

Request for Information (RFI) and the NIH website

and provide your feedback via the RFI Submission site

 

 

This is for “stakeholder organizations (e.g., patient advocacy groups, professional societies) to submit a single response reflective of the views of the organization/membership as a whole. We also will be hosting webinars to gather additional input. These webinars will be held in early to mid-August.

 

 

 

Be the change you wish to see

Donate to those organizations

to solicit the change you wish to be

 

 

 

Happy New Year

Rejoice!

There’s money at NIH

 

 

 

 

 

 

The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

Relevant comments are welcome.

If any questions, please schedule an appointment with my office.

This site is not for email.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

 

 

 

 

Analgesic Response to Ketamine Linked to Circulating microRNA in Complex Regional Pain Syndrome


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Analgesic Response to Intravenous Ketamine

Is Linked to a Circulating microRNA Signature

in Female Patients

With Complex Regional Pain Syndrome

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The ability to measure Micro RNS’s (miRNA) in blood looks like it may become an important tool someday once it is available for the clinic. It could be used to predict if your condition will respond to various medications.

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MicroRNAs are emerging as important modulators of various psychiatric (schizophrenia, bipolar disorder) and neurological conditions including pain, epilepsy, cognitive dysfunction, neuronal development, structure and function. “MicroRNAs are small, non-coding RNAs that act as post-transcriptional regulators of gene expression.  miRNA’s can be affected by morphine and affected by other drugs. It is hoped that complex clinical phenotypes may be profiled in assays of peripheral blood and may predict response to treatment such as in this study. Ketamine is given for selected patients that have failed to respond to standard treatment.

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This research was published in Pain, June 2015, by Professor Schwartzman’s group at Drexel University. Seven of his patients with Complex Regional Pain Syndrome were ketamine responders and 6 were poor responders. They note that, “Although [ketamine] treatment is generally effective, approximately 30% of patients have an inadequate response to ketamine.”

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“Stability in circulation and dysregulation in disease state are 2 features making extracellular miRNAs useful candidates for biomarker discovery. Alterations in miRNA profiles have been reported for rheumatoid arthritis and systemic lupus erythematosus as well as for painful conditions such as irritable bowel syndrome, chronic bladder syndrome, endometriosis, and migraine. Cerebrospinal fluid from patients with fibromyalgia showed differential expression of 9 miRNAs.”

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Quoting directly from the article:

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Highlights

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•We studied ketamine treatment–induced miRNA alterations in blood from patients with CRPS.
•Differential miRNA expression was observed in whole blood before and after treatment.
•Before therapy, 33 miRNAs differed between responders and poor responders.
•Lower pretreatment levels of miR-548d-5p may contribute to higher UDP-GT activity.
•Circulating miRNAs can be potential biomarkers in predicting treatment response.

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From the Abstract

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Investigation of the mechanistic significance of hsa-miR-548d-5p downregulation in poor responders showed that this miRNA can downregulate UDP-glucuronosyltransferase UGT1A1 mRNA. Poor responders had a higher conjugated/unconjugated bilirubin ratio, indicating increased UGT1A1 activity. We propose that lower pretreatment levels of miR-548d-5p may result in higher UDP-GT activity, leading to higher levels of inactive glucuronide conjugates, thereby minimizing the therapeutic efficacy of ketamine in poor responders.

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Perspective

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This study suggests the usefulness of circulating miRNAs as potential biomarkers. Assessing miRNA signatures before and after treatment demonstrated miRNA alterations from therapy; differences in miRNA signature in responders and poor responders before therapy indicate prognostic value. Mechanistic studies on altered miRNAs can provide new insights on disease.

 

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From the Discussion

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Ketamine is also considered to be the prototype for a new generation of glutamate- based antidepressants that can alleviate depression within hours of treatment. Several biological measures have been explored to characterize treatment response and to gain insight into mechanisms underlying the rapid antidepressant effects of ketamine. A plasma metabolomics study in patients with bipolar depression suggested that the basal mitochondrial b-oxidation of fatty acids differed between responders and nonresponders to ketamine. Other studies have shown differences in baseline plasma concentrations of D-serine, serum levels of interleukin 6, and plasma levels of Shank3, a postsynaptic density protein involved in NMDA receptor tethering and dendritic spine rearrangement.

