Back Pain Will Cost Australia Billions, but Rx Opioids Dismissed as a Remedy

By Crystal Lindell

A new study is sounding the alarm about lost worker productivity in Australia caused by chronic back pain, but an inexpensive remedy is being dismissed as “low-value or harmful.” 

Published in JAMA and led by researchers at Monash University, the study projects massive losses in productivity in Australia caused by long-term back pain. In 2024, nearly 3 million Australians had chronic back problems. That’s projected to grow to nearly 3.3 million by 2033.

The researchers estimate that back problems will result in an estimated loss of 3.4 million productivity-adjusted life-years over a 10-year period. That equates to a loss of more than $638 billion in Australian dollars in the country’s gross domestic product. That’s about $414 billion in US dollars.

That’s a lot of lost productivity and money. Just a 10% reduction in the number of workers with long-term back problems would save over $41 billion Australian dollars 

“Substantial economic gains could be achieved from reducing the prevalence and impact of the condition,” wrote lead author Sean Docking, PhD, a health economist at Monash University. “Action is needed to reduce the prevalence and burden of long-term back problems, with a focus on better-quality care and supporting people of working age to remain in the workforce and working productively.”

Indeed, there is a need to reduce the “impact of the condition.” I completely agree. However, while the authors call for interventions, they ignore an obvious tool that used to be widely available in Australia until 2018: codeine. 

That’s when Australia made codeine available by prescription only. Until then, the opioid was sold over-the-counter, and no doubt was often used to help people with back pain get out of bed, go to work, and be more productive.

While pop culture has often crafted a view that opioid medications are sleep inducing and that people who take them are lazy, the reality is that millions of people take them so that they can work and be productive. That’s especially true for mild, low-risk opioids like codeine.

The Monash researchers also point out that calling in sick and working less creates “considerable financial stress and may disproportionally impact already disadvantaged communities.”

Again, I agree. Not being able to work because of chronic pain can definitely result in a huge financial burden. And effectively treating that pain can literally make it possible for people to continue working and not rely on public assistance programs.

Unfortunately, rather than addressing this or offering practical solutions, the researchers dismiss all opioids as a “low-value” care option. Instead, they recommend “high-value” care, which basically consists of vague advice to “stay active” and get back to work as soon as possible. 

“A major way of addressing the burden of long-term back problems is to reduce the proportion of individuals who receive low-value or harmful care,” researchers said. “However, contrary to evidence-based guidelines, low-value care is prevalent. Examples of low-value care have been associated with longer absences from work. By contrast, high-value care could prevent chronicity, improve patient health outcomes, and result in productivity gains that benefit society.”

Perhaps the use of opioids is associated with “longer absences” because the pain medications are only given out when patients have severe back pain and really should stay at home.

It’s frustrating that, like many pain studies these days, the Monash researchers found a way to work in a negative view of opioids and suggest that they don’t “benefit society” or improve patient health.  

The fact that they left out how the crackdown on opioid prescribing contributes to lost productivity is also disheartening, especially when opioids are an inexpensive remedy.

When people have adequate pain relief, they can be productive. When they don’t, they can’t. Chronic pain patients understand this. Now we just need medical professionals to understand it too.

When Headlines Lie: Misleading News About Opioids and Chronic Pain

By Neen Monty

The headline in Physician’s Weekly screams alarm:

“Rising Use of Potent Opioids in Chronic Pain Management”

And then the sub heading:

“Long-term opioid use for chronic pain doubled, with potent opioids rising, underscoring the need for stronger guideline adoption”

Terrifying, right? We must do something!

But now, read the article. It’s based on a study recently published in the European Journal of Pain on the prevalence of long-term opioid therapy (LTOT) when treating patients with chronic non-cancer pain.

The Dutch study looked at opioid use over a ten-year period, from 2013 to 2022, using a large dataset drawn from primary care records in the Rotterdam region. This database covered more than half a million patients and included data from over 240 general practitioners.

The researchers focused on adults aged 18 and over who had been prescribed opioids continuously for at least three months. They tracked how common LTOT was over time, and also explored which diagnoses, co-existing conditions, and other medications were associated with it. They reported their findings using basic descriptive stats and calculated LTOT prevalence per 100 patient-years to show trends over the decade.

