Vibrating Belt Gets FDA ‘Breakthrough Device’ Designation for Osteoporosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has given “Breakthrough Device” designation to a vibrating belt that lowers the risk of bone fractures caused by osteoporosis. When worn around the waist, the OsteoBoost Vibration Belt delivers gentle stimulation to the hips and spine, simulating the effects of exercise and strengthening bones.

Osteoporosis is caused by the loss of bone mineral density (BMD) and is one of the most common health conditions associated with old age. More than 10 million Americans suffer from osteoporosis and 43 million have its precursor, osteopenia.

About 1 in 2 women and 1 in 4 men over the age of 50 will suffer an osteoporosis-related fracture, usually in their hip or spine. Breaking a bone is especially traumatic for the elderly and can lead to a cascade of health problems, including chronic pain, disability and early death.

Osteoporosis is currently treated with changes in diet, exercise and bisphosphonate drugs such as Fosamax, which slow the loss of BMD. However, long term use of bisphosphonates can lead to side effects such as bone, muscle or joint pain, as well as nausea and heartburn.

“For years, I have wanted a better option for my patients with low bone density that doesn’t have the potential side effects and the inconvenience of current drug treatments. With OsteoBoost we’ve created a safe, drug-free alternative that is easy and convenient. Now my patients with osteopenia have a new way to improve their bone health and reduce their risk of fracture,” says Dr. Shane Mangrum, co-founder of San Francisco-based Bone Health Technologies, which makes the OsteoBoost belt.

OsteoBoost uses whole body vibration (WBV) technology originally developed for NASA to improve the bone health of astronauts in a weightless environment. Here on earth, WBV has been found to improve bone mineral density, but it requires users to stand on a stationary vibrating platform, which isn’t always practical.

Because OsteoBoost is wearable, users can go for a walk or perform simple household chores while getting treatment. It’s recommended the device be used in 30-minute sessions, 3 to 5 times a week.

In a small clinical trial, OsteoBoost reduced bone loss in postmenopausal women by an average of 14%, a reduction similar to bisphosphonates. The National Institutes of Health is funding a larger, $2 million study of OsteoBoost that is currently enrolling postmenopausal patients. It is scheduled to be completed in early 2022.

If that study is successful, the FDA’s Breakthrough Device designation will speed up the agency’s review of OsteoBoost and help bring it to market sooner. The belt is not currently available for purchase and will require a a prescription when it is.

A 2011 Canadian study found that WBV did not improve bone mineral density in postmenopausal women who used a vibrating platform daily for a year while also taking vitamin D and calcium supplements.

"Although commercially available WBV devices are marketed to and used by patients, the beneficial effects of WBV on fracture risk and BMD have not been established, and recent randomized, controlled trials in postmenopausal women have shown conflicting results," said lead researcher Angela Cheung, MD, at University Health Network in Toronto. "Women would be farther ahead in making sure that they are exercising regularly and eating nutritious foods."

12 Holiday Gifts on Life With Chronic Pain

By Pat Anson, PNN Editor

If you live with chronic pain or illness and want to have a friend or family member get a better understanding of what you're going through -- here are 12 books and videos that would make great gifts over the holidays. Or you can always “gift” one to yourself.

Click on the cover to see price and ordering information. PNN receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon. As an Amazon Associate, we earn from qualifying purchases. 

Finding a New Normal: Living Your Best Life with Chronic Illness by Suzan Jackson

For nearly 20 years, Suzan Jackson has lived with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) — a condition she shares with two of her sons. In this book, Jackson shares what she and her family have learned about living well with chronic illness and finding a “new normal” through strong relationships, healthy emotions and finding joy in everyday life. The emphasis is on living life, not just enduring it.

War on Us by Colleen Cowles

Lawyer Colleen Cowles looks at how the war on drugs and myths about addiction have created a dysfunctional drug policy that prosecutes doctors for treating pain and stigmatizes patients for seeking relief. The U.S. has spent over a trillion dollars fighting the war and has little to show for it except some of the highest rates of addiction, overdose and incarceration anywhere in the developed world.

Ketamine Infusions: A Patient’s Guide by Berkley Jones

Berkley Jones looks at the increasing use of ketamine, a non-opioid analgesic, in treating chronic pain, depression, post-traumatic stress disorder and anxiety. This book is a useful guide if you are considering ketamine infusions and want to know how to select a provider, what to expect during infusions and possible side effects. Although primarily used to treat depression, some pain patients say ketamine is effective in treating neuropathy and CRPS.

Bitten: The Secret History of Lyme Disease and Biological Weapons by Kris Newby

Author Kris Newby began looking into the origins of Lyme disease after she was bitten by a tick and became seriously ill. Her research led her to a secret U.S. government program during the Cold War that used insects as biological weapons to spread disease. Newby believes the Lyme outbreak that began 50 years ago and has infected millions of Americans may have been the result of a military experiment gone wrong.

Vagina Problems: Endometriosis, Painful Sex and Other Taboo Topics by Lara Parker

A memoir by Lara Parker that explores — with unflinching honesty — her battle with endometriosis, a chronic vaginal condition that makes daily life difficult and sex painful. As a teenager, doctors initially dismissed Parker’s pain as “bad period cramps” and suggested her pain was psychological. She nearly checked herself into a mental institution before finally getting a proper diagnosis.

A Quick Guide to CBD by Dr. Julie Moltke

CBD won’t cure you of chronic pain, but Dr. Julie Moltke says cannabidiol can reduce pain, inflammation, anxiety and insomnia — and help make life more livable. This handbook is intended for beginners who want to learn how and when to take CBD, and are puzzled by all the hype surrounding vapes, oils, gummies and edibles on the market.