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Differences in the ability to metabolize ketamine because of interindividual differences and pharmacogenetic factors have been proposed to contribute to the varied responses to ketamine therapy and its clinical outcome. Similar conclusions have been drawn for patients with depression; plasma from patients with treatment- resistant bipolar depression who had undergone a single 40-minute infusion of a subanesthetic dose of ketamine showed that although NK is an initial metabolite, it is not the major circulating metabolite. This again suggests that other downstream metabolites of ketamine may play a role in the pharmacological effects of the drug. It is also known that (2S,6S)-hydroxynorketamine is an active and selective inhibitor of the a7 subtype of the nicotinic acetylcholine receptor; this activity was shown to contribute to the pharmacological responses associated with the antidepressant activity of (R,S)-ketamine. We postulate that in patients with CRPS, 1 factor contributing to resistance is an altered pharmacokinetic profile produced by enhanced elimination of active metabolites downstream of NK, which is mediated by hsa-miR-548d-5p. However, because we have relied on indirect evidence of a higher percentage of direct/indirect bilirubin in poor responders, indicating increased UDP-GT enzyme activity, additional studies investigating hydroxynorketamine and its downstream metabolites along with their glucuronide conjugates in plasma and urine will provide direct evidence for the role of miR-548d-5p in mediating response to ketamine therapy in responders and poor responders.

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They noted a significant difference in body weight between responders and nonresponders (heavier), but not in duration of disease and analgesic response to ketamine. Toward that end, they will publish separately upon

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… investigating the link between miR-34a, which showed 28-fold reduction in poor responders relative to responders (Table 2), and the neuroendocrine system….

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From the Conclusion

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Our studies showed that miR-548d-5p can regulate UDP-GT but not CYP3A4, suggesting that UDP-GT activity in responders and poor responders may be mediated by differences in the level of circulating miR-548d-5p. Lower levels of miR-548d-5p in poor responders before treatment could result in higher UDP-GT activity, leading to the production of more inactive glucuronide conjugates and faster elimination of active ketamine metabolites downstream of NK. Thus, the levels of hsa-miR-548d-5p could minimize the therapeutic efficacy of ketamine and pain relief. Differences in miRNA signature can thus provide molecular insights distinguishing responders from poor responders. High failure rates of drugs targeted to treat neuropathic pain warrant changes in approaches. Studies targeting well-defined patient populations for clinical trials will play a crucial in developing drugs that may be efficacious in a subset of patients. Extending this approach to other treatment and outcome assessments might permit stratification of patients for maximal therapeutic outcome.

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How frustrating it is for patients and family who must cope with an intractable condition such as pain or Bipolar Disorder or treatment resistant Major Depression that has failed all commonly prescribed medications. For all of them, we need changes in approach.

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“High failure rates of drugs targeted

to treat neuropathic pain

warrant changes in approaches.”

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Perhaps scientists reading this would comment upon how it may relate to tolerance as it differentially occurs in those receiving intermittent ketamine vs continuous intravenous infusion.

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Dysregulation of miRNA’s has been shown in psychiatric disorders including depression and schozophrenia, neurodevelopmental disorders, cognitive dysfunction,  epilepsy, chronic pain states with implication for the cause and treatment of these disorders.

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Research targeting miRNA’s as novel treatment for depression has shown that chronic fluoxetine, repeated electroconvulsive shock therapy, and acute ketamine have the capacity to alter hippocampal miRNA levels.

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It is hoped these tests may be available someday clinically as the cost of off-label treatment not covered by insurance is a great burden for those already disabled by intractable pain or treatment resistant depression.

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PUBLIC WARNING

warning reprinted with permission of Demitri Papolos, MD
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Ketamine is a controlled substance.
Administered improperly, or without the guidance of a qualified doctor,
Ketamine may cause injury or death.
No attempt should be made to use Ketamine
in the absence of counsel from a qualified doctor.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please ignore the ads below. They are not from me.