And what did they find?

“The prevalence of LTOT increased twofold from 0.54% (95% CI: 0.51–0.58) per 100 patient years in 2013 to 1.04% (95% CI: 1.00–1.07) in 2022. The proportion of LTOT episodes solely involving potent opioids slightly increased between 2013 and 2022”

In plain English, the prevalence of long-term opioid use by patients at the end of the study was just over 1%.

Yes, that’s right: 1%.

And the prevalence increased by just half a percentage point over a decade.

Hardly a crisis. Hardly anything to scream about.

But we can’t have that! We need a clickbait headline to demonize opioids and stop their prescribing! So, instead of reporting accurately on the very small increase in opioid prescribing, they focus on the “twofold” increase. Trying to manufacture a crisis where there is none.

It’s true, the prevalence of LTOT did double, from half a percent to one percent. And that’s what the headline highlighted, to try and make it sound like there is an opioid crisis in Europe. There is not.

This tactic is often used in presenting medical research – using relative percentages rather than the actual numbers. That is because relative percentages -- “Opioid Use Doubled!” -- sounds worse than “Opioid Use Increased by Half a Percent.”

It’s a trick that researchers and the media use all the time.

Why do this? It’s dishonest. It’s deceptive. And it destroys our trust in science. They are trying to manufacture a crisis when there is none.

Why not research and report an actual crisis? Instead of making one up?

The Physician’s Weekly headline exemplifies the worst of scientific spin: inflating tiny fractional changes and omitting context. It potentially harms patients by reinforcing the myth that opioids don’t work long term and should be withheld. That myth persists because of misleading reporting like this.

Finally! An Honest Headline

It was nice to see some accurate reporting in Scimex, an Australian online news portal that tries to help journalists cover science. Instead of the usual deceptive, sensationalist headlines, this one tells the truth:

“Pain Reprocessing Therapy (PRT) could help those with mild chronic back pain”

This was so refreshing to see! Because it’s so very, very rare.

Most reporting on PRT glosses over a critical point: It has only been studied in people with mild, non-specific back pain. An average of 4 on the zero-to-10 pain scale.

That nuance is often lost in the hype about alternative treatments like PRT, cognitive behavioral therapy, mindfulness and TENS.

You do not treat 8/10 back pain the same way you treat 4/10 back pain.

What happens when people are misled about PRT? It gets recommended to people with severe, pathological pain — often with clearly identifiable causes — and everyone acts surprised when it doesn’t work.

Let’s be clear:

• PRT is not for severe back pain

• PRT is not for pain caused by pathology

• PRT is not a cure-all

But you wouldn’t know that from most headlines about PRT, such as “New therapy aims to cure back pain without drugs, surgery” and “A New Way to Treat Back Pain.”

Then you read the small print: All the participants in PRT studies had non-specific back pain from an unknown cause. And they had mild pain.

The researchers are often complicit, cherry-picking and hyping their own data. Why? Because they need funding. Because they’re writing a book. Because professors have to "publish or perish" to keep their jobs. Because it’s easier to mislead the public than to admit a therapy has limits. And you don’t get to be a guru if your therapy only works for a minority of patients with mild pain.

This kind of spin harms people with severe chronic secondary pain. It feeds the narrative that if you're still in pain, then it’s your fault. You didn’t try hard enough. You’re catastrophizing. You need to retrain your brain.

It feeds the stigma that all chronic pain is mild and easily curable. And that anyone who says their pain is severe has psychological problems.

No. Maybe their pain is caused by pathology, like tissue damage or herniated discs. Maybe their pain is nociceptive or neuropathic.

This is why chronic pain patients must be included on every research team. Someone with real-world, high-impact chronic pain would never let this kind of misrepresentation slide. And the rest of the team wouldn’t be able to claim ignorance.

We need more honesty and integrity in research and the media. We need headlines that reflect the actual findings. We need conclusions that match the data, not some predetermined narrative. Right now, most media coverage doesn’t even try.