Pain Warriors by Tina Petrova

A documentary produced by patient advocate Tina Petrova that examines the poor treatment and medical neglect faced by millions of pain sufferers in North America. The film is dedicated to Sherri Little, a chronic pain patient who committed suicide after one last attempt to get effective treatment. Available on DVD or for streaming on Amazon Prime.

Together: The Healing Power of Human Connection by Dr. Vivek Murthy

This timely book by former U.S. Surgeon General Dr. Vivek Murthy looks at the importance of human connections and how loneliness affects our health and society at large. To combat loneliness, Murthy recommends spending at least 15 minutes each day connecting with people we care about and to give them our undivided attention.

Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban

Wonder why that generic drug you take doesn’t seem to work? About 90% of pharmaceutical drugs are generic and most are manufactured overseas. While generics are promoted as cheaper alternatives to brand name drugs, journalist Katherine Eban found the generic drug industry rampant with greed, fraud and falsified manufacturing data — resulting in many patients consuming drugs that are ineffective or have dangerous side effects.

In Pain: A Bioethicist’s Personal Struggle with Opioids by Travis Rieder, PhD

Travis Rieder is a professor of bioethics at Johns Hopkins University who severely injured his foot in a motorcycle accident and became dependent on opioids while recovering from surgery. In this book, he shares his frustration with the healthcare system and how it often abandons patients to pain, addiction or both. Rieder serves on a CDC advisory panel that is helping the agency prepare an update of its controversial 2016 opioid guideline.

The Chronic Pain Management Sourcebook by David Drum

A comprehensive guide about chronic pain by medical journalist David Drum, who summarizes the many causes, types and treatments of pain. Drum also has tips on managing stress, anxiety, lack of sleep and depression. The book is easy to understand and would be a useful resource for family members, friends and caretakers who want to understand and help someone living with chronic pain.

A Little Book of Self Care: Trigger Points by Amanda Oswald

This well-illustrated book provides 40 simple, step-by-step exercises you can use to manage back pain, migraine and other painful conditions. Author Amanda Oswald explains how “trigger points” — small knots of muscles and connective tissue — can be relieved through self-massage and the “power of touch” without visiting a chiropractor or physical therapist.

These and other books and videos about living with chronic pain and illness can be found in PNN’s Suggested Reading section.

What Does Intractable Pain Really Mean?

By Forest Tennant, PNN Columnist

Many people have chronic pain. If you are over age 60, you probably have some bothersome pain from arthritis, bunions, carpal tunnel, TMJ or a neuropathy. These common conditions cause intermittent pain which may be quite bothersome.

There are some unfortunate persons, however, who have terrible, grueling pain that just won’t go away. It’s there 24/7. It’s the kind that keeps you awake and makes you feel so sick you can’t read, think or socialize, and it will force you to take cover on the couch or in bed.

The pain can be primarily located anywhere on the body such as the hip, neck or back. But when it flares you feel it “all over” and it is intense.

This constant pain means you have a primary or underlying disease or injury that has emitted and sent so much electricity to the central nervous system (CNS) that inflammation forms inside the brain or spinal cord. The brain chemicals and neurotransmitter-receptor systems (NTRS) that normally control and shut down pain become damaged and impaired. The chemicals your own body makes for pain control, as well as pain medications, ​stop working correctly because of the damage to these chemical-tissue receiving sites.

Constant pain means you ​need a program or protocol to treat your basic injury or disease. One that reduces electric impulses and helps rebuild the damage to the NTRS in your spinal cord and brain. Symptomatic pain relievers are usually a must, but they don’t treat or reverse your basic problem.

Intractable Pain Syndrome

Due to new research, we now call the constant pain condition the Intractable Pain Syndrome (IPS). It’s called a “syndrome” because of the many manifestations of the condition.

IPS is a complication of a disease or injury. To obtain some relief and recovery, every person with IPS must know the name of the disease or injury that started the pain, and the anatomic location on the body that first sustained pain. Our studies have found that many persons with IPS don’t have a diagnosis for the cause of their pain and may have even forgotten the site on their body where the pain originated.

Common causes of IPS are:

• Adhesive Arachnoiditis

• Reflex Sympathetic Dystrophy (RSD) or Complex Regional Pain Syndrome (CRPS)

• Advanced Osteoarthritis

• Genetic Connective Tissue/Collagen Disorder (Ehlers-Danlos Syndrome)

• Traumatic Brain Injury (stroke, trauma)

• Autoimmune Disease

There are other rare causes of IPS, including porphyria, sickle cell disease, interstitial cystitis, Lyme disease and rare genetic disorders.

Vague complaints or diagnoses about back pain, headaches, sprains, strains or “pain all over” are not specific enough to get you much relief or recovery and can’t be considered a legitimate cause of IPS. That’s why it is important to know the specific cause of your pain. What was the specific diagnosis that warranted an epidural injection, surgery or an opioid prescription?

Regardless of what caused your IPS or how long you’ve had it, your original pain site is problematic and needs to be identified. The site is generating inflammation and electricity, and could be scarred in a way that blocks the normal flow of electricity through the body.

The major goal of the IPS Research and Education Project is to bring awareness that simple chronic pain and IPS are quite different entities. A second goal is to bring recognition, prevention and treatment of IPS into mainstream medical practice at the community level. IPS must be known, recognized and treated in the ambulatory medical system like any other long-term care problem such as rheumatoid arthritis, emphysema, diabetes, asthma, or schizophrenia.

It must also be done along with physical, psychologic and pharmaceutical measures that are acceptable to all concerned parties and that don’t require high, risky dosages of abusable drugs.

Forest Tennant is retired from clinical practice but continues his groundbreaking research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation has given financial support to Pain News Network and is currently sponsoring PNN’s Patient Resources section.  

