FDA Expands Use of Spinal Cord Stimulators to More Types of Back Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration continues to expand the use of spinal cord stimulators, despite a growing body of research that questions the safety and effectiveness of the devices.

This month the FDA approved the use of Abbott’s spinal cord stimulators for the treatment of chronic back pain in people who are unable to get corrective surgery – known as non-surgical back pain -- because they are too medically frail or have numerous degenerative disc problems. Those patients are usually treated with pain medication, physical therapy or spinal injections.

FDA approval was granted after a clinical study showed that SCS devices equipped with Abbott's BurstDR technology provided significant pain relief, better physical function, and improved quality of life in 200 patients with non-surgical back pain. The devices are surgically placed near the spine and emit mild electrical impulses to disrupt pain signals before they reach the brain. 

Participants in the study had chronic and disabling back pain for an average of nearly 13 years before getting the devices.

"We have struggled with how to treat people who weren't considered a good surgical candidate because we didn't have clear, data-driven treatment options for non-surgical back pain," Timothy Deer, MD, CEO of the Spine and Nerve Centers of the Virginias, said in an Abbott press release. "This new indication for Abbott's SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain."

BurstDR stimulation uses mild electrical pulses — or bursts — without creating an uncomfortable tingling sensation in the spine known as paresthesia.  All of Abbott's SCS devices use BurstDR technology.

Nine out of ten patients who received BurstDR therapy experienced significantly better function or pain relief, with pain levels reduced an average of nearly 70 percent. The improvements were sustained 12 months after the devices were implanted.

"This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott's goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery," said Pedro Malha, vice president of neuromodulation for Abbott.

SCS devices were long considered a treatment of last resort for people with severe back, neck and leg pain, but in recent years the FDA has expanded use of the devices for conditions such as painful diabetic neuropathy. The devices are often promoted as safer alternatives than opioid pain medication.

Recent research, however, has raised questions about the safety, efficacy and long-term benefits of the devices. A recent Cochrane review concluded the stimulators work no better than a placebo for treating chronic low back pain, and provide little or no improvement in quality of life.  In a review of 13 clinical trials, researchers found little clinical data on the long-term effectiveness of SCSs, and noted that most of the studies lasted less than a month, were poorly blinded, or funded by device makers.

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA.

A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. Other common adverse events are nerve damage, infections, and device malfunctions that may lead to further surgeries.

A 2022 study found that patients who get the devices did not reduce their use of opioids, and continued getting medical procedures such as injections, epidurals and radiofrequency ablation.

FDA Authorizes Smartphone App for Fibromyalgia

By Pat Anson, PNN Editor 

The U.S. Food and Drug Administration has authorized the marketing of the first smartphone-based digital therapy for fibromyalgia. The Stanza mobile app doesn’t relieve the physical pain of fibromyalgia, but is designed to help patients manage the anxiety, depression and other psychological symptoms that often come with fibromyalgia.

Fibromyalgia is a poorly understood condition characterized by widespread body pain, headaches, fatigue, insomnia and mood disorders. The FDA has approved only three medications for fibromyalgia -- duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica) – but many patients consider the drugs ineffective or have too many side effects.

“This represents a major milestone both for our company and the fibromyalgia patients we serve, and is a big step towards meaningfully addressing patient access barriers by making evidence-based, non-drug treatments available to more people,” said Mike Rosenbluth, CEO of Swing Therapeutics, the maker of Stanza.

“On top of dealing with the debilitating symptoms, fibromyalgia patients have been historically underserved and even stigmatized. Current FDA-approved medications, while offering moderate efficacy, are often accompanied by side effects.”  

The Stanza app provides training in acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), to help patients develop flexibility and resilience in coping with fibromyalgia. ACT teaches mindfulness strategies and behavioral changes to help people accept and manage their pain.

In a clinical trial, Stanza significantly reduced depression and anxiety in fibromyalgia patients, while improving their quality of life. About 80% of patients responded to Stanza therapy and the benefits were sustained for up to 12 months.

Stanza is designed to be used five to seven days per week, for about 15 to 20 minutes a day, over a 12-week period. After 12 weeks, the app can be used as needed.

Stanza is only available by prescription. It was first made available last year under the FDA’s Digital Health Enforcement Policy for Digital Health Devices. Swing Care, an online clinic that provides personalized treatment of fibromyalgia, includes Stanza as an option for patients in Texas. Swing Therapeutics anticipates that Stanza will also be available through Swing Care in other states later this year.

Staying Socially Connected Can Help With Chronic Pain

By Jill Suttie, Greater Good Science Center

Many people live with chronic pain. Whether it’s from injury or illness, chronic pain can affect a person’s mood, relationships, work productivity, and more, making it difficult to enjoy daily life.

Unfortunately, getting pain relief can be a complex process. One reason is that it involves both physiological and social-psychological factors — meaning, pain doesn’t just come from having a fever or breaking your arm, but other things happening in your brain, body, and environment. For example, your experience of pain can be lessened by things like distraction, listening to music, or practicing mindfulness meditation.

As researcher Laura Case of the University of California, San Diego, explains, “There’s no one-to-one relationship between activation of sensory nerves and your experience of pain or touch… Though there’s debate about which brain areas correspond to our final pain experience, all of the main players are interconnected with cognitive and emotional brain areas.”

Now a new study that she coauthored with Jennifer Baumgartner suggests another potential influence on pain: feeling socially connected.

A Sense of Belonging Helps

This new study reanalyzed measures collected in an earlier study, in which a group of chronic pain sufferers had been randomly assigned to an intervention shown to reduce pain (sleeping with a heavily weighted blanket) or to a control condition (sleeping with a slightly weighted blanket, which is considered non-therapeutic). After sleeping with their assigned blanket for a week, changes in people’s pain levels were assessed, and the two groups were compared to each other.

In the earlier study, the pain sufferers had also reported on their anxiety and depression symptoms, levels of loneliness, and sense of social connectedness—not how many social connections they had currently, but how generally close they were to other people and how strongly they experienced a sense of belonging. But these had not all been analyzed to see how they related to pain and pain relief from the blankets. That’s where the new study came in.