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Bisphosphonate – Pamidronate – Safety Summary – For Serious Pain from CRPS


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Bisphosphonates for Complex Regional Pain Syndrome?

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If you have Complex Regional Pain Syndrome and you have severe pain that has failed all remedies, you may wish to consider bisphosphonate infusions for pain relief. This area needs more research – there is almost none, only three or four small publications on pamidronate for chronic noncancer pain that I posted here.

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Those posts on bisphosphonates in the last two weeks have developed the background to the use of bisphonates for chronic noncancer pain. This is not everyday medicine for pain control, but it is common for certain cancers and for osteoporosis.

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There is a science behind this choice. There is a strong rationale, it makes sense, but this is serious therapy.

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We do not know if it will work or how many may benefit.

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To my knowledge, it has not been done outside of those three or four very small studies. No one is offering this therapy for CRPS. But we all see patients who have tried and failed every known therapy that exists, and pain has taken their lives.

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Here we review these specific points:

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-Safety

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-How soon you can consider pregnancy after treatment?

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-Side effects with the infusion

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-Calcium supplements you need to take

 

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Information has been taken from the award winning website of Susan Ott, Professor of Medicine at University of Washington and an expert on bisphosphonates and metabolic bone disease. Her teaching goes beyond what can be gleaned from publications, and thankfully spans the depth of the field. It is a concise encyclopedia of bisphosphonates for physicians and patients. Apologies to Professor Ott, I have quoted her work liberally.

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SAFETY

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Safety issues are discussed in this editorial Long Term Safety of Bisphosphonates by Professor Ott.

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“Unlike most medications, bisphosphonates remain in the body for decades. These drugs are not metabolized….The amount of drug within the bone will accumulate with use. There is no known method of removing the medication from the bones. The duration of physiological effect is still unknown.”

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Further, she notes the reduced risk of fracture is not closely linked to the increase in bone density. Fracture rate was higher with increased density. E.g., hip fracture decreased with 2.5 mg/d risedronate relative to placebo, but 5.0 mg/d was same as placebo.

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The issue:

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As bone mineralization increases, bone becomes more brittle.

Brittle bone may be more susceptible to fracture.

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PREGNANCY

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It is recommended that you not become pregnant while bisphosphonate is in your bones.

It is contraindicated in women who are pregnant or planning pregnancy.

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Her advice: wait at least one year after stopping the medication to try getting pregnant. The drugs are still excreted in the urine 8 years after stopping.

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Women who are pregnant should not take bisphosphonates. If women are already taking a bisphosphonate and want to become pregnant, it is not clear how long they should wait [my emphasis]. Until more information is available, I suggest waiting at least one year after stopping the medication to try getting pregnant. If a woman is taking a bisphosphonate and inadvertantly gets pregnant and wants to continue the pregnancy, she should be carefully followed, with measurements of calcium and optimal vitamin D levels. Calcitonin is a safe drug to use during pregnancy if bone loss is a concern.

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See below, for more details on toxicity studies in pregnancy.

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SIDE EFFECTS AFTER THE INFUSION

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The day after the infusion it is common to have a fever. Some patients feel like they are getting the flu and feel aching and tired. This usually lasts only one or two days. You may have pain in the bone, especially if you have Paget’s disease or fibrous dysplasia. Other complications are not common, and include a transient decrease in the white blood cell count or blood calcium. The infusion site may become sore or infected. Rare side effects are inflammation of the eyes, kidney damage, or problems with the bones underneath the teeth.

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To be safe, the following blood tests should be normal before giving pamidronate: calcium (greater than 9.0 mg/dl) creatinine, white blood cell count, vitamin D (at least 20 ng/ml). It should not be given during an active infection.

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More detailed studies of blood that I do will also include post infusion study of urine for urinary cross-linked N-terminal telopeptides of type I collagen (NTX).

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CALCIUM SUPPLEMENTS – WHICH ONES?

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Patients need to be sure to get adequate calcium and vitamin D after pamidronate infusions.

