Unnecessary Back Surgeries Performed Every 8 Minutes at U.S. Hospitals

By Pat Anson

Over 200,000 unnecessary or “low value” back surgeries have been performed on older patients at U.S. hospitals over the last three years, about one procedure every eight minutes, according to a new report.

The analysis by the Lown Institute estimates the potential cost to Medicare at $2 billion for unnecessary spinal fusions, laminectomies and vertebroplasties. The procedures either fuse vertebrae together, remove part of a vertebra (laminectomy), or inject bone-like cement into fractured vertebrae (vertebroplasty) to stabilize them.

Lown maintains that fusions and laminectomies have little or no benefit for low-back pain caused by aging, while patients with spinal fractures caused by osteoporosis receive little benefit from vertebroplasties.

“We trust that our doctors make decisions based on the best available evidence, but that’s not always the case,” said Vikas Saini, MD, president of the Lown Institute, an independent think tank that analyzed Medicare and Medicare Advantage claims from 2019 to 2022.  

“In spinal surgery, as with other fields of medicine, physicians routinely overlook evidence to make exceptions, sometimes at shockingly high rates. This type of waste in Medicare is costly, both in terms of spending, and in risk to patients.”

Up to 30 million Americans receive medical care for spine problems each year. While surgery is appropriate for some, the Lown Institute considers many common surgeries overused and of low value to patients. Potential risks include infection, blood clots, stroke, heart and lung problems, paralysis and even death.

Spinal fusions and laminectomies are considered useful for patients who have low back pain caused by trauma, herniated discs, discitis, spondylosis, myelopathy, radiculopathy and scoliosis. Fusions are also appropriate for patients with spinal stenosis from neural claudication and spondylolisthesis; and laminectomies are appropriate for patients with stenosis who have neural claudication.

Wide Variation in Overuse Rates

Nationwide, about 14% of spinal fusions/laminectomies met the criteria for overuse, while 11% of surgery patients with osteoporosis received an unnecessary vertebroplasty.  

The Lown Institute found a wide variation in overuse rates at some of the nation’s largest and most prestigious hospitals. UC San Diego, for example, had a 1.2% overuse rate for fusions and laminectomies; while the Hospital of the University of Pennsylvania had a 32.6% overuse rate.

The largest overuse rate was at Mt. Nittany Medical Center in Pennsylvania, where nearly two-thirds (62.8%) of the fusions and laminectomies were considered inappropriate or of low value.

The Lown report found that over 3,400 doctors performed a high number of low-value back surgeries. Those physicians received a total of $64 million from device and drug companies for consulting, speaking fees, meals and travel, according to Open Payments. Three companies — Nuvasive, Medtronic and Stryker — paid over $22 million to doctors who performed the unnecessary surgeries.

Previous reports by the Lown Institute have also questioned the value of procedures such as knee arthroscopies, a type of “keyhole” surgery in which a small incision is made in the knee to repair ligaments. Research has found that arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long-term.

The American Hospital Association takes a dim view of Lown studies, calling the data cherry-picked and misleading.

Muscle Relaxants Ineffective for Low Back Pain and Fibromyalgia

By Pat Anson

Muscle relaxants are increasingly prescribed “off label” as an alternative to opioid medication, but according to a new analysis they are no more effective than a placebo in treating fibromyalgia and low back pain. They may be beneficial, however, for patients suffering from muscle cramps, neck pain and trigeminal neuralgia.

Researchers reviewed 44 studies involving nearly 2,500 patients who were prescribed a muscle relaxant for various pain conditions. Nine skeletal muscle relaxants (SMRs) were assessed, drugs that were initially developed and then approved by the FDA as anti-spasticity and anti-spasmodic medications:

• Carisoprodol (Soma)

• Baclofen

• Tizanidine

• Cyclobenzaprine

• Eperisone

• Quinine

• Orphenadrine

• Chlormezanone

• Methocarbamol

Despite a lack of evidence on their effectiveness beyond 3 weeks, prescribing of SMRs doubled between 2005 and 2016, with office visits for refills of SMR prescriptions tripling over the same period, indicating they were increasingly being used long-term and off-label. According to a 2021 study, over a third of patients prescribed SMRs did not have a musculoskeletal disorder, a sign of “unnecessary or inappropriate use.”

Researchers involved in the current study, published in JAMA Network Open, reached a similar conclusion that muscle relaxants are overprescribed.

“Despite increasing prevalence and increasing risks of their use, our systematic review suggests only limited evidence of efficacy for long-term use of SMRs for a small subset of pain syndromes,” wrote lead author Benjamin Oldfield, MD, an Assistant Clinical Professor of Internal Medicine at Yale School of Medicine.

“Evidence for effectiveness was strongest for SMRs used for muscle spasms, painful cramps, and neck pain; in studies of SMRs for fibromyalgia, low back pain, headaches, and other syndromes, some showed small benefits and some did not, and on balance studies did not suggest a benefit.”

Oldfield and his colleagues say physicians should consider deprescribing SMRs to pain patients who have been using them long-term without apparent benefit.   

Adverse side effects from SMRs include sedation, somnolence, dizziness and dry mouth. The FDA also warns against taking the drugs with opioids, which could raise the risk of respiratory depression and overdose.

SMRs also increase the risk of falls, fractures, and vehicle crashes. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

Why Autumn Weather Is Often Miserable for Pain Patients

Intellectually, I love the concept of a crisp autumn day. I love the idea of pumpkin spice lattes, crockpot chili, and cozy scarfs. But in practice, the intense temperature swings are pretty horrible for me every year.

The cool fall weather here in Northern Illinois is always devastating on my body. Indeed, my chronic pain has been 10/10 the last few days as the temperatures start their yearly drop, and it rains non-stop. 