The new findings showed that people who were more socially connected experienced less pain than those who were less socially connected. After taking into account differences in expectations for pain relief and people’s initial pain levels, those who were socially disconnected felt more pain relief from the weighted blanket than from the lighter blanket, while more socially connected people received equal pain relief from both blankets.

For Baumgartner, these findings suggest that having a sense of belonging provides some level of protection against pain, regardless of any blanket intervention.

“Social support is really important for things that could potentially be threatening, such as stress or pain,” she says. “Having an internalized feeling of being connected with people has an effect on our physical sensations.”

Why would a sense of belonging help with pain? Neither Case nor Baumgartner is sure why.

However, in their study, people who were more socially connected had less anxiety, which could be a factor. Socially connected people probably feel safer and less anxious, says Baumgartner, because they know they can lean on others for support when they’re hurting. Less anxiety means less vigilance around unpleasant bodily sensations, which could decrease their experience of pain.

“Anxiety is strongly coupled with pain, exacerbating people’s surveillance of pain within their body,” she says. “So, having less anxiety is protective—no matter what intervention you receive.”

Case, who studies tactile sensations, says that positive social touch — like receiving a friendly hug or massage — has been shown to reduce pain sensation, and people who are more socially connected likely experience more of those types of touch. Someone who doesn’t have that in their lives much may crave soothing tactile pressure, which is why the weighted blankets can help somewhat.

“If you have difficulty feeling close to others, maybe there are some sensory ways to get around that and help your pain,” she says. “Deep pressure is calming, because it’s associated with the safety of being close to someone else, of being held and protected.”

The Power of a Big Hug

Surprisingly, feelings of depression didn’t seem to affect the relationship between social connection and pain, even though depression has been tied to pain in other research. While this study’s finding might prove to be an outlier, it could also suggest that the hyper vigilance accompanying anxiety is more impactful on pain than feeling down.

Either way, it appears that social connection matters when it comes to pain. However, that can’t be manipulated in an experiment. Baumgartner explains that this trait tends to develop early in childhood and may be tied to general attachment styles (secure, anxious, or avoidant). Since these are not easily changed, it’s good to have a useful, non-pharmacological treatment for pain relief in those without good social connectivity, like the weighted blanket.

“The weighted blanket doesn’t involve any sort of social situation at all, but it still seems to have the ability to help people, to some extent,” says Baumgartner. “Though there haven’t been enough rigorous studies done yet, I’m pretty optimistic that a weighted blanket could serve as an alternative or an adjunct to pain treatment—or maybe even a strategy to prevent people from getting chronic pain in the first place.”

Case says that it could substitute in some ways for what’s missing for people when they tend to be avoidant of others.

“Just anecdotally, people [in the study] found a weighted blanket tended to make them feel like they’re getting a big hug, and it’s relaxing and calming,” she says. “A weighted blanket isn’t a cure for chronic pain, and it’s not going to help everyone. But some people in our study did find it valuable.”

Case and Baumgartner’s study adds to a growing body of research showing how important social connectedness and social touch are for our health and well-being — something that’s been getting more attention in recent years. In fact, in a recent advisory report, the U.S. Surgeon General, Vivek Murthy, argued that our country is facing a “loneliness epidemic” that is affecting our health and longevity and that we need to create more opportunities for people to connect and build a sense of belonging in their lives.

Now, we know that social connection may also help those who suffer from chronic pain.

“Psychosocial factors are not peripheral to someone’s sense of chronic pain; they are central,” Baumgartner says. “Connecting with people and seeking out positive, healthy connections within your social environment is critical.”

This article originally appeared on Greater Good, the online magazine of the Greater Good Science Center at UC Berkeley.

Colostrum: A Regenerative Hormone for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

Persons with adhesive arachnoiditis (AA) and other severe painful conditions such as Ehlers-Danlos syndrome (EDS) have multiple tissues that become damaged, painful and dysfunctional.

Healing those damaged tissues and reversing the pain and neurologic impairments will require regenerative hormones. This is in contrast to other types of hormones that control inflammation (cortisone), metabolism (thyroid) or sexual functions (estradiol).

The human body makes some natural regenerative hormones, and they are now available for clinical use. Our first realization of their value in treating AA was with human chorionic gonadotropin (HCG). Other regenerative hormones that can be used to treat AA include colostrum, pregnenolone, dehydroepiandrosterone (DHEA), nandrolone, and human growth hormone (HGH). We have used all of these and believe that persons with AA should use at least one of them. But our first choice is colostrum.

Colostrum is in mother’s milk produced during the first few days after birth. It contains high levels of tissue growth factors, anti-inflammatories, pain relievers, and anti-infectious agents. Its natural purpose is to allow the newborn baby to initiate growth, protect against infection, and provide pain relief from the trauma of birth.

Colostrum supplements are sold by a number of companies and are usually made from the milk of cows that have recently given birth. Colostrum is recommended for use at least 3 to 5 days a week by persons with AA or EDS, who may wish to double the labeled recommended dosage. Colostrum is non-prescription, relatively inexpensive, and has few side effects. It can be taken with opioids and other drugs.

Regenerative hormones work best when they are used simultaneously with a high protein diet, collagen or amino acid supplements, vitamin C, B12, and polypeptides.

If a person with AA is not doing well or deteriorating, we recommend adding a second regenerative hormone such as nandrolone. A significant reversal of AA symptoms may require one or more regenerative hormones.

Several times a week we get inquiries from people who have just been diagnosed with AA and are pleading for information on what to do. 

The Tennant Foundation recently published an inexpensive short handbook for persons with newly diagnosed AA that gives a step-by-step plan that can hopefully slow progression of this disease.

If you have had AA for a while and aren't doing well, you may still benefit from some of our most up-to-date knowledge and recommendations in the “Handbook for Newly Diagnosed Cases of Adhesive Arachnoiditis.”

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Tennant Foundations’s Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

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

Should I Laugh or Should I Cry?

By Mia Maysack, PNN Columnist

Right now, I’m having one of those moments when the pain level is so high, it's almost unbelievable. It made me remember when a fellow chronically ill friend shared a story about her time in a grocery store.  She said that it felt as though a knife was cutting her open, all while she was just attempting to buy a few things.

Her response to this experience was laughter!