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Professor Ott recommends specific calcium supplements — not all are equal. “Many brands do not dissolve in the intestines, so the calcium is not absorbed into the bloodstream.”

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She lists these brands to take, with photos and cost in order of price:

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TUMS EX – least expensive, Caltrate, Oscal, Viactiv, Citracal – most expensive

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Calcium carbonate should be taken with food. Calcium citrate can be taken on empty stomach. Take twice daily. Do not get calcium with magnesium – magnesium may compete with calcium, i.e. block it.

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TOXICITY STUDIES

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Effects of bisphosphonates during pregnancy. Bisphosphonates should be avoided during pregnancy. Refer to her summary for details of animal toxicity studies and human studies.

 

Here is a copy of the 2004 FDA label information for pamidronate:
Pregnancy Category D (See WARNINGS)

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There are no adequate and well-controlled studies in pregnant women.
Bolus intravenous studies conducted in rats and rabbits determined that Aredia produces maternal toxicity and embryo/fetal effects when given during organogenesis at doses of 0.6 to 8.3 times the highest recommended human dose for a single intravenous infusion. As it has been shown that Aredia can cross the placenta in rats and has produced marked maternal and nonteratogenic embryo/fetal effects in rats and rabbits, it should not be given to women during pregnancy.

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Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. The extent of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the total dose and duration of bisphosphonate use. Although there are no data on fetal risk in humans, bisphosphonates do cause fetal harm in animals, and animal data suggest that uptake of bisphosphonates into fetal bone is greater than into maternal bone. Therefore, there is a theoretical risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been established.

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Nursing Mothers
It is not known whether Aredia is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Aredia is administered to a nursing woman.

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The material on this site is for informational purposes only, and is not a substitute for

medical advice, diagnosis or treatment provided by a qualified health care provider.

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~

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

~

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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~
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Bisphosphonates for Pain – Back Pain, CRPS Pain. Have You Received Pamidronate or Other IV Bisphosphonate for Pain?


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Bisphosphonates have been used for treatment of pain.

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I have reviewed a few studies on pamidronate infusions for pain,  below.

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Based on these small studies, there is a growing rationale for use of I.V. pamidronate in the setting of selected chronic intractable pain syndromes.

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Have you received IV Pamidronate or Reclast or any bisphosphonate

for treatment of pain caused by any condition?

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Bisphosphonates are effective for reducing bone loss and, separate from that mechanism, they have been used to reduce pain in persons with various conditions including Complex Regional Pain Syndrome, ankylosing spondylitis, rheumatoid arthritis, chronic back pain, and other conditions.

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After you vote, if you wish to see results, click on the words “View results.” You do not need to sign in or give your email. Simply view results.

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If you have any experience with bisphosphonates even if for osteoporosis, please comment below. Do you know which academic centers are giving IV bisphosphonates for pain?

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The mechanism of pain relief is not clear and there are no standardized protocols for the use of bisphosphonates for pain, but relief of pain is believed to be separate from mechanisms related to bone.

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Many patients have no other options for treatment. There are no large randomized controlled studies – where is NIH funding for pain?

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Many medical treatments do not work for some patients with Complex Regional Pain Syndrome or for chronic low back pain. When all else has failed, pamidronate may be given IV, often in a series of infusions that take up to four hours. There may be some flu-like symptoms for 1 to 3 days after.

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For reasons unknown to us, Complex Regional Pain Syndrome is often associated with bone loss in the area of pain. It is more marked and prolonged than in immobilized trauma patients.

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What dose should be used, how often should it be given? Few studies have been published.

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MEDICATIONS for OSTEOPOROSIS

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Bisphosphonate therapy is commonly used for diseases of bone such as osteoporosis or Paget’s Disease, multiple myeloma, bone metastasis, osteogenesis imperfecta, fibrous dysplasia. For example alendronate (Fosamax) or residronate (Actonel) tablets,  pamidronate infusions,  or others.  Zoledronic acid (Reclast) is given IV, usually only once each year. One form of ibandronate (Boniva) is also given IV, usually every 3 months.