Read the study, then read the headline. They rarely match. That’s how we ended up with a generation of healthcare providers who think opioids are bad, all chronic pain is primary pain, and that PRT is some miracle therapy.

It’s not. PRT may be helpful to people who are depressed or have anxiety, but should not be a first-line treatment for everyone. It’s only been tested in people with mild back pain for which there is no known physical cause. It has not been shown to work for people with severe pain or structural pathology.

But the researchers usually gloss over that. And the headlines and conclusions rarely reflect those facts or spell out who PRT is for and who it is not for.

Because here’s the truth: Pain Reprocessing Therapy is not a treatment for chronic pain. It’s a treatment for anxiety and depression.

That’s the real headline.

Neen Monty is a patient advocate in Australia who lives with rheumatoid arthritis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a progressive neurological disease that attacks the nerves.

Neen is dedicated to challenging misinformation and promoting access to safe, effective pain relief. She has created a website for Pain Patient Advocacy Australia to show that prescription opioids can be safe and effective, even when taken long term. You can subscribe to Neen’s free newsletter on Substack, “Arthritic Chick on Chronic Pain.”

Can AI Videos Replace In-Person Physical Therapy?

By Crystal Lindell

A UK-based technology company claims their Artificial Intelligence (AI) videos are good enough to replace in-person physical therapy for some back pain patients. 

Like the United States, the waiting time in the UK to see a medical specialist can be daunting. According to the UK’s National Health Service (NHS), the average wait time after a referral for simple back or spine pain is more than 18 weeks. Nearly 350,000 people in England were on waiting lists for treatment for musculoskeletal problems last year. 

But in a pilot study of over 2,500 NHS patients who used a physiotherapy (physical therapy) app operated by Flok Health, the waiting times were cut in half. 98% of referred patients continued watching the AI powered videos, while only 2% required or requested a transfer to traditional to face-to-face care with a therapist.

The app works by showing patients pre-recorded videos of actual human instructors, but then tailors the video clip order based on how AI interprets responses from the patient. 

“Each appointment is like a 30 minute video call, except our side of the call is created by our AI engine in real-time, just for you,” Flok Health explains on its website. “You can answer questions and your digital physio will respond to you live, in a continuously generated personal video stream.”

Patients are also prescribed a set of exercises for the coming week before the next appointment. Flok Health says the exercises are specifically selected based on “a detailed analysis of symptoms and movement patterns.” The app also guides patients through practicing their exercises between appointments, and helps them see their progress and stay on track.

Patients also have access to human physiotherapists and doctors. The company said they monitor patient recovery remotely and can arrange to speak to a patient if they have questions. 

The BBC's Scott Nover tried the app back in March and wrote about his experience with an AI generated physical therapist named “Kirsty.” He found her recommendations lacking, with his main complaint being that Kirsty wasn’t able to correct his form in real time like a live therapist would.

“The big difference here is that Kirsty can't see me. Her pre-recorded videos don't watch my movements and stretches. They rely on me following her instructions correctly and reporting if something is amiss,” Nover wrote.

“My back felt better after my sessions with Flok, but the app likely isn't for me. I'm clumsy and uncoordinated and need someone watching my form at all times – if not, I'm likely to hurt myself further.”

However, I could see a near-future scenario where AI is able to analyze patient form in real-time with technology that’s similar to that used in gaming counsels like XBox Kinect. 

Nover also pointed to a 2024 study for a similar AI-powered back pain treatment called selfBACK that found patients were unlikely to use it. Nearly one-third of patients never accessed the app, and another third rarely used it. 

It’s definitely easier to blow off an app than it is to blow-off an in-person physical therapy appointment with an actual human being, so those results make sense. 

As a patient, I’ve had both in-person physical therapy referrals given to me sometimes, and links to relevant videos with accompanying handouts provided to me at other times. 

To be frank, this Flok Health app sounds a lot like that latter. And I will confess that I was a lot less likely to follow a physical therapy treatment plan when it didn’t involve an actual physical therapist.

At the same time, at least in the United States, physical therapy can be very expensive, especially when there’s a high co-pay for each session. So having less expensive treatment options is a good thing. Although it’s unclear when Flock might be widely available to U.S. patients.