Perhaps you've heard the saying, "Should I laugh or should I cry?" Personally, I feel as though there's something to that. As I write this, I'm turning to the written word as my savior and deliverer from the wretched flare I'm in the midst of. I can barely see, let alone keep thoughts straight in my mind. But I'm choosing to smile, at least on the inside, because I'm thinking of my friend.

She said she laughed because it was comical in that moment -- her essentially feeling like the walking dead but having to function normally in a public place. No one else in the store could possibly know the inner crisis she was having. 

I can attest to this sort of thing making me feel a little crazy. Perhaps what helps to push us toward the bright side is the madness that's produced along the way. 

It’s been said that laughter is the best medicine. I've yet to have an ailment cured by laughing, but it's important to remember that despite our health or hardships, we possess a playful side. We are more than just a condition or diagnosis, there are other aspects of our identities. We're not what has occurred to us; what we are becoming is a result of our choice.

I'm choosing to laugh about the fact I've been attempting to get in touch with a provider, but cannot seem to get a call back. A previous appointment with the provider was so draining it left me feeling worse than I did upon arrival. It's all a reminder of how much it took to reach out to the provider in the first place, and the countless other let downs when the healthcare system falls short, which is most of the time. Healthcare is a joke and patients are often the punchline.

A common response to a person who is struggling is to advise them to seek help. That is a valid suggestion, but if “help” is the remedy, then it must be available and within reach.

We need to see what we need within ourselves, not to solely exist, but to excel in our experiences -- as opposed being dependent on systems that don’t serve our interests.

An example:  Recently when the exact opposite thing I felt like doing was grinning, I beamed in an effort to trick my brain into stimulating an increase in endorphins. This technique is readily available to me at any point, plus it’s free and doesn’t cause any adverse side effects! 

Laughter is another great way to assist in boosting mood, as is exercise to any extent that’s doable. The idea is to consciously work to counteract the pain signals that are firing as best we can, while living with unmanageable pain of one sort or another. 

Presently, I am choosing to be mentally mindful and to rejoice in breathing. This is how I prevail. I also find solace in knowing that what I’ve already endured will give me the strength I’ll need to face whatever is coming. Until then, I’ll strive to greet every moment that tests me with a smile. 

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

How to Manage Dental Care with Chronic Pain

By Dr. Michael Cooney, Guest Columnist

More than 75 percent of the chronic pain patients we have treated also suffer from chronic dental issues. Apprehension about dental care from our neuropathic pain community is certainly understandable. But bypassing care of your teeth, gums and mouth can allow potential problems to grow and ultimately become more painful when treatment is no longer an option. It then becomes a necessity.

I sought out the advice of a dentist who specializes in treating people with chronic pain conditions and asked him for dental hygiene maintenance and treatment guidance. Here’s what he told me.

Do I Need a Special Dentist?

First, take time to perform due diligence in locating a dentist who treats patients with chronic nerve pain and understands your special needs. Once you’ve found one, ask about specific tools, techniques and anesthesia options to help minimize and control any potential pain before and after your dental treatment.

One unfortunate byproduct of chronic pain management is the common use of medications. Be sure to address your medication use with the dentist beyond just listing them on your intake forms. These medications commonly contribute to xerostomia (dry mouth). Without adequate saliva, tooth decay and gum disease are more likely to flourish, and also cause:

• Interference with normal swallowing

• Taste disorders (dysgeusia)

• Speech difficulty

• Inability to maintain oral tissue integrity

• Mucositis (chronic mouth irritation and inflammation)

• Dental decay

• Erosion

To combat dry mouth, hydrate your mouth by sipping water throughout the day. Chewing sugarless gum can also help. You may also wish to use a moisturizing mouth spray.

Periodontal Disease

Over time, gums can pull away from the teeth and form pockets which become infected. The body’s immune system fights the bacteria as plaque spreads and grows below the gum line. Bacterial toxins and the body’s natural response to infection start to break down the bone and connective tissue that hold teeth in place.

If not treated, the bones, gums and tissue that support the teeth are destroyed, requiring the diseased teeth to be extracted.

Understandably, people with chronic pain want to avoid potential pain triggers, including during dental visits. So when tooth or gum pain or sensitivity presents, it is often in the latter stages of decay when the tooth cannot be salvaged. The unfortunate result is the need to remove the tooth.

Best Defense Is a Strong Offense

At home, brush your teeth a minimum of twice daily and floss. Yes, we know flossing is gross, but isn’t it better to get that stuff out of your mouth and into the garbage?

Give your tongue a good brushing to remove bacteria that leads to plaque and chronic bad breath. Twice-yearly teeth cleanings and exams are also necessary to prevent and offset any issues before they become more serious and require more invasive treatment.

Before your visit, talk with your treating physician to determine any special protocol or medication requirements needed. Be sure that your doctor and dentist are in touch to fully understand the nature of your care needs.

After cleaning or dental treatment, allow extra time to rest and recover. Eat soft food for a few days and avoid foods (meats, popcorn, hard candy) that can potentially become lodged in those clean and disease-free pearly whites!

Preventing dental disease can improve holistic health, allowing your immune system to perform at its optimal level and provide the highest quality of daily life possible.

Michael Cooney, DC, is Clinical Director of Calmare NJ.  He is one of the original Calmare certified providers in the U.S. to use scrambler therapy to significantly reduce or alleviate treatment-resistant neuropathic pain.

Cooney specializes in treating children, adults and seniors battling medication and treatment-resistant neuropathy due to fibromyalgia, CRPS / RSD, diabetes, shingles (PHN), post-surgical pain and pain after chemotherapy (CIPN).

Retraining Your Brain Can Reduce Pain

By Dr. Joshua Pate, University of Technology Sydney

For every feeling we experience, there is a lot of complex biology going on underneath our skin.

Pain involves our whole body. When faced with possible threats, the feeling of pain develops in a split second and can help us to “detect and protect.” But over time, our nerve cells can become over-sensitized. This means they can react more strongly and easily to something that normally wouldn’t hurt or would hurt less. This is called sensitisation.