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Other medications that are not bisphosphonates are used for osteoporosis such as calcitonin-salmon (Miacalcin) SC or IM injections, Forteo (rhPTH ) SC injections, or estrogen.

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MECHANISM of BISPHOSPHONATES

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Bisphosphonates slow the rate of bone loss, they do not actually build bone. Bone requires a balance of osteoblasts that form new bone, and osteoclasts that resorb bone. Osteoporosis occurs with age and especially with loss of estrogen that dramatically increases loss of bone. Other factors that lead to bone loss are lack of exercise, hormonal, nutritional and genetic predispositions.

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RISKS of OSTEOPOROSIS

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Some of the worst pain I have seen in my career is pain due to fractures of fragile osteoporotic bones. It may be impossible to treat. With osteoporosis, you may simply roll over in bed and 7 rib fractures occur. One woman developed hundreds of fractures throughout her pelvis and was bedridden for years after a very minor incident. Bone stimulators did not help and she could not walk or stand without help. Years later there was a 1-1/2 inch gap between the fractures in her pelvis and of course being inactive and bedridden can only make osteoporosis worse.

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RISK of MEDICATION for OSTEOPOROSIS

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Osteoporosis is more dangerous by far than any medication used to treat it. As with any drug, the benefit must outweigh side effects. Bisphosphonates increase bone thickness and reduce risk of fractures. Osteoporosis medications causes less than 1% risk of bone fractures. Fractures from the medications may be seen in the midshaft of the femur which is the mid thigh; and they may cause osteonecrosis of the TMJ, the jaw bone. Serious problems with bone healing after dental surgery may occur in those who take bisphosphonates. But the risk of osteoporosis is far greater than this small risk.

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Non-bisphosphonates also have dangers: Calcitonin may increase risk of cancer. PTH is the only one that can actually build bone – an anabolic agent that induces bone formation, not just prevent resorption of bone, but abrupt termination leads to rapid loss of bone density. Estrogen increases risk of clotting, thromboembolism that is a risk for stroke.

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Neridronate is a new bisphosphonate available so far only in Europe the last few years. They are making claims that a series of neridronate infusions can reduce pain 100% in persons with Complex Regional Pain Syndrome. That seems highly unlikely:  100% effective? Really? Oh, and so far no reports of necrosis of bone. But it has not been available as long as pamidronate, so it may be years before we get a better assessment of this drug that is confirmed by other laboratories.

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PUBLICATIONS

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Dr. Pappagallo published three of the studies below. He is one of the foremost scientist-pain specialists in the world.

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A pilot trial of intravenous pamidronate for chronic low back pain

PAIN, Volume 155, Issue 1 , Pages 108-117, January 2014,  Pappagallo et al, found no serious adverse events.

They tested four groups of 11 subjects (7 active, 4 placebo) at differing doses. They conclude:

i.v. pamidronate, administered as two 90 mg infusions four weeks apart, decreased pain intensity for 6 months in subjects with CLBP.

[Pain was decreased by > 4 points. They showed no relationship between bone density and analgesic response, but did find a relationship between PTH, vitamin D status and pain response.]

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Bisphosphonates are known to have significant analgesic activity in addition to their well-characterized role in inhibiting bone resorption. For example, pamidronate (Aredia®, Novartis), an aminobisphosphonate, demonstrates clinically significant pain relief when administered intravenously for the treatment of Paget’s disease, metastatic breast cancer and osteolytic lesions of multiple myeloma [5], [24], [51]. In addition, i.v. pamidronate has been shown to have analgesic activity in a wide variety of painful conditions, including complex regional pain syndrome [12], [44], [53], fibrous dysplasia [10], recurrent multifocal osteomyelitis [22], [35], ankylosing spondylitis [33], rheumatoid arthritis [31], and others (for review, see [49]). The mechanism(s) of this analgesic effect is not fully known, but antinociceptive effects of pamidronate and other bisphosphonates have been reported in animal models of pain [7], [8], [25], [52]. Inhibition of osteoclast proton secretion and other cellular and molecular mechanisms may contribute to the analgesic effect [37], [54].