I’m skeptical that AI will be fully replacing physical therapists any time soon, but it sounds like tech companies are hoping they can make a massive dent in their client base and waiting times..

Flexible Implant Could Be Alternative to Spinal Cord Stimulators

By Pat Anson

Spinal cord stimulators have long been fraught with problems. First developed in the 1960’s, the devices are surgically implanted near the spine to deliver mild electric impulses that block pain signals from traveling to the brain.

Although their design and technology have improved over the years, making them smaller, rechargeable and programmable, spinal cord stimulators (SCSs) still have high failure rates and poor safety records. Recent studies have also questioned their effectiveness in treating back pain.

Researchers at the University of Southern California have developed an alternative: a small, flexible, wireless, and battery-free implant that could overcome some of the limitations of SCSs.

NATURE ELECTRONICS

The experimental device, recently introduced in a paper published in Nature Electronics, is powered by a wearable ultrasound transmitter and uses machine learning algorithms to customize treatment for each patient. The implant is designed to bend and twist, unlike traditional stimulators that tend to be bulky and are hard-wired to batteries.

“Implantable percutaneous electrical stimulators… are expensive, can cause damage during surgery and often rely on a battery power supply that must be periodically replaced. Here we report an integrated, flexible ultrasound-induced wireless implantable stimulator combined with a pain detection and management system for personalized chronic pain management," wrote a team of researchers at USC’s Alfred E. Mann Department of Biomedical Engineering.

The researchers tested the wireless stimulator in laboratory rodents experiencing different levels of pain. They found the device accurately predicted the levels of stress experienced by the animals and adapted the electrical stimulation it delivered, easing most of their pain.

“We classify pain stimuli from brain recordings by developing a machine learning model and program the acoustic energy from the ultrasound transmitter and, therefore, the intensity of electrical stimulation," researchers said. "The implant can generate targeted, self-adaptive and quantitative electrical stimulations to the spinal cord according to the classified pain levels for chronic pain management in free-moving animal models."

The research team is planning further tests on other lab animals, with the goal of eventually testing the device in clinical trials on humans.

About 50,000 traditional spinal cord stimulators are implanted every year in the U.S., where they are promoted as alternatives to opioids and other pain treatments. However, a 2022 study found that SCSs do not reduce patient use of opioids, epidurals, steroid injections or radiofrequency ablation. About a fifth of patients experienced complications so severe the devices had to be removed or revised.

The Two Most Common Causes of Adhesive Arachnoiditis

By Dr. Forest Tennant

Adhesive arachnoiditis (AA) doesn’t just happen out-of-the-blue or overnight. It is the tragic end result of sequential pathologic damage, over time, to multiple spinal tissues.

AA may develop from a direct spinal injury or from an inflammatory, autoimmune disease that originates outside the spine.  The discovery that inflammatory-autoimmune diseases can originate outside the spine and spread into spinal tissue is a new medical concept.

Here are the two common pathologies that can cause AA, and the early symptoms that precede AA itself:

Pathology #1: Spinal Trauma

The first pathologic journey is accidental spine trauma or a medical procedure such as an epidural injection that damages the spinal canal cover, which consists of an outer layer (dura) and an inner layer (arachnoid).

Direct spinal injuries may occur to persons in good health.  Examples are auto accidents or electrocution in an industrial accident. The arachnoid layer becomes inflamed after trauma, just like a finger that has been hit with a hammer. The inflammation may progress and then spread.

Eventually, the inflammation will contact cauda equina nerve roots and spread into them. After a time ranging from weeks to months, the inflammatory adhesions “glue” cauda equina nerve roots to the arachnoid, forming the disease called adhesive arachnoiditis.

Pathology #2: Degenerative Discs

Spinal discs degenerate when they become inflamed, due to a pathologic generator such as an infection, autoimmunity or trauma.

Persons who have a genetic connective tissue disease like Ehlers-Danlos, a spine anatomic abnormality, or an autoimmune disease are at high risk to develop degenerative disc disease. Once inflammation sets in, the disc softens, shrinks and slips out of its space, pressing against the spinal canal cover (dura and arachnoid layers).