Sensitisation can affect anyone, but some people may be more prone to it than others due to possible genetic factors, environmental factors or previous experiences. Sensitisation can contribute to chronic pain conditions like fibromyalgia, irritable bowel syndrome, migraine or low back pain.

But it might be possible to retrain our brains to manage or even reduce pain.

Our body senses possible threats via nerve endings called nociceptors. We can think of these like a microphones transmitting the word “danger” through wires (nerves and the spinal cord) up to a speaker (the brain). If you sprain your ankle, a range of tiny chemical reactions start there.

When sensitisation happens in a sore body part, it’s like more microphones join in over a period of weeks or months. Now the messages can be transmitted up the wire more efficiently. The volume of the danger message gets turned way up.

Then, in the spinal cord, chemical reactions and the number of receptors there also adapt to this new demand. The more messages coming up, the more reactions triggered and the louder the messages sent on to the brain.

And sensitisation doesn’t always stop there. The brain can also crank the volume up by making use of more wires in the spinal cord that reach the speaker. This is one of the proposed mechanisms of central sensitisation. As time ticks on, a sensitised nervous system will create more and more feelings of pain, seemingly regardless of the amount of bodily damage at the initial site of pain.

When we are sensitised, we may experience pain that is out of proportion to the actual damage (hyperalgesia), pain that spreads to other areas of the body (referred pain), pain that lasts a long time (chronic or persistent pain), or pain triggered by harmless things like touch, pressure or temperature (allodynia).

Because pain is a biopsychosocial experience (biological and psychological and social), we may also feel other symptoms like fatigue, mood changes, sleep problems or difficulty concentrating.

Neuroplasticity

Around the clock, our bodies and brain are constantly changing and adapting. Neuroplasticity is when the brain changes in response to experiences, good or bad.

Pain science research suggests we may be able to retrain ourselves to improve wellbeing and take advantage of neuroplasticity. There are some promising approaches that target the mechanisms behind sensitisation and aim to reverse them.

One example is graded motor imagery. This technique uses mental and physical exercises like identifying left and right limbs, imagery and mirror box therapy. It has been tested for conditions like complex regional pain syndrome (a condition that causes severe pain and swelling in a limb after an injury or surgery) and in phantom limb pain after amputation.

Very gradual exposure to increasing stimuli may be behind these positive effects on a sensitised nervous system. While results are promising, more research is needed to confirm its benefits and better understand how it works. The same possible mechanisms of graded exposure underpin some recently developed apps for sufferers.

Exercise can also retrain the nervous system. Regular physical activity can decrease the sensitivity of our nervous system by changing processes at a cellular level, seemingly re-calibrating danger message transmission. Importantly, exercise doesn’t have to be high intensity or involve going to the gym. Low-impact activities such as walking, swimming, or yoga can be effective in reducing nervous system sensitivity, possibly by providing new evidence of perceived safety.

Researchers are exploring whether learning about the science of pain and changing the way we think about it may foster self-management skills, like pacing activities and graded exposure to things that have been painful in the past. Understanding how pain is felt and why we feel it can help improve function, reduce fear and lower anxiety.

Don’t Go It Alone

If you have chronic or severe pain that interferes with your daily life, you should consult a health professional like a doctor and/or a pain specialist who can diagnose your condition and prescribe appropriate active treatments.

In Australia, a range of multidisciplinary pain clinics offer physical therapies like exercise, psychological therapies like mindfulness and cognitive behavioural therapy. Experts can also help you make lifestyle changes to improve sleep and diet to manage and reduce pain. A multi-pronged approach makes the most sense given the complexity of the underlying biology.

Education could help develop pain literacy and healthy habits to prevent sensitisation, even from a young age. Resources, such as children’s books, videos, and board games, are being developed and tested to improve consumer and community understanding.

Pain is not a feeling anyone should have to suffer in silence or endure alone.

Joshua Pate, PhD, is a Senior Lecturer in Physiotherapy at University of Technology Sydney. He is on the Scientific Program Committee for the Australian Pain Society.

Josh’s research focus is on childhood pain. He is the author of a series of five books designed to help children learn and talk about pain, called Zoe and Zak's Pain Hacks.

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

Melatonin and Cannabis Products Often Mislabeled

By Pat Anson, PNN Editor

If you use cannabis for pain relief or take melatonin to help you sleep at night, you may want to check the label and ask the manufacturer just how accurate the list of ingredients is.  Or think twice before buying it.

Two more studies are raising doubts about the accuracy of label claims on cannabis products and melatonin supplements, which are often marketed with unsupported claims about their health benefits.

In the first study, published this week in JAMA, researchers analyzed 25 melatonin gummy products, including 5 gummies that also contained cannabidiol (CBD). Melatonin is a natural hormone produced by the brain at night to help induce sleep. Supplements containing synthetic melatonin and/or CBD are often marketed as products that improve sleep, reduce anxiety, and promote relaxation.

Researchers found that only 3 of the 25 gummies contained enough melatonin to be within 10% of the labeled amount – with one product containing 347% more melatonin than what was listed, a potentially dangerous amount. Another gummy contained no melatonin at all, just CBD.

“The great majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD,” wrote lead author Pieter Cohen, MD, an associate professor at Harvard Medical School and an internist at Cambridge Health Alliance. “Given these findings, clinicians should advise parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and CBD.”

Pediatric use is concerning because calls to U.S. Poison Control Centers about children ingesting melatonin have increased five-fold over the past decade, resulting in nearly 28,000 emergency room visits, over 4,000 hospitalizations and two deaths.

Researchers say it takes just 0.1 mg to 0.3 mg of melatonin to increase plasma levels beyond the normal nighttime range in young adults. The amount of melatonin found in the gummies was much higher, including one product containing 13.1 mg of melatonin.

“Consuming melatonin gummies as directed could expose children to between 40 and 130 times higher quantities of melatonin,” they said. “With respect to CBD, the drug is FDA approved to treat refractory seizures caused by 3 rare genetic disorders, but the FDA has not approved the use of CBD for any indication in healthy children.”

The JAMA report is believed to be the first U.S. study to quantify the amount of melatonin in over-the-counter supplements. A 2017 Canadian analysis of melatonin products had similar findings, with the actual dose of melatonin ranging from 17% to 478% of the amount listed on the label. Neither the U.S. or Canadian studies identified the melatonin brands that were tested.