It’s the same with spring too. Regardless of how much I’m longing for warmer weather every March, the shift from winter to summer means I spend most of the spring in too much pain to function. 

To me, it is obvious that these weather changes impact my pain. I’ve been dealing with it for more than a decade now. And every year, spring and autumn are especially bad. 

Surprisingly, the medical community still questions whether or not the link between weather and pain is real though – and if it is real, why it might be happening. 

“Research still hasn't confirmed a cause-and-effect link between weather and joint pain, though many people insist they can predict the weather based on such aches,” writes Toni Golen, MD, Editor in Chief of Harvard Women's Health Watch, in a 2022 article in Harvard Health,  

A 2015 study looked at whether daily weather conditions and changes in the weather influenced joint pain in older people with osteoarthritis in six European countries.

While they did find a causal link, they hesitated to call it a direct cause, saying that “the associations between day-to-day weather changes and pain do not confirm causation.”

In other words, researchers did not want to say outright that changes in the weather directly causes pain spikes. 

So I guess you’ll have to hear it from me instead: As a chronic pain patient, I can confirm that the effect is real, and it’s not in your head. Weather definitely causes pain spikes.

What might be causing it though? Golen explains that one theory is that changes in barometric pressure — which often happen as the weather changes — trigger pain in the joints. 

“Less air pressure surrounding the body can allow muscles, tendons, and other tissues around joints to expand,” she explains. “This can place pressure on joints, possibly leading to pain.”

Another theory is that cold, damp days make you more likely to do things that can worsen joint pain or stiffness, such as sitting on the couch too long watching movies. 

“Also, since you're expecting discomfort when the weather shifts, you may notice joint aches more than you would otherwise,” Golen adds. “To ward off weather-related joint pain, keep moving with regular exercise and stretching.”

I have to say, the second theory reads as a bit insulting to me. It sounds like health professionals are trying to find another way to blame patients for their pain. 

Personally, I also know that being sedentary is not the cause of my increased pain when the weather changes. That’s partly because when I wake up with pain in the morning, trying to shower and get out of the house quickly is likely to aggravate it. Also, as someone who works from home, I spend most of my days sitting down with a laptop and that usually doesn’t cause my pain to spike.  

As a chronic patient, I also don’t need a study to confirm my experience. I know weather changes cause a pain spike for me, and over the years I’ve learned to cope with it by accepting it. My life is set up so that most of the time, on bad pain days, I have the ability to rest as needed. 

When I first started having daily chronic pain, I would get very stressed about pain spikes, which would make them worse and harder to get under control. But now I know that keeping myself as calm as possible is the key to riding it out. 

I also know that it’s very likely that the pain will start to subside to more manageable levels after a couple of days at the most. And I know to take advantage of my low-pain days to get as much done as possible. In fact, I’m using one this week to write this column.

To me, the link between weather changes and pain spikes is so obvious, that I can’t even believe any doctors would still question it. If you’re among those struggling as the seasons change though, just know, I believe you. 

FDA Clears New Prescription-Only TENS Device

By Pat Anson

Transcutaneous electrical nerve stimulation – more commonly known as TENS – uses mild electric currents to temporarily relieve pain in sore muscles and tissues. Some TENS units are elaborate wearable devices that cost hundreds of dollars, while others are simple gadgets that can be purchased online or over-the-counter for about $30.

Due to lingering questions about their effectiveness, many health insurers don’t cover TENS devices, while others make patients jump through hoops to get reimbursed for them.

Medical device maker Zynex Medical is hoping to bridge the gap in insurance coverage with a new TENS device called TensWave, which is only available by prescription. The company says the FDA has “cleared” TensWave for marketing, allowing sales to begin immediately.

"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," Thomas Sandgaard, CEO of Zynex, said in a press release.

"We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand. It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients."

ZYNEX IMAGE

Unlike NexWave, which has three different electrical stimulation modalities, TensWave only uses TENS technology, which Zynex believes will make it easier to get insurance coverage. The company currently has no estimate of TensWave’s cost if a patient has to buy it out-of-pocket.   

In its press release, Zynex said TensWave “has been clinically proven to reduce chronic and acute pain,” which is a bit of an exaggeration, because the device did not go through the FDA’s lengthy review and approval process. However, because TensWave has “substantial equivalence” to other TENS units already on the market, it was cleared for sale without ever undergoing a clinical trial to prove its safety and efficacy. This is a common practice allowed by the FDA when new medical devices are introduced.

The World Health Organization takes a dim view of TENS, saying the evidence of its effectiveness in relieving chronic lower back pain is “very low” due to a limited number of clinical trials. In some trials, TENS worked no better than a placebo.

The UK’s National Health Service (NHS) has a similar view of TENS, saying there is not enough good-quality evidence to recommend its use as a reliable method of pain relief.

“Healthcare professionals have reported that it seems to help some people, although how well it works depends on the individual and the condition being treated,” the NHS states. “TENS is not a cure for pain and often only provides short-term relief while the TENS machine is being used.”

A Neurosurgeon’s Explanation of Why He Quit His Job Goes Viral

By Pat Anson

A former neurosurgeon who quit his job due to stress, anxiety, and a growing awareness that he wasn’t helping patients has become an internet sensation this summer.

“Dr. Goobie” (not his real name) posted a video on YouTube last month, explaining why he abandoned his practice and lucrative career performing surgeries on patients with chronic back problems.

“I had good partners. I had good hospitals that I worked at, but something was not right. I was very unhappy. On the surface, it didn't make sense. I was getting paid very well. It was a very well-respected job. I had good colleagues, had good support, but I was the most unhappy that I've ever been,” says Goobie, while on a hike swatting away mosquitoes with snowcapped mountains in the background.