The inflammation in the disc may spread to the arachnoid membrane and cauda equina nerve roots. As stated in Pathology #1, when inflammation produces sticky adhesions in the cauda equina nerve roots and arachnoid, they may glue together forming AA.

Early Symptoms

If the arachnoid becomes inflamed after trauma, epidural injection, spinal puncture or surgical procedure, there will be headaches, localized back pain, feverishness and dysphoria (a state of unease, depression and fatigue). This usually starts 7 to 10 days after the procedure or trauma.

When the cauda equina also becomes inflamed, the first early symptoms are shooting pains into the buttocks and legs, burning feet, and the tingling sensation of water or insects on the buttocks or legs.

Prevention of AA may be possible in these circumstances by use of one or more anti-inflammatory drugs that are effective inside the spinal canal. You can learn more about the symptoms and treatments for AA on our website.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.

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

How Chronic Pain Impacts Romantic Relationships

By Crystal Lindell

The more you love someone with chronic pain, the more likely it is that their pain will cause you emotional distress. 

That’s according to new research published in the Journal of Health Psychology, which looks at the ways middle-aged romantic partnerships are impacted when one person has chronic pain. 

The researchers collected twice-daily surveys over the span of 30 days from 147 couples who were at least 50 years of age and had one partner who suffered from chronic back pain. 

Using the couples' answers to questions about distress and relationship closeness, as well as reports of pain severity from the pain-affected partner, they examined how emotional, behavioral and cognitive closeness affected the quality of couples’ daily interactions.

On the positive side, researchers found that emotional closeness between couples dealing with chronic pain led to more marital satisfaction on days when the couple felt close. 

However, on the other side of things, the closer the couple felt emotionally on any given day, the more likely it was that the non-pain partner experienced more distress. The non-pain partner apparently feels empathy for the pained partner, which results in them feeling stressed. 

As anyone who’s ever been in love knows, empathy is the required price. When your partner is sad, you will also tend to be sad on their behalf. 

This is not inherently a bad thing. Feeling empathy for your partner when they are dealing with pain makes it more likely that you’ll work harder to ease their pain, by doing things like advocating for them in healthcare settings and allowing them to rest while you do the household chores. 

The researchers framed this as something to avoid though, which I guess makes sense if it’s happening excessively.

“Couples have to find a balance that is ideal for them in managing closeness versus independence — this is true for all couples, not just those dealing with the impacts of chronic pain. But for those dealing with chronic pain, we can help them learn how to balance the benefits of closeness with minimizing shared distress stemming from a chronic condition,” lead researcher Lynn Martire, PhD, a professor of human development and family studies at Penn State’s Center for Healthy Aging, said in a press release.: 

The findings suggest that methods could be developed to help couples find the right balance in closeness, which would protect them from causing more pain and distress for each other. Martire and her colleagues plan further studies on the roles of behavioral and cognitive closeness.

“I’m excited to dive deeper into the other research questions we can examine from this data set,” Martire said. “We gathered data using different measures of relationship closeness, how they differ between patients and partners and how relationship closeness changes over time. We are poised to learn a great deal about the impact of pain on couples.”

Prior studies show that closeness is associated with many positive and beneficial relationships, including higher levels of commitment and satisfaction, and a lower risk of the relationship ending. 

However, researchers also say their findings suggest that too much closeness may transfer negative emotions and physical symptoms between partners.

“These findings illustrate a complex interplay between closeness and personal well-being in couples managing chronic illness and suggest the need for interventions that target both the benefits and potential costs of closeness,” they concluded. 

Yes, indeed, there are “benefits and potential costs” in any close relationship. It’s a contradiction that countless poets have spent centuries trying to navigate. 

Love comes at a price, but most of the time, the price is worth it. 

New Guideline Recommends Against Injections for Chronic Back Pain

By Pat Anson

An international panel of experts has released a new guideline strongly recommending against injections for chronic back pain, saying the procedures provide little or no pain relief and there is little evidence to support their use.