Too Little THC

It wasn’t too much, but too little tetrahydrocannabinol (THC) that University of Northern Colorado researchers found in 23 cannabis flower products purchased at state-licensed dispensaries. The study findings, recently published in the journal PLOS One, show that nearly 70% of the flower samples had THC levels at least 15% lower than what was listed on their labels.

Inaccurate labeling has long been a problem in the cannabis industry. Some growers and merchants resort to “lab shopping” to seek out product testing laboratories that generate the most desirable results – which means inflated levels of THC.  There’s a financial incentive to do so, because cannabis products containing high amounts of THC usually sell at a higher price.

One of the flower samples, purchased at a Denver dispensary and sold under the brand name “OG Kush 2,” had only half the amount of THC listed on its label.  

“Given our results it is urgent that steps are taken to increase label accuracy of Cannabis being sold to the public. The lack of accurate reporting of THC potency can have impacts on medical patients controlling dosage, recreational consumers expecting an effect aligned with price, and trust in the industry as a whole,” researchers said.

“Although we have no power to change the current system, we hope highlighting this issue and educating consumers will affect the change needed to remedy inflated potency of flower products. Addressing this discrepancy will require both changes to the regulatory system and consumer awareness that reported THC potencies are frequently inflated.”

Although 38 states and Washington DC have legalized medical or recreational cannabis, there is little consistency in labeling, regulating or testing cannabis. The researchers called for more regulatory oversight of cannabis and standardized testing protocols.

6 Tips for Healthier Living with Chronic Pain

By Barby Ingle, PNN Columnist

People with chronic pain-related medical conditions are at higher risk for infection, falls, poor posture, complications, mental health issues and other challenges. There are things we can do to help lower these risks and live fuller, longer, happier and healthier lives.

Tip #1: Have good communication with your medical providers. Your medical team can include specialists in primary care, pain management, rheumatology, dentistry, ophthalmology, gastroenterology, gynecology, podiatry, surgery, physical therapy and nursing. The more proactive you are in communicating with your providers, the better and faster they can assist you in proper care.

Tip #2: Keep your weight under control. Maintaining an ideal weight as a pain patient can be difficult. You can lose your appetite and not eat enough, or overeat to help deal with the stress of being ill. You may even have cravings for goodies because the pain is so bad. We need something good in our life, right?

Maintaining a good body weight can be very helpful. I use the Noom healthy eating app, gut health testing through Viome, and self-discipline to better control my weight. I watch what I eat and look for healthy treat items that I can enjoy when others around me are having their goodies, helping me to stay social.

Healthy eating needs to be individualized. What is good for me to eat is not always good for others. Find your dietary recommendations and stick to them whenever possible.

Tip #3: Drink plenty of water. I know, I know. Water can be so dull. But drinking the right amount of water increases your energy and helps you focus more. Improved concentration and memory enable you to take on more in life and stay active.

Drinking water can also help you feel fuller and avoid overeating. Water flushes out toxins that we build up from high pain levels, the environment, and other lifestyle choices. Good hydration improves your skin texture, helps it stay elastic and makes you look younger. 

Tip #4: Exercise regularly. I know it’s much easier said than done. Even if you just reduce your sitting and screen time, making the change can help. Know your physical boundaries. For example, if you have a catheter and are not supposed to lift over 10 pounds, don’t do it. Stick to simple household tasks, such as moving the clothes from the washer to the dryer or engage in light sweeping.

During the pandemic, I started doing stretches and light yoga moves while watching TV. Many great exercise shows can be found on television, YouTube and the Internet. Even if you cannot touch your toes like the person in the video can, you can still stretch in that position. Make it a goal to improve your range of motion. Goal setting and a plan of action can help improve vascular flow, blood pressure and other health benefits.

Tip #5: Improve your sleep. A good night’s sleep not only helps reduce pain, it improves your brain performance and mood, and helps lower the risk of heart disease, stroke and obesity. 

Tip #6: Do not smoke or drink to excess. Work to do it less and less each day. I know it’s hard, but I also know it is possible to limit yourself or even quit. 

None of these tips will cure pain. They are tools to help improve your daily living despite your pain. We are told them while growing up, but often life gets in the way and we need a reminder to check our self-care tools and improve the manageable areas of life.

Best wishes in all you do to live a happier, more productive and healthier life! 

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com.   

Online Health Programs Help Reduce Pain

By Pat Anson, PNN Editor

Online health programs can help patients with chronic pain conditions learn how to manage their pain and other symptoms, according to two new studies. One “e-health” program even helped patients reduce their use of opioids.

Online pain self-management programs have proliferated in recent years due to the pandemic and greater acceptance of telemedicine, but few studies have assessed their effectiveness. The programs provide content similar to what a patient might receive from a pain psychologist — in-person treatment that often is not accessible or affordable for everyone.

In a small study at the University of California, Irvine (UCI), researchers recruited sickle cell patients through advertisements on Facebook, Reddit and other social media sites. Sickle cell disease is a painful genetic disorder that primarily affects people of African or Hispanic descent. Many sickle cell patients face stigma when they seek treatment for pain flares and have learned to distrust the healthcare system.

“Before the study, we were told sickle cell researchers thought online outreach to patients would not work as patients wouldn't trust the process,” said Sean Young, PhD, a professor in UCI’s Departments of Emergency Medicine and Informatics. “Surprisingly, we found it worked really well.”

Researchers recruited 32 young adult patients with sickle cell to watch a 20-minute video that taught mindfulness meditation. Afterward, participants were emailed links to additional audio recordings for ongoing practice. Patients rated their pain intensity, anxiety and depression before and after the mindfulness training.

“Patients with sickle cell disease struggle with pain, and unfortunately, they have few options for relief,” said Young. “We developed and tested a brief online intervention to teach them mindfulness and found that it helped their pain both immediately and for six weeks after they viewed the mindfulness exercise.”

The study findings, recently published in the journal Cureus, show that after six weeks of mindfulness training, pain intensity declined an average of 1.3 points, anxiety decreased by 1.8 points, and depression declined by 1.7 points.