Goobie’s video has gone viral with over 11 million views and nearly 64,000 comments, most of them expressing support for his decision to leave a high stress job in healthcare. His story is also a cautionary tale for anyone considering spinal surgery.

Goobie doesn’t give many personal details, but says he is 40 years old and lives in Washington state. He went to undergraduate school at the prestigious Massachusetts Institute of Technology (MIT), where he studied the potential for robotic arms and legs. When Goobie saw that wasn’t practical as a career, he enrolled in medical school to study neurosurgery.   

“Your job is to relieve suffering,” one of Goobie’s professors would say, an idealistic view of medicine that he shared and aspired to.

In practice, however, after his residency and nine years of performing surgeries, Goobie became disillusioned. It dawned on him that most of his patients with chronic back problems, like degenerative disc disease and spinal stenosis, weren’t getting better.

“I had learned all these fancy spine surgery techniques to do all this incredible surgery work through tiny cuts. It's called minimally invasive spine surgery,” Goobie explained. “I helped a lot of people out, but there were way more people that I couldn't help.

“There are so many people with back problems; neck pain, back pain, nerve pain down their arms and legs. Surgery might make them better for a little bit, but it didn't address what caused that disc to wear out, or the disc to bulge, or the joint to get loose, or the disc in between the bones to disappear, or the bones rubbing on each other. Surgeries don't address that.”

The Leaky Roof Problem

A colleague likened Goobie’s dilemma to a house with a leaky roof. Rain will ruin drywall and cause extensive water damage. You can replace drywall, take out moldy insulation and clean up the interior of a house, but if you don’t fix the leaky roof, the same problem will keep repeating itself.

“That's what I was doing. And the way I realized that is that I could do a perfect surgery, and some people would get better, some people would stay the same, and some people would get worse,” said Goobie.

“Some people would get better before I could operate on them. Even with gigantic bulging discs, they would get better. If I scheduled the surgery a month out, they would sometimes call me a week before surgery and say, ‘Hey Doc, you know my nerve pain is gone. Do I still need to do surgery?’ And that was very confusing to me.”

Why did some patients get better without surgery? Goobie started asking patients detailed questions about their lives and learned the ones who got better had low-stress, healthy lifestyles. They slept well, exercised regularly, had diets low in fat and salt, didn’t smoke, didn’t drink much, and had strong social networks.    

“DR. GOOBIE”

“And I saw that the people who did that, they would heal so quickly that I couldn't operate on them. I mean, sometimes I could, but if I was booked three or four weeks out, a lot of times people who were doing that, they would heal before I could do the surgery,” Goobie said.

“And the opposite was true. The patients that smoked like a chimney. They sat on the couch and they ate hot dogs all day. They had no friends. They were super stressed out. And they didn't sleep well. Those patients, I could do a really good surgery and I would get them temporarily better, but six months or a year later, the same part of their back would have a recurrent problem. Or a different part, a different joint in their back, would have a similar problem. And I would operate on them, and they might get better for six months, and then the same thing would happen. This is the leaky roof problem.”

The problem with the healthcare system, according to Goobie, is that it’s not designed to fix leaky roofs. It needs sick patients who stay sick.

“I'm not knocking any hospital or group that I worked with. I had the privilege to work with really amazing people in amazing hospitals, amazing institutions. But the way that everything is set up is that the hospital needs to make money. They need to grow economically,” said Goobie.

“The problem there is that if you figure out a way to help patients heal, in a way that doesn't include a pill or a surgery, then the hospital and the doctor are in big trouble. Because if you figure out a way to help people heal and you can't charge them for it, then you've just worked yourself out of a job.”

Hero or Snake Oil Salesman?

Other doctors applauded Goobie’s video, calling him “courageous” and “a hero” for speaking out.

“I really commend his approach to medicine and his goal of putting patient care and his own health first. That is not easy to do,” said Dr. John Y.K. Lee, who specializes in brain surgery.   

But some took offense at Goobie’s video, saying he made “numerous false claims” about the effectiveness of spinal surgery.

“He claims that degenerative spine changes can all heal with rest and nutrition, which is simply wrong,” Dr. Tyler Cole, a spinal neurosurgeon, said in a YouTube video of his own. “We all experience degeneration that can be delayed with good health, nutrition and exercise. But it is not magically reversed. You can’t regrow a disc that’s been worn down, despite what a YouTube snake oil salesman tells you.

“The biggest red flag is that he said his patients didn’t do well. If his patients aren’t doing well, it’s his own fault. Not every patient improves, but if a doctor is discouraged about many of his patients doing poorly, to the point of burning out, the doctor is to blame. It’s not some conspiracy to the point of making people sick.”

Goobie is currently unemployed and uncertain about his future. But he’s lost weight, sleeps better and feels much happier. He spends a lot of time outdoors hiking in the Cascade Mountains with his dog, Doobie.

He’s even launched a YouTube channel – appropriately called “Goobie and Doobie” -- in which he shares dozens of beautiful nature videos that feature bubbling streams, mountain meadows and high-altitude hiking..

“There are an infinite number of ways to go up the mountain and reach the peak. But there is only one peak,” Goobie explains. “We are all trying to get to the same place. It's okay to take different paths. We can all learn from each other.”

Goobie hopes his videos will help people sleep better, relax and refocus. It’s the prescription he learned from patients for his own healing.

“I found that hearing those nature sounds really helped; helped me feel better, helped me process what was going on better, be more present and aware, and release that stress and anxiety’” Goobie says. “That's how I came to where I am now. By letting go of neurosurgery, I am able to be outside and be healthier. My dog is able to live a fuller life, and I figured out a way that I can help relieve people's suffering.”