FDA Designates First Virtual Reality Device for Chronic Pain

By Pat Anson, PNN Editor

AppliedVR, a Los Angeles-based virtual reality company, has announced that its EaseVRx headset has received Breakthrough Device Designation from the Food and Drug Administration for treating fibromyalgia and chronic intractable low back pain.

EaseVRx is the first virtual reality (VR) device to get a Breakthrough Designation from the FDA for treating a chronic pain condition. The designation speeds up the development and review of new medical devices that treat life-threatening or irreversibly debilitating diseases or conditions. It could also speed up insurance coverage of VR therapy for chronic pain.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” Matthew Stoudt, CEO and co-founder of AppliedVR, said in a statement.

“Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.” 

AppliedVR funded a recent clinical trial that showed VR therapy can be self-administered at home to treat chronic pain. Patients living with fibromyalgia or chronic lower back pain were given VR headsets and instructed to watch at least one virtual reality program daily for 21 days.

The programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is to help patients learn how to manage their pain and other symptoms by distracting them and making their pain seem less important

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy. Their pain intensity was reduced an average of 30 percent. Physical activity, mood, sleep and stress levels also improved.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Beth Darnall, PhD, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

PNN columnist Madora Pennington, who lives with chronic pain from Ehlers-Danlos Syndrome, recently reviewed one of AppliedVR’s headsets. She said watching VR programs helped calm and relax her.

“The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to,” Madora wrote. “After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.”

AppliedVR’s technology is being used in hundreds of hospitals, but is not expected to be available for home use until next year. The company is working with Geisinger Health and Cleveland Clinic on two studies to see if VR therapy can be used as an opioid-sparing tool for acute and chronic pain.

VR for Phantom Limb Pain

Virtual reality technology received another boost this week when the Department of Defense awarded Chicago-based Coapt a $2.3 million grant to develop virtual reality therapies for phantom limb pain. Wounded veterans and amputees who have lost arms or legs often suffer from nerve pain and other sensations from their missing limbs.

"Phantom limb pain is a serious and persistent challenge for many upper and lower-limb amputees, and new, technology-based therapies have incredible promise," Blair Lock, co-founder and CEO of Coapt, said in a statement. "Preliminary work has shown that VR-based, actuated therapy can manage pain more effectively and have lasting effects. This grant will allow us to further study this therapy and bring to market a solution for those suffering from phantom limb pain in a way that also happens to be engaging."

Coapt has previously developed a VR-based therapy to help upper-limb amputees improve control of their prostheses. The technology also shows promise as a treatment for phantom limb pain. Coapt will use the grant money to further study the effectiveness of VR therapy and create a commercially viable product for both civilians and veterans with upper and lower-limb amputations.

Quell Customers to Receive $3.9 Million in Refunds

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is sending refunds of nearly $3.9 million to consumers who bought Quell, a wearable nerve stimulation device touted as a drug-free treatment for chronic pain. The refunds are part of a settlement the FTC reached in March with NeuroMetrix – the maker of Quell – over deceptive advertising.

An FTC complaint alleged that NeuroMetrix and CEO Shai Gozani advertised Quell as an effective treatment for fibromyalgia, osteoarthritis, sciatica, shingles and other chronic pain conditions without reliable scientific evidence to back it up.  

Two clinical studies cited in Quell advertisements had “substantial flaws,” according to the FTC, while a third study was based on a marketing survey conducted by the company to “generate potential advertising claims” about the device. The FTC also objected to claims that Quell was “clinically proven” and “FDA cleared” for chronic pain relief.

“Defendants engaged in their unlawful acts and practices repeatedly over a period of more than four years, continued their unlawful acts or practices despite knowledge of complaints that advertising claims for Quell were not substantiated and went beyond claims the FDA allowed for similar devices, and continued such deceptive advertising unabated until FTC staff notified them it would recommend law enforcement action,” the FTC complaint said.

Neurometrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn.

The FTC is using the settlement funds to send 2,144 refund checks and 67,998 refunds via PayPal to Quell purchasers. The average refund amount is $55.10 per customer. Consumers who do not receive a refund, but believe they should, should contact the refund administrator, Rust Consulting, at 1-866-403-6545.

The Quell device sells for $299, while an older version is available for $199. Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance.

NeuroMetrix recently announced that Quell will be used in a clinical trial on the use of transcutaneous electrical nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy  The study is being conducted at the University of Rochester School of Medicine and Dentistry, with funding from the National Institutes of Health. Quell is also being evaluated in a small study as a treatment for fibromyalgia.

Good Attitude Improves Effectiveness of Yoga and Physical Therapy

By Pat Anson, PNN Editor

Yoga is a four-letter word for a lot of chronic pain patients, who are often urged to try yoga or physical therapy to ease their pain. Many pain sufferers believe exercise will only make their pain worse.

But a new study by researchers at Boston Medical University found that people with chronic lower back pain are more likely to benefit from yoga and physical therapy if they have a positive attitude about exercise.

The study involved 299 mostly low-income patients with chronic lower back pain who took weekly yoga classes or had physical therapy for 12 weeks. They were compared to a control group who had “self-care” – which consisted of reading a handbook on self-management strategies for back pain, such as stretching and strengthening exercises.

Nearly half (42%) of those who had yoga or physical therapy responded to the treatment, while only 23% of those in the self-care group had improvement in their pain and physical function.

Interestingly, participants who continued taking pain medication during the study were more likely to benefit from yoga (42%) than those who had physical therapy (34%) or self-care (11%).

"Adults living with chronic low back pain could benefit from a multi-disciplinary approach to treatment including yoga or physical therapy, especially when they are already using pain medication,' said lead author Eric Roseen, DC, a chiropractic physician at Boston Medical Center.