Researchers think younger sickle cell patients feel more comfortable participating in e-health programs. About 97% of participants watched the full mindfulness video and a little over half listened to additional recordings.

Reduced Opioid Use 

The second study of an e-health program, published in the journal Pain, involved over 400 pain patients on long-term opioid treatment who were recruited by researchers at Washington State University. Half the participants watched a pain self-management program and the other half received treatment as usual, serving as a control group.

Patients in the e-health group watched an online course designed by a psychologist, called Goalistics Chronic Pain Management, which aims to help people manage their pain through cognitive behavioral therapy, exercise and relationship advice, as well as information about opioid use and risks.

After six months, over half the patients in the e-health group (53.6%) were able to reduce their opioid dose by 15% or more, compared to 42.3% of patients in the control group.

There was not much change in pain levels in either group. Pain intensity declined by at least two points in only 14.5% of e-health participants, and in 6.8% of the control group.

"These were very encouraging findings: not only were they reducing opioids but also their pain was not becoming worse," said lead author Marian Wilson, PhD, an Associate Professor of Nursing at WSU. "Some people are hesitant to stop their opioid medication because they fear their pain will increase, but we found that at least on average in this population, they could reduce their opioids a bit and not have increased pain symptoms."

Wilson and her colleagues also observed the e-health patients improved their knowledge about pain, confidence in managing it, and their coping skills.

"The idea is to put the patient in the driver's seat because we can give them a prescription for opioids, and that will work for a little while, but over time for chronic pain, it's not usually going to be the solution to fix all their troubles," she said.

The Goalistics e-health program currently has a monthly $30 fee, which usually is not covered by insurance. In addition to pain management, Goalistics also has an online self-management program for depression.

Polypeptides: A Promising Treatment for Intractable Pain

By Dr. Forest Tennant, PNN Columnist

We have long noted that persons with adhesive arachnoiditis (AA) and other causes of intractable pain who follow a high protein diet and take amino acid supplements usually have better treatment outcomes. They need fewer opioids, function better, and have a good quality of life.

Protein is composed of about two dozen separate building blocks called amino acids. Once ingested, they chemically join together and cause specific effects in the body. When two or more amino acids combine and partner, they are called polypeptides. Two polypeptides that relieve pain and heal damaged tissue are KPV (lysine-proline-valine) and Body Protection Compound or BPC-157.

KPV is useful primarily for pain relief and to reduce inflammation in the brain and spinal canal. It activates the neurotransmitters endorphin and melanocortin, which are stored in the hypothalamus. 

BPC-157 is a chain of 15 amino acids. Its primary function is to regenerate and heal tissue, including neural tissues, receptors, arachnoid membrane, cartilage and intervertebral discs. We believe it also helps heal spinal fluid leaks. BPC has a great effect on the stomach and intestine. 

Because polypeptides (PP’s) are fundamentally a conglomeration of food particles, when swallowed they are digested in the stomach and lose much of their effectiveness. That is why KPV and BPC-157, like insulin, are often taken by subcutaneous injection. Both PP’s are also available in non-injection formulations. KPV comes in an oral or nasal spray, while BPC-157 is available as sublingual tablet taken under the tongue or as a spray. 

A list of several companies that supply PP’s online is available in this bulletin.  

Who Should Take Polypeptides  

We have long-recommended a three-component medical protocol for AA and other causes of intractable pain to (1) suppress inflammation and autoimmunity, (2) regenerate tissue and (3) relieve pain. Our starting protocol for AA is now changed and anchored with KPV and BPC-157.  

To start, we recommend daily use of a polypeptide for a week. After a week, use it 3 to 5 days a week. Some persons with AA like to use KPV daily as it greatly reduces pain. Others can become tolerant to polypeptides, so skipping some days will keep the polypeptide active and effective.  

All persons with AA and/or intractable pain should, in our opinion, try the two PP’s provided here to enhance pain relief, promote tissue regeneration and healing, and reduce the use of potent medications, including corticosteroids, ketorolac, benzodiazepines, and opioids.  We also believe PP’s can reduce the use of risky surgery and invasive procedures.  

Several other polypeptides are being studied, and the Tennant Foundation will keep you apprised of new discoveries and developments. We consider polypeptides a major advance in the treatment of AA and other intractable pain conditions. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Tennant Foundations’s Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

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

Finding a New Ketamine Provider

By Barby Ingle, PNN Columnist 

For me, treatment with ketamine was life giving and lifesaving. I started ketamine infusion therapy in 2009, flying back and forth to Pennsylvania for treatment at Drexel University Hospital. My doctor there, neurologist Robert Schwartzman (now deceased), did much of the initial research on ketamine as a treatment for Reflex Sympathetic Dystrophy (RSD), also known as algoneurodystrphy or complex regional pain syndrome (CRPS).

I was on the ground floor with ketamine as a pain treatment, and helped bring it to Arizona with providers like Drs. Steven Siwek, Eric Cornidez, Natalie Strand at the Pain Centers of Arizona and Freedom Pain Hospital, to name a few.

One of my favorite places to go was Ketamine Wellness Centers (KWC), which operated a nationwide chain of ketamine clinics until it abruptly shut down last week. I knew many of KWC’s staff members at their Arizona and Florida offices.

I was patient zero for KWC. I remember sitting with Gerald Gaines (now deceased) and Kevin Nicholson, the current CEO, and sharing with them how ketamine changed my life. I asked them to look into ketamine and start a clinic. They did. Kevin built up the business and eventually opened 13 clinics in 10 states before recently merging KWC with another company, Delic Holdings.

The merger hasn’t worked out due to financial issues. The clinic closures significantly affect access to care for chronic pain, depression and mental health in the communities they served. KWC was one of the only places that treated both pain and depression, using ketamine in conjunction with other modalities.

As a patient, I have been through clinic closures before and providers stopping their ketamine treatment for various reasons. Upon reflection, I have been to more than 10 clinics and had close to 20 providers since starting in 2009. It is scary to think that thousands of patients like me have to start the process all over again, but having been in this situation before, I know it can work out.