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The molecular mechanisms of pamidronate’s analgesic effects are not fully understood. Bisphosphonates are known to inhibit the activity and/or cause apoptosis of osteoclasts [20], [46], which remodel bone by creating an acidic microenvironment via the release of protons through vacuolar H+-ATPase [6], [45]. Osteoclast-induced high concentrations of protons may activate acid-sensing ion channels and transient receptor potential vanilloid type 1 channels expressed by small nerve fibers involved in pain signal transmission [37], [42], [54]. Osteoclasts appear to have a role in inflammatory pain adjacent to bone and in the hyperalgesia observed in type IX collagen-deficient mice [2], [37]. Of interest, inhibition of osteoclasts by bisphosphonates in a rat model of degenerative joint disease has recently been found to prevent subchondral bone resorption and cartilage loss, and decrease pain [50]. Clinical findings may also suggest a role for subchondral bone changes in the early development of painful osteoarthritis [13], [36]. Furthermore, the anatomical core structure of the spine is made of bone tissue, and immunohistochemical studies have revealed the presence of a widespread network of peptidergic small sensory fibers throughout the bone marrow, mineralized bone, and periosteum [28], [32]. Thus it is conceivable that: a) nonspecific low back pain (associated with degenerative disk disease or spondylotic disease as in our study population) may be related to sensitization of bone nociceptors, plausibly in the context of subchondral bone resorption (eg, at the vertebral endplates and/or facet joints) and b) inhibition of subchondral osteoclasts (and possibly of other phagocytic or inflammatory bone resident cells) by i.v. pamidronate might be clinically relevant to the treatment of CLBP.

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The responder rate for pamidronate 180 mg increased from 50% at 24 hours after the second infusion to 100% at month 2; the 100% responder rate was maintained at all subsequent time points. [There were 7 patients in each group of this small study.]

(Fig. 3) illustrates that all subjects receiving 180 mg pamidronate had at least 50% pain relief at both 3 and 6 months postinfusion, and approximately 80% of subjects receiving 180 mg pamidronate had 100% pain relief at 6 months.

Fig. 3. Continuous responder analysis. Blue solid line, placebo; red dashed line, 30 mg pamidronate; green dashed/dotted line, 60 mg pamidronate; brown dashed line, 90 mg pamidronate; purple dashed/dotted line, 180 mg pamidronate.

 

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Pamidronate treatment in rheumatology practice: a comprehensive review

Clinical Rheumatology, Volume 28, Issue 12, pp 1359-1364, December 2009, Slobodin et al. from Israel.

The efficacy of pamidronate in patients with spondyloarthropathies; synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome; hypertrophic osteoarthropathy; osteoporotic vertebral fractures; chronic back pain due to disk disease or spinal stenosis; Charcot arthropathy; transient osteoporosis; and complex regional pain syndrome-I, has been demonstrated in more than 40 reports, the majority of which, however, were not controlled studies. In some of reviewed conditions, aside from providing analgesic relief, pamidronate may also have disease-modifying properties. While used in different doses in a variety of rheumatic disorders, pamidronate was generally reported to be well tolerated with an overall good safety profile. Pamidronate may represent an effective and safe choice for a spectrum of rheumatic patients, suffering from intractable musculoskeletal pain, unresponsive to traditionally recommended therapies. Large randomized, controlled studies examining the efficacy of pamidronate in the rheumatic conditions are urgently needed.

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Complex regional pain syndrome (CRPS/RSD) and neuropathic pain: role of intravenous bisphosphonates as analgesics. ScientificWorldJournal. 2008;8:229–236Yanow J, Pappagallo M, Pillai L.  They review multiple studies for pain of CRPS.

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Efficacy of pamidronate in complex regional pain syndrome type I. Pain Med. 2004;5:276–280, Robinson JN, Sandom J, Chapman PT from New Zealand.

Pamidronate 60 mg iv was given only one time to 14 patients, 13 placebo controls.