Just like his professor told him.

The Link Between Collagen Deficiency and Arachnoiditis

By Dr. Forest Tennant

A major finding in our studies of adhesive arachnoiditis (AA) is that most AA patients also have hypermobile Ehlers-Danlos syndrome (hEDS) or a related disorder now called hypermobile spectrum disorder (HSD).

AA is a chronic inflammatory condition that causes nerves in the spinal canal to form adhesions that “glue” them together, while hEDS and HSD cause deficiencies in collagen and the immune system.

How are these conditions connected?

Normal collagen is in thick strands that hold connective tissues together and helps resist infections, tearing, and autoimmune degeneration. When collagen is deficient, the strands may be thin, broken, shortened or non-existent. This allows viruses and bacteria to invade, infiltrating tissues and causing more infections than in individuals with healthy immune systems.

Spinal tissue normally contains considerable amounts of collagen, but in patients with hEDS or HSD they are weak and susceptible to deterioration, inflammation, adhesions and scarring. These spinal tissues include intervertebral discs, vertebrae, spinal canal cover (dura and arachnoid layers), ligaments, and cauda equina nerves.

Weaknesses in spinal tissue make persons with hEDS and HSD more susceptible to AA. It’s also not uncommon for them to develop one or more of these conditions before AA:   

• Tavlov cyst

• Spinal fluid leaks

• Chiari

• Tethered spinal cord

• Herniated disc

• Back pain

• Neck pain

• Spinal arthritis

We have found that persons with hEDS and HSD are also susceptible to Lyme disease, cytomegalovirus, herpes 6 virus, and especially the Epstein-Barr virus (EBV). Almost everyone has EBV, which is typically dormant, but the virus may reactivate from its parasitic life in throat membranes or lymphocytes to infiltrate the brain and spinal tissues.

Persons with hEDS or HSD who have back or neck pain for over 90 days should be screened with the new EBV 4 panel test and take measures to hopefully prevent AA. We highly recommended that they take collagen supplements.

In our studies of patients with MRI-documented AA, essentially 100% have EBV autoimmunity and about 70% show EBV reactivation. About half of those that we review do not know they have hEDS or HSD.

For more details on the link between AA, hEDS and HSD, our new book "The Ehlers-Danlos / Arachnoiditis Connection" is recommended.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis.

Readers interested in learning more about this research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can also subscribe to its bulletins here.  

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

FDA Approves Stem Cell Study for Degenerative Disc Disease

By Pat Anson

The Food and Drug Administration has given the go-ahead for a late-stage clinical trial of an injectable stem cell product that could give new hope to millions of patients suffering from lower back pain caused by degenerative disc disease (DDD).  Up to 400 patients with mild to moderate DDD are expected to enroll in the Phase 3 study later this year.

The trial is being conducted by DiscGenics, a Utah-based biopharmaceutical company that is developing new cell-based therapies for musculoskeletal conditions. It’s one of the first late-stage studies of a stem cell product to win approval from the FDA, which has been openly skeptical of cell-based therapies due to lack of evidence proving their safety and efficacy in clinical trials.

The only stem cell therapies currently approved by the FDA are used to treat sickle cell disease and some cancers. Approval of a stem cell product to treat degenerative discs would be a big step forward for regenerative medicine, and give patients an alternative to fusions and other more invasive spinal procedures.

“The FDA has been very familiar with our process, our product, and the chemistry, manufacturing and controls for quite some time,” says Flagg Flanagan, CEO and Chairman of DiscGenics. “We feel really good about where we are in terms of the patient reported outcomes. But most importantly about the safety. We feel like this cell is extremely safe to be used on human patients and we're feeling really, really good that we can help a lot of people.”

Discgenics’ injectable disc cell therapy (IDCT) is a single-injection biologic treatment designed to halt the progression of lumbar DDD by regenerating the disc “from the inside out.” The active ingredients in IDCT are enriched stem cells known as discogenic cells, which are derived from donated adult human disc tissue.

IDCT has been granted regenerative medicine advanced therapy and Fast Track designations by the FDA. Approval of the Phase 3 study came just weeks after Discgenics released positive results from a combined Phase 1/Phase 2 human trial of IDCT, published in the International Journal of Spine Surgery.

In that study, 60 patients with mild to moderate DDD were randomly assigned to receive an injection of either low-dose discogenic cells, high-dose cells, or a placebo. After one year, patients in the high-dose group had an average reduction in pain intensity of nearly 63 percent, along with significant improvements in their disability and quality of life. The regeneration of discs, which was monitored through MRIs and other imaging tests, was sustained two years after the injection.

“Things even came out a little better than we even expected,” Flanagan told PNN. “We showed very good durability, out to two years with the high dose patients. Anecdotally, we continue to follow some of those high dose patients and we have data in a pretty good cohort out to three years. We have a couple (patients) out to four years and the durability still seems to hold pretty well.”

The Phase 3 trial will consist of two parallel studies of IDCT that will also be randomized and placebo-controlled. Like the two earlier trials, each study will last for two years to assess the long-term safety and efficacy of IDCT. The first participants are expected to be enrolled in the final quarter of 2024.

“We'll start looking for patients and reviewing patient profiles that want to apply for the study shortly,” Flanagan said. “I think this is something where we can help many, many patients hopefully avoid a surgical intervention with an injection in a treatment room.”

People interested in getting updates on the Phase 3 IDCT trial or volunteering for it can submit their contact information to DiscGenics here.

Mesoblast, an Australian company specializing in regenerative medicine, recently began enrolling U.S. patients with chronic low back pain in a Phase 3 study of its proprietary mesenchymal stem cells, which are derived from young and healthy adult donors.