My message to the former patients of Ketamine Wellness Centers is that there is hope. It may be harder depending on where they live, but other options exist. I plan on getting the same treatment that I have since 2009. I was asked how to go about finding a new ketamine provider by another patient. My response is this:

1. Know your ketamine protocol and how it works for you

2. Call ahead of your consultation and say, “This is what I had. This is what I want. Can you do it?”

3. Don't settle for less. There are many ketamine providers now. Find the one that is a fit for you.

Getting this treatment is very personal, and you need a feeling of safety, comfort and trust. It is not just about getting your IV hooked up and going from there. You should be exploring your options, just like you did the first time with KWC.  Now you have experience and know what ketamine therapy is like. 

When I got this treatment for the first time from Dr. Schwartzman, my entire life changed for the better. I went into the hospital in a wheelchair. Seven days later, I walked out. It's helped with dystonia, strength, balance, coordination and more. The most significant area of success for me was the burning fire pain. I strive never to have that pain again. Receiving ongoing treatments helps me live with my daily chronic pain issues. 

I received my latest infusions at the Ketamine Wellness Center in Tucson a few weeks ago. At the time, I had no idea that KWC was about to shutdown. I know it's a shock to all of us former patients, and I'm worried about the employees and where they will go. Their knowledge and experience will be welcomed at other clinics.

Part of the problem with KWC is that they expanded too quickly when they merged with Delic. Ketamine treatment is not a cash cow for providers, but they can make a good living and help thousands of patients who rely on ketamine to relieve their pain, be it mental or physical.

I hear that there will be lawsuits due to KWC’s abrupt closure and lack of notice, the inability of some patients to receive their medical records, employees who have not been paid correctly, and other challenges that have come to light. This will all be sorted out. It will take time, but we already know it is worth the time, effort and energy to ensure we can receive the life-giving treatments. 

I still need to receive my medical records from KWC, but I have all of my records from other providers and have changed my treatment protocol. I am already in talks with new providers. I don't have time to wait around.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com   

Hypnosis Works Better Than Prayer as Pain Reliever

By Pat Anson, PNN Editor

When it comes to relieving acute pain, praying to God for help isn’t nearly as effective as a single session of hypnosis or mindfulness meditation, according to an unusual new study.

Intrigued by research that found Muslim prayer rituals reduce pain, an international team of researchers recruited 232 healthy adults in Portugal to further study the effects of spirituality on pain.

Short-term acute pain was induced in all participants by wrapping their arms and hands in a cold compress for up to 5 minutes. After a rest period, participants listened to either a 20-minute recording of guided hypnosis, mindfulness meditation, or a passage from the New Testament followed by a short Christian prayer. A fourth group listened to a reading from a natural history book and served as a control group.

After listening to the recordings, acute pain was induced again with a cold compress, while participants had their pain intensity, pain tolerance, cardiac function and stress levels monitored.

The study findings, recently published in the Journal of Pain Research, show that hypnosis was effective in lowering pain intensity and raising pain tolerance, followed closely by mindfulness meditation. The benefits from Christian prayer (CP) were small and not considered statistically significant.

“The findings suggest that both single short-term hypnosis and mindfulness meditation training, but not biblical-based CP, may be viable options for effective acute pain self-management,” researchers reported. “The findings also suggest that hypnosis might be slightly more efficacious than mindfulness meditation, at least in the short-term, and perhaps especially among novice individuals with very limited hypnosis or meditation practice/training.”

The research team was somewhat surprised by the lack of results for Christian prayer, and think it may have been due to the complexity of the bible-based prayer. A shorter, simpler form of prayer may have worked better. Another factor was that only a third of the study participants described themselves as Christian, while a third said they were atheists or agnostics.

“It is therefore possible that the prayer used in this study might have had a larger beneficial effect among those describing themselves as Christian than those describing themselves as being in one of the non-Christian groups and have had little (or even opposite) effect on atheists and agnostics. For the latter, prayer might have been bothering or even distressing, leading the individuals to focus more on the pain and on the distress caused by prayer itself,” researchers said.

Could Hypnosis Replace Opioids?

Previous studies have found that hypnosis and mindfulness can reduce acute pain in hospitalized patients, and that hypnosis can relieve chronic pain for patients with irritable bowel syndrome (IBS), complex regional pain syndrome (CRPS) and other intractable pain conditions.

A new study published in The Journal of Molecular Diagnostics even suggests that hypnosis can be an alternative to opioids in relieving post-operative pain.

Researchers at Stanford University say genetics play a role in “hypnotizability” — the tendency of some people to respond to hypnosis more than others — and developed a molecular diagnostic tool to identify individuals who would benefit from hypnosis through their blood and saliva samples. They believe the tool could be used as a “point-of-care” test in a hospital setting to determine how patients are treated for pain. Depending on the test results, a patient recovering from surgery could get “hypnotic analgesia” as an adjunct or alternative to pain medication.

“It is a step towards enabling researchers and healthcare professionals to identify a subset of patients who are most likely to benefit from hypnotic analgesia,” said co-lead investigator Jessie Markovits, MD, Department of Internal Medicine, Stanford School of Medicine.

“Precision medicine has made great strides in identifying differences in drug metabolism that can impact medication decisions for perioperative pain. We hope to provide similar precision in offering hypnosis as an effective, non-pharmacological treatment that can improve patient comfort while reducing opioid use.”

How TMS Helped Me Feel Better Physically and Mentally

By Madora Pennington, PNN Columnist

Chronic pain is often accompanied by depression. Many clinicians used to think that pain was caused by psychological distress, so they offered patients antidepressants with the attitude that their suffering was “all in their head.”

But now it is better understood that chronic pain can cause depression. Both conditions have a similar pathology and change the brain in similar ways. That is why treatments that work on depression (like antidepressants) may reduce the brain’s sensitivity to pain.

“Regardless of the cause of the pain, anxiety and depression increase the sensation of pain. Pain increases depression and anxiety, creating a vicious cycle. Breaking that cycle can help decrease pain,” says integrative physician and pain doctor Dr. Linda Bluestein.

I have Ehlers-Danlos Syndrome (EDS). Debilitating pain has been my companion since I was 14 years old. My body makes collagen that is not structurally sound. Because I am “loosely glued together,” I get injured easily because my joints are unstable and my body has a poor sense of where it actually is in relation to itself and the outside world. My thin and stretchy connective tissue sends pain signals to my brain, even when I am not injured.