Another important finding from the study, which was published in the journal Pain Medicine, is the effect that “fear avoidance” can have on patient outcomes.

Among the participants who had less fear of exercise, 53 percent responded to yoga, 42 percent responded to physical therapy and 13 percent responded to self-care. In contrast, participants who had a high fear of exercise usually had a poor response, regardless of what therapy group they were in.  

Other factors that appeared to improve patient response were a high school education, higher income, employment and being a non-smoker.

"Focusing on a diverse population with an average income well below the U.S. median, this research adds important data for an understudied and often underserved population," said Roseen. "Our findings of predictors are consistent with existing research, also showing that lower socioeconomic status, multiple comorbidities, depression, and smoking are all associated with poor response to treatment."

It doesn’t take a lot of time to benefit from exercise. A 2017 study found that just 45 minutes of moderate physical activity a week improved pain and function in patients with osteoarthritis.

A few weeks of yoga significantly improved the health and mental well-being of people suffering from arthritis, according to a 2015 study at Johns Hopkins University.

Virtual Reality Therapy Can Reduce Chronic Pain at Home

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) can reduce chronic pain, improve mood and help people sleep, according to a small study of 74 patients living with fibromyalgia or chronic lower back pain.

The research, published online in JMIR-FR, is one of the first to look at the effectiveness of VR therapy when self-administered at home by chronic pain patients. It was funded by AppliedVR , a Los Angeles based company that is developing therapeutic VR content to help treat pain, depression, anxiety and other conditions.

“People with chronic pain often have limited access to comprehensive pain care that includes skills-based behavioral medicine. We tested whether VR that was self-administered at home would be an effective therapy for chronic pain,” said Beth Darnall, PhD, a pain psychologist who is AppliedVR’s chief scientific advisor.

“We found high engagement and satisfaction, combined with clinically significant reductions in pain and low levels of adverse effects, support the feasibility and acceptability for at-home, skills-based VR for chronic pain.”

Participants in the study were given VR headsets and instructed to have at least one session daily for 21 days. Half of the patients listened to audio-only programming, while the other half watched “virtual” programs in which they could swim with dolphins, play games or immerse themselves in beautiful scenery.

The programs are designed to help patients learn how to manage their pain and other symptoms by using cognitive behavioral therapy (CBT) to distract them and make their pain seem less important.

A sample of what they saw can be seen in this video:  

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy, which worked significantly better than the audio-only format in reducing five key pain indicators:

• Pain intensity reduced an average of 30%

• Physical activity improved 37%

• Mood improved 50%

• Sleep improved 40%

• Stress reduced 49%

Previous VR studies have had similar findings, but have largely focused on patients in hospitals and clinical settings. 

“This study is a fundamental step for advancing a clinically proven, noninvasive and safe digital therapeutic like VR for chronic pain, and demonstrates our platform is both viable and efficacious,” said Josh Sackman, co-founder and president of AppliedVR.

“Living with and managing chronic pain daily can be a debilitating and costly challenge, and many patients suffering from it can feel hopeless and desperate for any relief. So, as we engage in and accelerate more in-depth clinical research, we want them to know that we’re committed to making VR a reimbursable standard of care for pain.”

AppliedVR products are being used in hundreds of hospitals, but are currently only available to healthcare providers. The company recently partnered with University of California at San Francisco to study how VR therapy can improve patient care for underserved populations.

AppliedVR is also conducting two clinical trials to see if VR therapy can reduce the use of opioid medication for acute and chronic pain. The National Institute on Drug Abuse recently awarded nearly $3 million in grants to fund the trials.

The company is currently recruiting patients with chronic lower back pain for an 8-week trial of VR therapy. Headsets and other material will be mailed at no cost to participants at their homes. No in-person visits are required.  

Long-Term Use of Muscle Relaxants Has Tripled

By Pat Anson, PNN Editor

Long-term use of muscle relaxants has nearly tripled in the U.S. since 2005, according to a new study by researchers at the University of Pennsylvania, who say the drugs are often prescribed inappropriately for chronic pain and to older adults.

Skeletal muscle relaxants (SMRs) like carisoprodol (Soma) and metaxalone (Skelaxin) were approved years ago for short-term treatment of muscle spasms and back pain. Researchers believe many doctors are now prescribing the drugs as an alternative to opioids for long-term pain management.

"There are few studies on the short-term efficacy and safety of skeletal muscle relaxants, and almost no data on their long-term effects, so it is very concerning that patients, and particularly older adults, are using these drugs for an extended period of time," said Charles Leonard, PharmD, an assistant professor of Epidemiology at Perelman School of Medicine. "Providers seem to be reaching for them despite incomplete information on their potential benefits and risks."

Medical guidelines generally recommend limiting the use of muscle relaxants to three weeks because they have not been shown to work for muscle spasms beyond that duration. The drugs can also have side effects such as falls, fractures, vehicle crashes, abuse and dependence. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

To measure national trends in muscle relaxant prescribing, researchers analyzed the number of office visits that resulted in muscle relaxant prescriptions from 2015 to 2016. They found the number of new prescriptions remained stable at about 6 million per year. But office visits for renewals of muscle relaxant prescriptions tripled -- from 8.5 million in 2005 to 24.7 million in 2016.

Over two-thirds (67%) of the patients getting renewals for muscle relaxants in 2016 were also taking opioid medication, despite an FDA warning that co-prescribing the drugs could lead to respiratory depression and overdose. Older adults accounted for about one in four (22%) office visits for muscle relaxants.