The guideline, published in The BMJ, covers 13 commonly used interventional procedures, including epidural injections, joint injections, intramuscular injections, nerve blocks, and radiofrequency ablation. The injections usually involve steroids, a local anesthetic, or a combination of the two.

The expert panel conducted an analysis of dozens of clinical trials and studies, and found “no high certainty evidence” of pain relief for any of the procedures. There was only low or moderate evidence that injections work better than a placebo or sham procedure.

Injections for chronic axial or radicular spine pain have become increasingly common in recent years, and are often touted as safer alternatives to opioid medication.

However, the injections also come with risks, including infections, prolonged pain and stiffness, accidental punctures of the spinal membrane, and rare but “catastrophic complications” such as paralysis. The risks are magnified because many of the procedures are performed multiple times on the same patient.

“The panel had high certainty that undergoing interventional procedures for chronic spine pain was associated with important burden (such as travel, discomfort, productivity loss), which would be recurring as these interventions are typically repeated on a regular basis, and that some patients would bear substantial out-of-pocket costs,” wrote lead author Jason Busse, DC, a professor of anesthesia at McMaster University in Ontario, Canada.

“The panel concluded that all or almost all informed patients would choose to avoid interventional procedures for axial or radicular chronic spine pain because all low and moderate certainty evidence suggests little to no benefit on pain relief compared with sham procedures, and these procedures are burdensome and may result in adverse events.”

Chronic back pain is the leading cause of disability worldwide. Over 72 million U.S. adults suffer from chronic low back pain, according to a 2022 Harris Poll. About a third of those surveyed rated their pain as severe and nearly half said they experienced chronic back pain for at least five years. The vast majority (80%) rated opioids as the most effective treatment.

Pain Management Needs ‘Major Rethink’

In an editorial also published in The BMJ, Jane Ballantyne, MD, an anesthesiologist and retired professor at the University of Washington, said the new guideline raises questions about whether interventional procedures should even be used to treat chronic back pain. 

“The question this recommendation raises is whether it is reasonable to continue to offer these procedures to people with chronic back pain. Chronic back pain is highly prevalent, a great deal of money is spent on the injections, and a lot of patient hopes and expectations are vested in this type of treatment,” wrote Ballantyne. 

“One might ask how the situation arose whereby we spend so much of our healthcare capital on a treatment for a common condition that compromises the lives of so many people but seemingly does not work.”

For Ballantyne to ask that is more than a little ironic. She is a longtime anti-opioid activist, a former president of Physicians for Responsible Opioid Prescribing (PROP), and was a key advisor to the CDC when it drafted guidelines that strongly recommend against opioid therapy.

With opioids increasingly difficult to obtain, many patients with chronic back pain have no alternative but to have interventional procedures, spinal surgeries, or implanted medical devices such as pain pumps and spinal cord stimulators.

Some doctors and pain clinics welcome the opportunity to bill for those expensive procedures, and refuse to give opioids to patients unless they agree to become “human pin cushions.”

“One might ask how the situation arose whereby we spend so much of our healthcare capital on a treatment for a common condition that compromises the lives of so many people but seemingly does not work.”

— Jane Ballantyne, MD

One might ask Ballantyne what patients with chronic back pain are supposed to do without injections or opioids. Her editorial provides no answers.

“This (new guideline) will not be the last word on spine injections for chronic back pain, but it adds to a growing sense that chronic pain management needs a major rethink,” Ballantyne wrote.

Earlier this month, the American Academy of Neurology released a new evidence review that found epidural steroid injections have limited efficacy, and only modestly reduce chronic back pain for some patients with radiculopathy or spinal stenosis.

Pain Clinics Used Patients as ‘Human Pin Cushions’ for Injections

By Brett Kelman, KFF Health News

Each month, Michelle Shaw went to a pain clinic to get the shots that made her back feel worse — so she could get the pills that made her back feel better.

Shaw, 56, who has been dependent on opioid painkillers since she injured her back in a fall a decade ago, said in both an interview with KFF Health News and in sworn courtroom testimony that the Tennessee clinic would write the prescriptions only if she first agreed to receive three or four "very painful" injections of another medicine along her spine.