It is probably not realistic for someone with Ehlers-Danlos to expect to have a life without pain, so I welcome medical treatments that might lessen my pain, even if they don’t eliminate it. My goal is to have pain that does not incapacitate me or ruin my life by taking all my attention. Thankfully, there are modalities that do this.

MADORA GETTING TREATMENT AT UCLA’S tms CLINIC

The last one I tried was transcranial magnetic stimulation (TMS), which stimulates the brain through a magnetic pulse which activates nerve cells and brain regions to improve mood.

TMS treatments are painless and entirely passive. The patient just sits there and lets the machine do the work. A magnetic stimulator rests against the head and pulses, which feels like tapping or gentle scratching.

TMS has been around for almost 40 years. The first TMS device was created in 1985 and the FDA approved it for major depression in 2008. Since then, its use has been expanded to include migraine, obsessive compulsive disorder, and smoking cessation.

While other medical procedures work on an injured body part, TMS targets the brain, where pain is processed. This helps the brain shift away from perceiving pain signals that are excessive and have become chronic.

“Many people are surprised to learn that stimulating the brain can help alleviate pain that is felt in an arm, leg or some other part of the body. We explain to patients that because pain is perceived in the brain, it is possible to reduce or sometimes even eliminate it by stimulating specific brain regions,” says Andrew Leucther, MD, a psychiatrist who heads UCLA’s TMS clinic, where I was treated. In addition to depression, the clinic also treats fibromyalgia, neuropathy, nerve injury, and many other causes of pain.

“Most patients are much less bothered by pain after treatment and report that they are functioning better in their work and personal lives,” Leucther told me.

Many insurers cover TMS for depression, but it is not generally covered for pain alone — although many doctors will add protocols for pain when treating depression. This is how I got my 36 sessions of TMS treatment, the usual number that insurance will cover and is thought to be effective.

Repetitive TMS stimulation to the primary motor cortex of the brain has robust support in published studies for the treatment of pain. It seems to work particularly well for migraines, peripheral neuropathic pain and fibromyalgia. Like all treatments, it may not work for everyone.

TMS practitioners recommend four or five sessions per week, gradually tapering off toward the end. My body is so sensitive, about three per week was all I could tolerate comfortably. The appointments lasted a brief 10 -15 minutes. A downside of the TMS machine is that it puts pressure against the head, which could be too much for Ehlers-Danlos patients who have uncontrolled head and neck instability.

TMS gave me relief in different ways than other methods have.  One of the first things I noticed was less negativity and rumination. It was like getting a nagging, negative person out of the room -- or rather, my head. I felt less heartbroken over the major losses of my life, such as having spent so much of it totally disabled.

I also noticed a big difference in my PTSD triggers. I found myself shrugging off situations that normally would put me in a very uncomfortable, perturbed state. Keep in mind, I was getting TMS applied to various points on my scalp for pain, depression and anxiety.

Since having TMS, I notice that my body is less sensitive to touch. From spa treatments to medical procedures, it does not hurt as much to be poked at or pressed on. The extra comfort TMS had given me, both mentally and physically, is a lot for someone with medical problems like mine that are so difficult to treat.

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies. 

Study Finds Spinal Cord Stimulation Has No Benefit for Back Pain

By Pat Anson, PNN Editor

A scathing new Cochrane review is raising more questions about the safety, efficacy and long-term benefits of spinal cord stimulators, medical devices that are increasingly used to treat chronic back pain.  

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence and reduce the impact of biased, poor-quality studies.

The review by Australian researchers concluded that spinal cord stimulation (SCS) works no better than a placebo for treating chronic low back pain, and provides little to no benefit in improving quality of life.

The devices are surgically placed near the spine and connected to batteries implanted under the skin, which send electrical impulses into the spine to mask pain.

“Spinal cord stimulation is invasive and has a great financial cost to people who choose surgery as a last resort to alleviate their pain. Our review found that the long-term benefits and harms are essentially unknown,” said lead author Adrian Traeger, PhD, a Research Fellow at the Institute for Musculoskeletal Health at the University of Sydney. “Our review of the clinical data suggests no sustained benefits to the surgery outweigh the costs and risks.”

Treager and his colleagues analyzed the results of 13 clinical trials of SCS devices, looking at data from almost 700 patients with low back pain. They found little to no clinical data on the long-term effectiveness of SCS because most of the studies lasted less than a month, were poorly blinded, or had selective reporting bias.

The researchers also found that side effects from SCS surgery were poorly documented, preventing them from assessing the level of risk involved. Serious adverse events include nerve damage, infection, and the devices’ electrical leads moving, all of which may lead to more surgeries.

“Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention,” they concluded. 

Findings from the Cochrane review have been submitted to Australia’s Department of Health and Aged Care, which is reviewing the effectiveness of spinal cord stimulators. The devices' long-term safety and performance are also being re-assessed by Australia's Therapeutic Goods Administration (TGA).

“Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often break down there is clearly a problem here that should be of concern to regulators,” said Chris Maher, PhD, Co-Director of Sydney Musculoskeletal Health.

Increasing Use of Stimulators

About 50,000 spinal cord stimulators are implanted annually in the U.S. and their use is growing. The devices are no longer limited to patients with back, neck and leg pain. In 2021, the FDA expanded the use of SCS to treat chronic pain from diabetic neuropathy. Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. A more recent study found that patients with the devices did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation.

Although evidence is growing that questions the safety and effectiveness of SCS, medical device companies continue to roll out new stimulators with more advanced technology. This week Nevro said it would release the first SCS system in the U.S. that uses artificial intelligence to optimize pain relief for each patient. The HFX iQ SCS system is designed for patients with diabetic neuropathy or chronic back and leg pain.

"This is an exciting time in spinal cord stimulation -- better waveforms, more conditions we can treat, and a massive treasure trove of patient data," said Usman Latif, MD, an interventional pain specialist and consultant to Nevro.

“What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, and bring the power of all that knowledge into the palm of our patient's hand -- with them 24/7, monitoring them, and offering them the best program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."

In addition to the U.S. release of HFX iQ, Nevro has asked for approval from regulators in Europe and Australia.