"For older adults, I think the message should be to avoid using muscle relaxants, especially when we consider the side effects and increased risk of falls and fractures, and to find alternatives for pain management," said first author Samantha Soprano, MPH, a research coordinator and student in Penn's Master of Behavioral and Decision Sciences program.

In addition to potential side effects, researchers say muscle relaxants may not be any more effective in managing pain than medications like Tylenol or Advil.

"Muscle relaxants' place in therapy is really limited. Based on most guidelines, they're normally reserved as second- or third-line therapies," Leonard said. "Our findings suggest that prescribers may be reaching for these drugs sooner than that."

The findings are published in JAMA Network Open.

New Drug Relieves Back Pain, But Safety Issues Remain

By Pat Anson, PNN Editor

An experimental non-opioid pain reliever gives long-term relief for chronic low back pain, but questions remain about joint damage and other side effects from the drug, according to a large new study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein in the blood that heightens pain sensitivity. Tanezumab binds to NGF and inhibits pain signals from reaching the brain.

In a Phase III study of over 1,800 patients with difficult-to-treat low back pain, participants given an injection of tanezumab once every two months had significantly more pain relief than those given tramadol or a placebo. The study was funded by Pfizer and Eli Lilly, which have spent nearly a decade jointly developing tanezumab as an alternative to opioid medication.

"This demonstration of efficacy is a major breakthrough in the global search to develop non-opioid treatments for chronic pain," said lead author John Markman, MD, director of the Translational Pain Research Program at the University of Rochester Medical Center. "There were also improvements in function linked to the reduction in pain severity."

But this “major breakthrough” is tainted by the fact that about 10% of patients given 10mg of tanezumab had joint pain or other side effects. Seven of them needed total joint replacement surgery. Patients who received 5mg injections of tanezumab had fewer side effects, but less relief from back pain.

NGF inhibitors have previously been linked to a rapidly progressive form of osteoarthritis. But researchers say other methods of treating back pain, such as opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and surgery, have their own safety risks.

"In the future, clinicians may have to weigh the different risks of lumbar fusion surgery, chronic opioid use, or NSAIDs against the unique risks of a rare but rapidly progressive form of joint problem associated with blocking nerve growth factor," said Markman. "I expect that that the tradeoffs between benefit and risk will be different for osteoarthritis than for chronic low back pain."

Tanezumab is currently under review by the Food and Drug Administration as a treatment for moderate-to-severe osteoarthritis (OA), with a decision expected late this year. In a 2019 study of osteoarthritis patients taking a 5mg dose of tanezumab, there was significant improvement in their pain and physical function. But about 6% experienced rapidly progressive osteoarthritis.

Pfizer and Eli Lilly are not currently pursuing tanezumab as a treatment for chronic low back pain (CLBP).  

“Pfizer and Lilly made the decision to prioritize OA based on an assessment of the totality of SC tanezumab data and an initial discussion with the FDA,” a Pfizer spokesman said in an email to PNN. “At this time, regulatory submissions are not planned for tanezumab in patients with moderate-to-severe CLBP. Additional data analyses, and potentially further clinical study, may be required to more fully characterize tanezumab in CLBP patients.”

The new study was published in the journal Pain. Some of its findings had previously been released by Pfizer and Lilly.

Patients Recover Sooner from Minimally Invasive Back Surgeries

By Pat Anson, PNN Editor

A new study comparing short-term outcomes of minimally invasive lumbar decompression surgeries to minimally invasive spinal fusions found no significant difference in the amount of time patients needed to return to work. But decompression patients were able to drive and stop taking opioid pain medication sooner than the fusion patients.

Researchers at Hospital for Special Surgery (HSS) in New York City found that it took 117 decompression patients a median of three days to discontinue opioid medication, while it took a median of seven days for 51 spinal fusion patients.

It took 88 decompression patients a median of 14 days to resume driving, while it took 18 days for 45 fusion patients.

The findings are noteworthy, according to Sheeraz Qureshi, MD, an HHS spine surgeon, because a standard open spinal fusion generally entails a much longer recovery and slower return to activities than a standard lumbar decompression.

“Our study is the first of its kind to look at return to activities and discontinuation of narcotic pain medication after single-level lumbar decompression or single-level lumbar spine fusion performed with a minimally invasive technique,” said Qureshi, who was senior investigator for the study.

“All the patients in both groups were able to resume driving and return to work within three weeks of surgery. When you compare this time frame to that of standard open spinal fusion surgery, it’s really striking. Patients having a standard spinal fusion could take six months or longer for a full recovery.”

Degenerative conditions of the lumbar spine, such as a herniated disc or spinal stenosis, are common causes of chronic back pain. Patients may consider surgery when conservative treatments such as medication and physical therapy fail to provide relief.

Lumbar decompression surgery involves the removal of a small section of bone or part of a herniated or bulging disc that is pressing on a nerve. Spinal fusion is more extensive surgery, and is performed to stabilize and strengthen the spine. Surgeons join two or more vertebrae together, sometimes using screws and connecting rods.

In recent years, minimally invasive (MI) spine surgery has gained in acceptance and popularity. The technique uses smaller incisions than standard surgery and aims to minimize damage to nearby muscles and other tissues.

Although MI decompressions and MI fusions use the same initial approach to reach the spine with the same size incisions, the fusions are still more extensive surgeries, so pain medication may be needed for a longer period of time, according to Dr. Qureshi.

This study findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

Most Patients Say Cannabis Effective for Musculoskeletal Pain

By Pat Anson, PNN Editor

The vast majority of people with musculoskeletal pain who have tried medical cannabis say it is an effective pain reliever and over half believe it works better than other pain medications, according to a new study released by the American Academy of Orthopaedic Surgeons.  