There’s Little Evidence That Massage Therapy Helps With Pain

By Crystal Lindell

It’s often touted as an alternative pain treatment, but it turns out there’s not much evidence showing that massage therapy actually helps with either chronic or acute pain. 

That’s according to new research published in JAMA Network Open that analyzed hundreds of clinical studies of massage therapy for pain. In a systematic review of those studies, the authors found little evidence that massage therapy actually helps relieve pain. In fact, most of the studies concluded that the certainty of evidence was low or very low. 

Notably, the researchers looked at studies involving many different types of pain, including cancer-related pain, chronic and acute back pain, chronic neck pain, fibromyalgia, labor pain, myofascial pain, plantar fasciitis, postpartum pain, postoperative pain, and pain experienced during palliative care. 

“There is a large literature of original randomized clinical trials and systematic reviews of randomized clinical trials of massage therapy as a treatment for pain,” wrote lead author Selene Mak, PhD, a researcher and program manager at the VA’s Greater Los Angeles Healthcare System. 

“Our systematic review found that despite this literature, there were only a few conditions for which authors of systematic reviews concluded that there was at least moderate-certainty evidence regarding health outcomes associated with massage therapy and pain. Most reviews reported low- or very low–certainty evidence.”

The results are especially concerning because massage therapy is often recommended as an nonopioid alternative for treating pain. In fact, in its revised 2022 opioid guideline, the CDC specifically mentions “massage” multiple times as a nonpharmacologic alternative. 

“Nonopioid therapies are preferred for subacute and chronic pain. Clinicians should maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient,” the guideline says.

Researchers involved in the current study found that “massage therapy” was a poorly defined category of treatment, which made it more difficult to analyze. For example, in some studies, acupressure was considered massage therapy, but at other times it was classified as acupuncture. 

“Massage therapy is a broad term that is inclusive of many styles and techniques,” Mak wrote. “This highlights a fundamental issue with examining the evidence base of massage therapy for pain when there is ambiguity in defining what is considered massage therapy.”

Researchers also found that it was difficult to do placebo-controlled massage studies because it’s difficult to compare massage with a sham or placebo treatment. 

“Unlike a pharmaceutical placebo, sham massage therapy may not be truly inactive,” they wrote. “It is conceivable that even the light touch or touch with no clear criterion used in sham massage therapy may be associated with some positive outcomes.… Limitations of sham comparators raise the question of whether sham or placebo treatment is an appropriate comparison group in massage therapy trials.”

The researchers said it might be better to compare massage therapy with other treatments rather than a placebo. They also called for more high-quality research to look into exactly how helpful massage therapy is for pain. 

All of this doesn’t mean that massage therapy offers zero benefits, and patients who get something out of it should continue to use it.  However, medical professionals (and guideline authors) should be more cautious about recommending massage as a substitute for proven pain treatments, such as opioids. Because the last thing people in pain need is to be given ineffective treatments while being denied effective ones..

Volunteers Needed for Arachnoiditis Study

By Pat Anson

Kathleen Haynes knows all about the physical and emotional pain that comes from adhesive arachnoiditis (AA), a progressive spinal disorder that causes severe intractable pain.  

She’s had AA for 50 years, after an oily contrast dye used for a myelogram imaging test was injected into her spinal column. The invasive test turned a simple back injury into a living nightmare, with the nerves in her lower spine becoming inflamed and sticking together.

“That oil stayed in my spinal column, surrounded my spinal nerves, and that’s why my nerves clumped together,” Haynes said. “And it just got worse and worse and worse, to the point where I use a wheelchair to get around.”

At the young age of 70, Haines is now pursuing a doctorate degree in Psychology at Walden University. For her dissertation, she’s doing a study about suicide ideation in AA patients. In the past, Haynes had suicidal thoughts herself.

“The pain was just unbearable. And not being believed that I was in pain and not getting the right medication,” she told PNN.

“One of the things that was a deciding factor in doing this study was because I belong to a couple of AA groups on Facebook. And I was struck by the amount of people who go on there and say they're suicidal or say can you please lead me to somebody who does euthanasia?”  

KATHLEEN HAYNES

Haines’ goal is to interview 10 people with AA in the next few weeks who are not currently having suicidal thoughts, but are willing to talk about them. To protect their privacy, participants will be assigned numbers and their real names will not be used. A list of other conditions and sample questions can be found here, along with Haynes’ contact information.  

It’s not the just the pain that makes AA patients suicidal, according to Haynes. Other common factors are being disbelieved, ignored or marginalized by family, friends and doctors. Thoughts about “ending it all” occur so frequently that she thinks every AA patient should be evaluated for suicide ideation.   

“I want to see what people's common denominator is, in talking to them about their suicidality. The goal is to get this study together and get it out to the medical community because they barely recognize AA, yet alone the suicidality their patients face,” she said.

“They need to treat their patients with AA in a way that gives them a desire to live. And get them the treatment team, the providers that they need in order to live fairly comfortable life, despite their pain.” 

Like many other AA patients, Haynes had trouble being believed. She suffered her initial back injury while working for the U.S. Postal Service in the 1970’s, but only recently did the federal government approve her workers’ compensation claim, even though her AA diagnosis and disability happened a long time ago. The Massachusetts woman is now getting appropriate treatment and pain medication.        

To learn more about Haynes’ study and/or make a donation to her research, visit her GoFundMe page.

The Best Remedy for Low Back Pain? Go for a Walk

By Pat Anson, PNN Editor

Almost everyone experiences low back pain at some point in their lives. Repeated episodes of acute low back pain are also very common, with 70% of people who recover from one episode having another one within a year.

Is there any reliable way to end the cycle before low back pain turns chronic?

A new Australian study suggests the best and most cost-effective way to keep low back pain from returning is simple: Go for a walk.