Overall improvements in pain score, patient’s global assessment of disease severity score, and physical function (SF-36) score were noted in the pamidronate group at 3 months, and improvements in role physical (SF-36) score were noted at 1 and 3 months. There was variability in pamidronate response among individuals. CONCLUSIONS: Pamidronate may be a useful treatment option in the management of patients with CRPS Type I. Although treatment response was variable, the majority of patients improved.

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Treatment of chronic mechanical spinal pain with intravenous pamidronate: a review of medical records. J Pain Symptom Manage. 2003;26:678–683, Pappagallo M, Breuer B, Schneider A, Sperber K.

[They] reviewed the charts of 25 patients who had experienced disabling spinal pain for several years, and whom we treated with [iv] pamidronate. None had a history of osteoporotic vertebral fractures or metastatic disease. Pain rating scores decreased in 91% of patients: on a 0–10 numeric rating scale, the mean pain change was 3.6 points and mean percentage change was 41% (P <0.0001).

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Treatment of severe, recalcitrant reflex sympathetic dystrophy: assessment of efficacy and safety of the second generation bisphosphonate pamidronate. Clin Rheumatol. 1997;16:51–56, Cortet B, et al. from France infused 14 patients 1 to 3 days, followed 3 months and in one case for 9 months. “results suggest an efficacy” and they recommended double blind placebo controlled studies.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is illegal for me to give medical advice

without seeing you in office for history and examination.

I cannot respond to your medical questions unless you schedule an evaluation.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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PEA Palmitoylethanolamide – “Glia & Mast Cells as Target, An Anti-Inflammatory & Neuroprotective Lipid Mediator”


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Another oustanding article on palmitoylethanolamide “PEA.” I have seen profound results with it relieving intractable neuropathic pain in a woman with CRPS for years, and I suspect it may help Major Depressive Disorder but that remains to be tested.

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I need to add that opioids create pain. One mechanism by which that occurs is that opioids create pro-inflammatory cytokines, which creates more pain. Patients may see no response to essential pain relieving medications untill they taper off all opioids and allow the system to stabilize. Otherwise, they will have pain forever and it may increase.

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Glia and mast cells as targets for palmitoylethanolamide,

an anti-inflammatory and neuroprotective lipid mediator

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Authors  Skaper SD, Facci L, Giusti P.

Mol Neurobiol. 2013 Oct;48(2):340-52.  Epub 2013 Jun 28.

Abstract

Glia are key players in a number of nervous system disorders. Besides releasing glial and neuronal signaling molecules directed to cellular homeostasis, glia respond also to pro-inflammatory signals released from immune-related cells, with the mast cell being of particular interest. A proposed mast cell-glia communication may open new perspectives for designing therapies to target neuroinflammation by differentially modulating activation of non-neuronal cells normally controlling neuronal sensitization-both peripherally and centrally. Mast cells and glia possess endogenous homeostatic mechanisms/molecules that can be upregulated as a result of tissue damage or stimulation of inflammatory responses. Such molecules include the N-acylethanolamines, whose principal family members are the endocannabinoid N-arachidonoylethanolamine (anandamide), and its congeners N-stearoylethanolamine, N-oleoylethanolamine, and N-palmitoylethanolamine (PEA). A key role of PEA may be to maintain cellular homeostasis when faced with external stressors provoking, for example, inflammation: PEA is produced and hydrolyzed by microglia, it downmodulates mast cell activation, it increases in glutamate-treated neocortical neurons ex vivo and in injured cortex, and PEA levels increase in the spinal cord of mice with chronic relapsing experimental allergic encephalomyelitis. Applied exogenously, PEA has proven efficacious in mast cell-mediated experimental models of acute and neurogenic inflammation. This fatty acid amide possesses also neuroprotective effects, for example, in a model of spinal cord trauma, in a delayed post-glutamate paradigm of excitotoxic death, and against amyloid β-peptide-induced learning and memory impairment in mice. These actions may be mediated by PEA acting through “receptor pleiotropism,” i.e., both direct and indirect interactions of PEA with different receptor targets, e.g., cannabinoid CB2 and peroxisome proliferator-activated receptor-alpha.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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