Researchers surveyed 629 patients being treated at orthopaedic clinics to see how widely cannabis is being used for chronic muscle and joint pain that can be caused by arthritis, fibromyalgia, osteoporosis and many other conditions.

“Over time, we’ve certainly seen an increase in the use of cannabis to manage musculoskeletal (MSK) pain,” said lead author Timothy Leroux, MD, an orthopaedic surgeon and assistant professor at the University of Toronto.

“There is definite interest to see if cannabis can be used to manage chronic MSK pain, as opposed to other conventional treatments such as anti-inflammatories and opioids. With this study, we wanted to get a lay of the land as to who is using it, what proportion are using and what they perceive the efficacy to be.”

One in five of the patients surveyed said they are currently using or have tried cannabis to manage their MSK pain. Of those, 90% said cannabis was effective, 57% believe it works better than other pain medications, and 40% said it decreased their use of other drugs.

Patients who used cannabis for MSK pain were more likely to have multiple conditions, including depression, back pain, chronic pelvic pain and chronic neck pain. They were also more likely to use muscle relaxants and opioids for pain relief.

The most common form of cannabis used was cannabidiol (39%) and the most common route of ingestion was CBD oil (60%). Over a third of patients said they spent at least $200 per month on cannabis products.

Among the cannabis users, only 26% received a recommendation from a physician. Most said they tried cannabis at the urging of a friend or family member.

“Most doctors, especially orthopaedic surgeons, don’t have prescribing power for cannabis, so there is minimal physician oversight when it comes to cannabis use to manage chronic MSK pain,” said Leroux. “To complicate things, it’s a little bit of a Wild West in the cannabis industry in terms of what you get in a product, namely actual vs. labelled composition, and consistency.

“Another challenge is that we don’t fully know what products, formulations, dosages, and routes of administration are best to manage chronic MSK pain. Given the high rate of use observed in this study and little physician oversight, there’s an impetus for us as a medical community to try to understand what role, if any, cannabis may serve in the management of chronic MSK pain.”

Even among non-users, there was a fair amount of interest in cannabis. Sixty-five percent reported an interest in trying cannabis for MSK pain. Common barriers to using cannabis were stigma and lack of knowledge about its efficacy, doses and routes of administration.

“We tend to associate cannabis with a younger age due to recreational use, but in our study, age was not a significant factor influencing use for the management of chronic MSK pain,” said Leroux. “Patients reported use well into their 80’s, many whom we assumed would want to use more conventional products.

“We’d like to repeat this study in the next few years to see how use and demographics change as people become more comfortable with the idea of cannabis as the norm as well as what role state legalization plays in patients’ attitudes towards its use.”

Arachnoiditis Nearly Destroyed My Life

By Robert Perry, Guest Columnist

I was a pipe welder when I first hurt my back in 1992. The doctor ordered a myelogram imaging test on my back with a chemical dye. It was one of the most painful tests I ever had. After the test the doctor told me I had to learn to live with my pain. At that time, I was only 27 years old. The doctor told me I might be able to work for another 15 years.

He was right about that. In 2008, I was a project manager at ATT and started losing the ability to use my legs. One day I couldn’t get out of bed for about 3 hours because I was having so much pain in my legs and lower back. I was screaming from the pain and the muscles spasms were so bad it made me cry.

I started falling at work and hurting so bad it was unreal, so they did an MRI on me and found I had Arachnoiditis. Since then my life has been a hard road. It’s unreal how many doctors don’t know anything about this disease. One doctor did 5 epidural steroid injections on me and made it worse.

Another doctor put a spinal cord stimulator temporarily in my back to see if it would help, but he accidentally punctured my spine and left an air bubble. I went home and late that night got a terrible headache that felt like it was killing me. My ex-wife and kids took me to the emergency room. I was about to die from the bubble in my body.

They finally found the bubble in my body by cat scan. The only way you can get a bubble out is to remain really calm, so they started giving me a strong painkiller in an IV drip.  But the nurse wasn’t paying attention and I overdosed. I knew I was dying and thank God that a person came in to clean my room and I got her to go get help.

ROBERT PERRY

I had her call my family on my cell phone. I was able to tell my family goodbye. Right after that, I lost consciousness. I finally woke up 8 hours later and the doctor was waiting on me to ask me things to see if I had any brain damage. The first thing I asked was for my dad, but I couldn’t remember that my dad was dead until they told me.

I have been through a lot because of Arachnoiditis. I lost my family and now I am married to a wonderful lady who knows I am a very sick person.  This disease is the one of the most painful. I have to take two shots a month and I am on a lot of meds. I have a good doctor now who put me on a fentanyl pain patch and my life has been a lot better.

I am a preacher and have a lot of faith. One night at church I was in so much pain the congregation was about to take me to the hospital. And I told God that night either heal me or take me. They prayed over me and I walked out of the church without any pain or my cane.

That’s was 5 years ago and I am still doing a lot better and able to live now. The doctors can’t help, but God can. I am very thankful for that night in prayer.

Arachnoiditis nearly destroyed my life. I hope they one day find a cure for this terrible disease. Before God touched me that night, I was about ready to take my life because of the pain.

Robert Perry lives in Kentucky.

PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Study Finds Opioids and Imaging Tests Given Too Often for Low Back Pain

By Pat Anson, PNN Editor

Many Medicare patients with low back pain receive care that is contrary to clinical guidelines – including opioid medication and advanced imaging tests, according to a large new study.

Researchers looked at Medicare claims for over 162,000 older adults with new low back pain (LBP) from 2011 to 2014. Over half (54%) made only one healthcare visit for LBP, which is consistent with evidence that many new cases of LBP "improve over time regardless of treatment."

It's what happened to the other patients that researchers found concerning.