Researchers at Macquarie University’s Spinal Pain Research Group enrolled 701 adults who recently recovered from low back pain in a clinical trial. Half were randomly assigned to an individualized walking and education program led by a physiotherapist for six months; while the other half served as a control group, receiving no treatment at all.

Participants in the walking group were encouraged to walk five times a week for at least 30 minutes, but were free to do more or less. Most gradually increased their walking, with the average amount of walking time doubling in the first 3 months.

Both groups were then followed for at least one year, with researchers tracking any recurrences of low back pain lasting at least 24 hours that were severe enough to limit daily activities.

The study findings, recently published in The Lancet, show that participants in the control group had a recurrence of low back pain after 112 days on average, while those in the walking group were pain free nearly twice as long, a median of 208 days. The overall risk of having a new episode of low back pain fell by 28% for the walkers.

“We don’t know exactly why walking is so good for preventing back pain, but it is likely to include the combination of the gentle oscillatory movements, loading and strengthening the spinal structures and muscles, relaxation and stress relief, and release of ‘feel-good’ endorphins,” said senior author Mark Hancock, PhD, a Professor of Physiotherapy at Macquarie University.

"And of course, we also know that walking comes with many other health benefits, including cardiovascular health, bone density, healthy weight, and improved mental health.”

Another benefit is cost. A significantly higher percentages of participants in the control group sought treatment from massage therapists, chiropractors, physiotherapists and other healthcare providers.

While it’s hard to assign a dollar number to quality of life, researchers estimate the total cost-effectiveness of walking vs. no treatment at AU$7,802. In U.S. dollars, that’s $5,190.    

“It not only improved people’s quality of life, but it reduced their need both to seek healthcare support and the amount of time taken off work by approximately half,” said lead author Natasha Pocovi, PhD, a Postdoctoral Fellow at Macquarie University.

In 2023, the World Health Organization (WHO) released its first guideline for managing low back pain, recommending treatments such as exercise, physical therapy, and patient education. Pocovi and her colleagues say a regular program of walking would be a cheaper alternative to joining a gym or hiring a trainer.

“The exercise-based interventions to prevent back pain that have been explored previously are typically group-based and need close clinical supervision and expensive equipment, so they are much less accessible to the majority of patients,” Pocovi said. “Our study has shown that this effective and accessible means of exercise has the potential to be successfully implemented at a much larger scale than other forms of exercise.”

Low back pain is the leading cause of disability worldwide. According to a 2022 Harris Poll, nearly 3 out of 10 U.S. adults live with chronic low back pain. On average, the typical back pain sufferer seeks relief from at least three healthcare providers, with many treatments proving ineffective.   

Seniors Surprisingly Eager To Try Virtual Reality Therapy for Pain

By Pat Anson, PNN Editor

When it comes to using new technology or acquiring new skills, older people have a reputation for being a little slow on the uptake. A Baby Boomer nearing 70, for example, might not rush out to buy the latest iPhone, while someone from GenZ or a Millennial would.

A new study of virtual reality (VR) therapy is proving how misguided that assumption is. Older people can indeed learn new things and benefit from them.

In a secondary analysis of a placebo controlled clinical trial, people over 65 were significantly more likely to use RelieVRx, a virtual reality program that distracts patients with back pain by immersing them in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.   

A demographically diverse group of over 1,000 patients with chronic low back pain participated in the 8-week trial, with the goal of spending a few minutes at home each day watching a RelieVRx program.

By the end of the study, pain scores were reduced by an average of 2 points on a zero to 10 pain scale.

The positive results were across the board, regardless of a person’s age, sex, ethnicity, income or education.

What stood out to researchers is that seniors were significantly more likely to use the devices daily – 47 times on average – compared to those under age 65 (37.6 times)

APPLIEDVR IMAGE

“We had the opportunity to do a deeper dive, and really see how the results were unfolding in younger adults versus older adults, and really found very good engagement with older adults 65 or older,” says Beth Darnall, PhD, Chief Science Advisor for AppliedVR, which makes the RelieVRx headset and programming. 

“What's important about this study and also interesting is that it challenges a very common misperception about older adults. That older people are low tech, disinterested in engaging with newer innovations. We actually saw great engagement among the older adults, as well as a great reduction in symptoms. It suggests that older adults are much more receptive to this type of an approach and that it's also very effective in this population.” 

There are a few caveats to the findings. Many older people are retired and have more time on their hands to participate in a home-based study like this. And since all the patients were recruited online, they may have already been tech savvy enough to wear the VR headset and make it work for them.

RelieVRx is currently being used in hundreds of hospitals and in the Veterans Affairs (VA) system. Patients who’ve tried VR seem to like it, regardless of their backgrounds.

“The VA patients are generally pretty different than the rest of the civilian populations,” says Josh Sackman, president and co-founder of AppliedVR. “The usage is fairly consistent, even with a VA patient prescribed by a doctor who has no exposure to what VR is ahead of time.” 

VR therapy is a form of mindfulness or cognitive behavioral therapy. It doesn’t cure or relieve physical pain, but distracts patients long enough that their symptoms seem less severe. A 2022 study found that VR therapy has long-lasting benefits up to six months after treatment stopped.

The FDA has authorized the marketing of EaseVRx for chronic low back pain in adults, the first medical device of its kind to receive that designation. EaseVRx is only available by prescription and can’t be purchased directly by consumers.

In the coming months, AppliedVR hopes to expand coverage of the device through Medicare, Medicaid, and at least one large commercial insurer.