Opioids were prescribed to about one-fourth of patients overall, and to about a third of those who made two or more visits to have their low back pain treated. Most clinical guidelines for LBP recommend that physical therapy and non-opioid pain relievers such as nonsteroidal anti-inflammatory drugs (NSAIDs) be tried before opioids.

Advanced imaging tests such as cat scans and magnetic resonance imaging (MRI) were ordered for about 15 percent of patients, which is contrary to advice from the American Academy of Family Physicians that most patients don't need advanced imaging for initial evaluation of low back pain.

Physical therapy (PT) was prescribed to only 11 percent of the Medicare patients. Most who were treated with opioids did not receive a prescription NSAID or physical therapy. Chronic opioid use developed in about one percent of patients overall, and nearly two percent of those with two or more visits.

"This study raises concerns about excessive use of low-value and potentially harmful treatments for the common problem of LBP in older adults," said Dan Pham, MD, of Harvard University, who published his findings in the journal Medical Care.

“Although prior research has suggested that PT may forestall the use of opioids in LBP, it is surprising that a high percentage of patients do not receive PT at all and many patients who eventually receive opioids did not first try PT. Similarly, it is surprising that when guidelines suggest that opioids should be a last resort for LBP, many patients on opioids have not yet tried prescription NSAIDs.”

It’s worth noting that Pham’s study only analyzed Medicare data compiled before the release of the 2016 CDC opioid guideline, which led to a widespread campaign to reduce opioid prescribing. Many physicians now refuse to prescribe opioids or only do it at low doses.  

Lower back pain is the world’s leading cause of disability. Over 80 percent of us suffer acute low back pain at least once in our lives.  

A guideline released by the American College of Physicians in 2017 strongly recommend that physicians treat acute low back pain with exercise and other non-pharmacological therapies. If medication is used, the guideline recommends NSAIDs or muscle relaxers. Opioids are only recommended for patients with chronic back pain who have failed at other treatments.

Some treatment guidelines also take a dim view of imaging for people with acute back pain. Early imaging for lower back pain is not recommended by the Choosing Wisely campaign, an initiative of the ABIM Foundation.

“Most people with lower-back pain feel better in about a month whether they get an imaging test or not. In fact, those tests can lead to additional procedures that complicate recovery,” Choosing Wisely states on its website.

The University of Michigan Center for Value-Based Insurance Design estimates there were 1.6 million unnecessary images for low-back pain in 2014, resulting $500 million in wasted spending. The Center recommends that imaging not be done in the first 6 weeks of low back pain.

A 2015 study found that physical therapy for low back pain significantly lowers healthcare costs by reducing the use of expensive treatments such as spinal surgery, injections and imaging.

Mayo Clinic Research Shows Stem Cells May Treat Paralysis

By A. Rahman Ford, PNN Columnist

In a case report recently published in Mayo Clinic Proceedings, a 53-year-old California man paralyzed from the neck down in a surfing accident experienced dramatic improvement after an injection of his own stem cells.  

Chris Barr can walk again and has shown other improvements in his motor and sensory functions. His case is significant, because currently there is no FDA-approved therapy that can reverse the devastating life-changing effects of paralysis from spinal cord injuries.

Barr’s inspiring story can be seen in this video produced by the Mayo Clinic:

Barr was one of 10 paralyzed adults enrolled in a Phase I clinical trial that looked at the safety, side effects and ideal dose of stem cells. Early findings show that patient response varied. Mayo researchers call Barr a “superresponder” because his treatment was so successful.

"In this case report, the first patient was a superresponder, but there are other patients in the trial who are moderate responders and nonresponders," says first author Mohamad Bydon, MD, a Mayo Clinic neurologic surgeon. "One of our objectives in this study and future studies is to better delineate who will be a responder and why patients respond differently to stem cell injections.”

According to the National Spinal Cord Injury Statistical Center, about 288,000 Americans currently suffer from a spinal cord injury (SCI). Over 17,000 Americans suffer SCI’s each year, costing the health care system over $40 billion annually.  The estimated lifetime cost for each patient can range from the hundreds of thousands into the millions of dollars, and their life expectancy rates fall far below those without SCI.

Chronic pain is a serious problem that can result from SCI, affecting about two-thirds of patients, with one out of three reporting their pain as severe. With the inherent limitations of medical interventions such as surgery, medication and physical rehabilitation, new strategies are needed to improve functional outcomes and quality of life.

Although stem cells have  successfully been used to treat inflammatory conditions that affect the spinal cord, such as arachnoiditis, published reports on their safety and effectiveness in treating SCI‘s are scant.

Animal studies have demonstrated effectiveness in treating SCI with embryonic stem cells and human neural stem cells. Mesenchymal stem cells (MSC’s) derived from bone marrow have also been successfully used to treat SCI in rats, as have human umbilical cord-derived stem cells. And adipose stem cells derived from fat have been used to improve functional recovery in dogs with SCI.

Barr’s Impressive Results

After being paralyzed in the surfing accident, Chris Barr’s condition initially improved after a posterior cervical decompression and fusion. However, that improvement plateaued after six months. Barr had complete loss of motor function below the site of his injury, including bowel and bladder sensation.

Barr enrolled in the Mayo study nine months after his injury. His stem cells were collected by taking a small amount of fat from his abdomen. Over eight weeks, the cells were grown in the laboratory to 100 million cells. Those MSC cells were then injected into Barr’s lower back, 11 months after his injury.

The results from the therapy were impressive and long lasting. Eighteen months after stem cell injection, Barr’s total upper extremity motor score increased from 35 to 44. There was also considerable improvement in his total lower extremity motor scores, from 36 to 49. Improvement in sensory scores was likewise remarkable.