Evidence Lacking for Spinal Cord Stimulators

By Drs. Ian Harris, Adrian Traeger and Caitlin Jones

In an episode of the Australian Broadcasting Corporation’s “Four Corners” this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

People with chronic pain are suffering infections, shocks and even more pain from a device advertised as safe and effective. There are now calls for them to be recalled following a Four Corners investigation. https://t.co/qb1i0A47Lv

— ABC News (@abcnews) April 9, 2024

What Does the Evidence Say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”

.We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000 (US$ 32,542). With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry Influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

More than three million Australians are living with chronic pain, and it's become a breeding ground for exploitation.

Watch Four Corners: Pain Factory, now on ABC iview.#4Cornershttps://t.co/cZ9Qrt0Lsk

— ABC News (@abcnews) April 8, 2024

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners’ “Pain Factory” report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, MD, is a Professor of Orthopedic Surgery at University of New South Wales.  He is a practicing orthopedic trauma surgeon and directs a research unit specializing in surgical outcomes and the evidence base for surgery.

Adrian Traeger, PhD, is a Research Fellow at the Institute for Musculoskeletal Health at The University of Sydney. He is a physiotherapist who specializes in treating low back pain and other musculoskeletal conditions.

Caitlin Jones, PhD, is a postdoctoral research associate at the University of Sydney. Her research evaluates the benefits and harms of treatments for musculoskeletal conditions.

This article originally appeared in The Conversation and is republished with permission.

New Imaging Allows Doctors to Watch Spinal Cord During Surgery

By Pat Anson, PNN Editor

A new type of imaging technology could improve the effectiveness of spinal surgeries by allowing doctors to view high resolution images of the spinal cord during surgery.

The technology, known as fUSI or functional ultrasound imaging, is currently used to track neural activity in the brain. Researchers at the University of California Riverside (UCR) and University of Southern California say fUSI could also be used during back surgery to help doctors “see” the spinal cord in real time and how it responds to electrical stimulation. That could improve the success rate of spinal cord stimulators and other devices that use neuromodulation to dull pain signals.

“The fUSI scanner is freely mobile across various settings and eliminates the requirement for the extensive infrastructure associated with classical neuroimaging techniques, such as functional magnetic resonance imaging (fMRI),” lead author Vasileios Christopoulos, PhD, an assistant professor of bioengineering at UCR, said in a press release. “Additionally, it offers ten times the sensitivity for detecting neuroactivation compared to fMRI.”

Christopoulos and his colleagues reported in the journal Neuron that fUSI imaging was used on six people with chronic back pain who had partial laminectomies, a surgery that eases pressure on spinal nerves through the removal of bone or tissue. During the surgeries, clinicians also stimulated the patients’ spinal cords with mild electric signals to test the viability of fUSI.

Until now, it’s been difficult to assess whether a surgery for back pain is working because patients are asleep under anesthesia and cannot provide feedback on their pain levels. The motion caused by a patient’s heart and breathing may also interfere with MRIs and other imaging methods.

“These movements introduce unwanted noise into the signal, making the spinal cord an unfavorable target for traditional neuroimaging techniques,” Christopoulos explained. “With ultrasound, we can monitor blood flow changes in the spinal cord induced by the electrical stimulation. This can be an indication that the treatment is working.”

Images produced by fUSI are clearer and less sensitive to motion. It uses ultrasound waves to track the flow of blood in specific areas. Christopoulos likens it to a submarine that uses sonar to detect objects in the water.

“We have big arteries and smaller branches, the capillaries. They are extremely thin, penetrating your brain and spinal cord, and bringing oxygen places so they can survive,” he said. “With fUSI, we can measure these tiny but critical changes in blood flow.”

Spinal cord stimulators (SCSs) are invasive and have poor success rates. That’s why it’s customary for patients to go through a short trial period before having the devices surgically implanted. With improved monitoring of blood flow during surgery, Christopoulos hopes the success rate of SCSs will improve dramatically.

“We needed to know how fast the blood is flowing, how strong, and how long it takes for blood flow to get back to baseline after spinal stimulation. Now, we will have these answers,” Christopoulos said. “With less risk of damage than older methods, fUSI will enable more effective pain treatments that are optimized for individual patients.”

About 50,000 spinal cord stimulators are implanted annually in the U.S. The devices are often touted as an alternative to opioid pain medication, although a growing number of studies have questioned their safety and efficacy.

Lack of Awareness Is Harming People with Scoliosis

By Drs. Sanja Schreiber and Emily Somers

Cael was a typical 15-year-old — until the discovery of an already advanced abnormal curvature of his spine.

“I felt like the Hunchback of Notre Dame,” Cael told CBC News, recalling the emotionally draining and gruesome two-year wait for spinal surgery during which his curve progressed to a whopping 108 degrees.

Scoliosis is an abnormal twisting and curving of the spine that can develop at any age, but mostly occurs during rapid growth spurts in children, and as part of spine aging in adults over the age of 60.

Of all types of scoliosis in children, adolescent idiopathic scoliosis is the most prevalent, accounting for as many as nine in 10 cases and impacting up to one in 20 adolescents globally. On the other end of the age spectrum, a staggering two-thirds of older adults are also affected.

In clinical care, research and education related to scoliosis, disparities persist worldwide. Despite its widespread prevalence, scoliosis often goes undiagnosed, or has delayed diagnosis as in Cael’s case. It also receives limited attention in clinical and public health education, leading to significant gaps in health care.

This general lack of awareness has serious implications for thousands of people like Cael.

Gaps in Scoliosis Care

In the United States, fewer than half of states legislate school-based scoliosis screening in children. Even worse, Canada discontinued screening back in 1979 because it was not considered cost-effective.

Pediatricians’ screening practices vary, and some cases of scoliosis in children are only discovered when an unrelated chest X-ray reveals a curved spine. With about 30 per cent of cases being hereditary, parents may not recognize the signs early on.

The recommended care in North America involves bracing for mild to moderate curves (25° to 45°) and surgery for curves exceeding 45°. Shockingly, 32 per cent of Canadian children, like Cael, face delayed referrals, discovering significant curves when they finally see specialists.

Despite documented success in managing scoliosis through early screening, exercise rehabilitation and brace treatment, global health-care education often neglects this condition.

The general lack of global awareness leaves physicians, nurses and other practitioners unaware of effective treatments and referral processes, contributing to the misunderstanding and under-treatment of patients. Consequently, when children with scoliosis eventually reach specialists for care, they may encounter challenges navigating the health-care system as they transition into adulthood.

Sex Disparities

It is unclear why adolescent idiopathic scoliosis affects mainly girls. The more severe the curve, the more likely the patient is female.

Due to their specific biology, females also face a five-fold higher risk of progressive deformities and are 10 times more likely, compared to males, to require surgery.

Despite generally uncomplicated pregnancies and deliveries, women with scoliosis often face difficulties receiving pain control during labour, with higher epidural failure rates.

Moreover, they often suffer pregnancy-related back pain, and their spine curvature may worsen after pregnancy.

Healthcare Barriers

Healthcare access in the U.S. is influenced by a range of factors including race, income and health insurance coverage.

Patients with better insurance plans tend to seek pediatric orthopedic care at a younger age. Those with public insurance tend to have worse spine curvatures by the time they reach a scoliosis specialist; this is particularly striking among Black patients with public insurance, who are 67 per cent less likely to be diagnosed at a stage early enough for effective brace treatment compared to Black patients with private insurance.

While Canada’s health-care system covers spinal fusion for severe scoliosis, the lack of a national insurance program in the U.S. leads to varying out-of-pocket expenses for patients.

Those without insurance often cannot afford surgery at all.

But even with Canada’s universal coverage, patients typically wait an entire year for surgery due to a shortage of providers. Because of regional variability in resources such as access to spinal surgeons, funding and specialized facilities, some kids, like Cael, wait even longer, experiencing physical, emotional and psychological burdens, while their curves get progressively worse.

Delayed surgery in Canada cost the health-care system $44.6 million due to more complex surgeries, extended hospital stays, readmission and re-operation rates.

Lack of Research

Ongoing gender disparities in the healthcare workforce and lack of research funding for this female-predominant condition continue to hamper effective action.

Fewer than five per cent of spinal surgeons identify as women. Glass-ceiling effects surround women surgeons in this male-dominated culture, perpetuating gendered training environments, being held to higher standards and earning lower wages. The dearth of senior women role models and mentors is a further barrier for career advancement and retention.

Furthermore, research funding for diseases, such as scoliosis, that mainly affect females has historically lagged far behind funding for male-predominant diseases. Improving workforce diversity is an important facet of addressing health disparities and shaping research agendas.

Inequities abound in scoliosis care and research. The impact of lack of awareness and delayed care extends beyond physical challenges. The patient and their family suffer emotionally, incurring significant financial burden while fearing the future.

The message is clear, we must do better for this underserved population.

Sanja Schreiber, PhD, is an Adjunct Professor of Physical Therapy at the University of Alberta and the Owner/Director of Curvy Spine, a specialized clinic for treating structural spinal disorders and training physiotherapists in scoliosis rehabilitation.

Emily Somers, PhD, is an epidemiologist specializing in immune-mediated and musculoskeletal diseases. She also directs the Interdisciplinary Research & Team Science Program at the Michigan Institute for Clinical and Health Research.

This article originally appeared in The Conversation and is republished with permission.

New Physical Therapy Helps Older Adults with Chronic Low Back Pain

By Pat Anson, PNN Editor

Older adults suffering from chronic low back pain experienced faster pain relief after getting a new type of physical therapy focused on strengthening their hip muscles, according to a new study.

The study findings, recently reported in The Lancet Rheumatology, are notable given the limited research on back pain therapies for older adults.

“Unfortunately, the societal attitude is that older people don’t warrant the same level of care that younger people do when it comes to musculoskeletal problems,” lead author Gregory Hicks, PhD, Distinguished Professor of Health Sciences at the University of Delaware, said in a press release.

“When I started this work, there were a lot of naysayers. I’d tell them, ‘Read the literature — why are we excluding older adults from low back pain research?’ We all hope to get older. Why ignore a place in time where we all hope to end up?”

Hicks and his colleagues enrolled 184 people aged 60 or older who reported moderate low back pain, hip pain, and muscle weakness for at least 6 months. Patients were randomly assigned to a hip-focused physical therapy known as Manual Therapy and Strengthening the Hip (MASH) or a more traditional physical therapy for back pain that focused on the spine. Both groups received therapy for eight weeks at the University of Delaware, Duke University or the University of Pittsburgh.

Researchers found that participants who received the MASH therapy had more pain relief after eight weeks than those who had spine-focused therapy. They also showed more improvement in walking endurance and in their ability to rise from a seated position. However, after six months, both groups showed similar levels of improvement.

Previous research by Hicks, funded by the National Institutes of Health, has studied the impact of hip impairment, vitamin D deficiency, and trunk muscle composition in older patients with low back pain. He learned that there were distinct sub-groups of patients with back pain who had unique characteristics and treatment needs.

“It’s becoming quite clear, if you make the assumption that all low back pain is the same, you’re wrong,” said Hicks. “If you can identify sub-groups of low back pain patients with similar traits, you can develop matched treatments, which hopefully lead to better outcomes.”

Low back pain is the leading cause of disability worldwide. According to a recent Harris Poll, nearly 3 out of 10 U.S. adults currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with many treatments such as epidural steroid injections proving ineffective.