Barr reported significant improvement in his quality of life, as well as mental and physical health. He was able to walk further, faster and for a longer period of time. His range of motion for shoulder flexion and shoulder abduction also improved.

“Given the multidimensional complexity of SCI, cell-based therapies have offered substantial promise as a therapeutic strategy because of the multifactorial roles that stem cells can potentially provide,” Bydon wrote.

Bydon and his colleagues caution in generalizing from Barr’s remarkable results, although there is cause for optimism. The Mayo team plans to continue analyzing patient responses, and further results will be published on the other nine trial participants.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

This column is not intended as medical advice and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Power of the Pen

By Michael Emelio, Guest Columnist

It's my hope that this column can serve as a powerful example of the harm that can be caused when people are denied adequate pain management. And in so, I pray that it also serves as a lesson to doctors and is something that our lawmakers, CDC and DEA will take a moment to seriously consider.

To understand the full magnitude of the damage that's been caused, I implore you to read a guest column I wrote last year, in which I described how the opioid medication I take for intractable back pain was rapidly tapered to a lower dose, leaving me bedridden and disabled.

It's high time that the harm being inflicted on me and other innocent victims of the opioid crisis is both acknowledged and stopped!

While I can totally sympathize with a doctor's fear of repercussions from the DEA, there comes a point where it's no longer a valid or acceptable excuse. One of those points is when a doctor, with no medically valid reason, refuses to sufficiently treat a person's pain and it results in harm to that patient.

And when a doctor refuses to prescribe a reasonable opioid dose (especially one that is within the CDC opioid guideline) and it causes a patient's condition to significantly worsen, how are they not responsible for that harm?

Speaking with other patients, I've been hearing a familiar story quite a bit lately. So much in fact, that it appears to be becoming an epidemic. Doctors with no medically valid reason are either failing or refusing to prescribe even within the CDC’s 90 MME guideline, while using the same old "well the DEA threatens to take our licenses away" excuse. 

Not only is it getting old, but it's getting people hurt and worse. And when I say that excuse is killing me, I may just mean literally!

Since the tapering started, I've gained 55 pounds and my blood sugar and cholesterol have soared to alarming rates. So in addition to all the things I can no longer do and my pain and suffering increasing, I'm now at risk of both heart disease and diabetes. Irrefutably, this is a direct result of being bedridden 24 hours a day due to the med cuts.

But it doesn't stop there. Adding insult to injury, these med cuts are also robbing me of the only chance I have to improve my condition.

Surgery Not An Option

It cannot be emphasized enough that I've seen several highly-acclaimed surgeons, who are absolutely unanimous in what options I have. They've all said the same thing: Surgery is not an option for me and due to the nature of my condition I should avoid any invasive procedures as they can make my pain worse. This includes spinal injections, radiofrequency ablation, spinal cord stimulators and pain pumps, to name a few.

They've all said that the only viable options I have left are pain meds and physical therapy. The latter is essential because “mobility is crucial to help reduce the pain and improve function.” And to slow my rate of deterioration, I should do “as much physical therapy as possible." 

So by denying me the ability to complete physical therapy due to his forced med cuts, my doctor is not only robbing me of my only chance for improvement, he is directly causing my condition to worsen at an accelerated rate. Despite explaining all of this to him, my doctor informs me that he still plans on reducing my meds even further!

On what planet does this make any sense whatsoever? When you consider all the aspects of my condition and the damage the previous met cuts have already caused, how can this be helpful in any way, yet be a necessary or even a reasonable course of action?

Especially when I'm only at 60 MME, which is considerably less than the CDC's 90 MME guideline. Furthermore, I've been a patient of his for over a year and a half and have proven to take my medications responsibly the entire time, as well as the previous 18 years I've been in pain management.

“Because of the CDC guideline and the fear instilled by the DEA, my doctor is covering his ass and slowly killing me.”

— Micahel Emelio

Think about this for a minute. I have a medical need for pain meds because of an incurable condition that is causing such severe intractable pain that I'm bedridden to the point that I struggle to care for myself properly. It’s also a condition where surgery and invasive procedures are not an option, all other methods and medications have failed, and the only chance for improvement is through physical therapy. Then add the fact that my health is in a serious state of decline as a direct result of the med cuts, and he still wants to cut them even more?

Unless you're in this boat yourself, you can't fathom the level of stress this causes. I'm literally afraid I may have a heart attack from it.

You have to understand the impact that just one more med cut would have on me. I live alone, have no one to help me, and with the dose I'm currently at, I'm already struggling most days just to microwave a TV dinner, yet alone clean my house or even care for myself properly. If he cuts my meds any further, the effect it will have on my life will be devastating.

As I sat in my car outside his office, the only thing I could think about was that if he reduces my meds any further, not only will my pain be unbearable, but I won't even be able to care for myself anymore. Being alone and poor, I only see two options at that point: street drugs or suicide. 

Make no mistake. That is the hand that is being forced on people when intractable pain is not treated!

Never in a million years could I have imagined being in this position. But sadly, this is my reality. And the truly astonishing part of it all is that he could stop all this damage and immensely change my life for the better tomorrow, simply by prescribing 2 more tablets a day, which would still be within the CDC guideline.

But no! Because of the CDC guideline and the fear instilled by the DEA, my doctor is covering his ass and slowly killing me. It's both staggering and terrifying knowing how much control he has over my life with just the swipe of his pen.

Which brings me to an interesting point. In medical school they teach about a thing they call the "power of the pen." It means to make sure that what they prescribe doesn't cause harm to the patient. I just wish my doctor realized that the power of the pen works both ways!

Michael Emelio lives in Florida. Michael lives with severe degenerative disc disease, scoliosis and fibromyalgia. He has safely used opioid medication since 2001.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.