The clinic claimed the injections were steroids that would relieve her pain, Shaw said, but with each shot her agony would grow. Shaw said she eventually tried to decline the shots, then the clinic issued an ultimatum: Take the injections or get her painkillers somewhere else.

"I had nowhere else to go at the time," Shaw testified, according to a federal court transcript. "I was stuck."

Shaw was among thousands of patients of Pain MD, a multistate pain management company that was once among the nation's most prolific users of what it referred to as "tendon origin injections," which normally inject a single dose of steroids to relieve stiff or painful joints.

As many doctors were scaling back their use of prescription painkillers due to the opioid crisis, Pain MD paired opioids with monthly injections into patients' backs, claiming the shots could ease pain and potentially lessen reliance on painkillers, according to federal court documents.

Now, years later, Pain MD's injections have been proved in court to be part of a decade-long fraud scheme that made millions by capitalizing on patients' dependence on opioids.

The Department of Justice has successfully argued at trial that Pain MD's "unnecessary and expensive injections" were largely ineffective because they targeted the wrong body part, contained short-lived numbing medications but no steroids, and appeared to be based on test shots given to cadavers — people who felt neither pain nor relief because they were dead.

Four Pain MD employees have pleaded guilty or been convicted of health care fraud, including company president Michael Kestner, who was found guilty of 13 felonies at an October trial in Nashville, Tennessee. According to a transcript from Kestner's trial that became public in December, witnesses testified that the company documented giving patients about 700,000 total injections over about eight years and said some patients got as many as 24 shots at once.

"The defendant, Michael Kestner, found out about an injection that could be billed a lot and paid well," said federal prosecutor James V. Hayes as the trial began, according to the transcript. "And they turned some patients into human pin cushions."

The Department of Justice declined to comment for this article. Kestner's attorneys either declined to comment or did not respond to requests for an interview. At trial, Kestner's attorneys argued that he was a well-intentioned businessman who wanted to run pain clinics that offered more than just pills. He is scheduled to be sentenced on April 21 in a federal court in Nashville.

According to the transcript of Kestner's trial, Shaw and three other former patients testified that Pain MD's injections did not ease their pain and sometimes made it worse. The patients said they tolerated the shots only so Pain MD wouldn't cut off their prescriptions, without which they might have spiraled into withdrawal.

"They told me that if I didn't take the shots — because I said they didn't help — I would not get my medication," testified Patricia McNeil, a former patient in Tennessee, according to the trial transcript. "I took the shots to get my medication."

In her interview with KFF Health News, Shaw said that often she would arrive at the Pain MD clinic walking with a cane but would leave in a wheelchair because the injections left her in too much pain to walk.

"That was the pain clinic that was supposed to be helping me," Shaw said in her interview. "I would come home crying. It just felt like they were using me."

‘Medically Unnecessary’ Injections

Pain MD, which sometimes operated under the name Mid-South Pain Management, ran as many as 20 clinics in Tennessee, Virginia and North Carolina throughout much of the 2010s. Some clinics averaged more than 12 injections per patient each month, and at least two patients each received more than 500 shots in total, according to federal court documents.

All those injections added up. According to Medicare data filed in federal court, Pain MD and Mid-South Pain Management billed Medicare for more than 290,000 "tendon origin injections" from January 2010 to May 2018, which is about seven times that of any other Medicare biller in the U.S. over the same period. 

Tens of thousands of additional injections were billed to Medicaid and Tricare during those same years, according to federal court documents. Pain MD billed these government programs for about $111 per injection and collected more than $5 million from the government for the shots, according to the court documents.

More injections were billed to private insurance too. Christy Wallace, an audit manager for BlueCross BlueShield of Tennessee, testified that Pain MD billed the insurance company about $40 million for more than 380,000 injections from January 2010 to March 2013. BlueCross paid out about $7 million before it cut off Pain MD, Wallace said.

These kinds of enormous billing allegations are not uncommon in health care fraud cases, in which fraudsters sometimes find a legitimate treatment that insurance will pay for and then overuse it to the point of absurdity, said Don Cochran, a former U.S. attorney for the Middle District of Tennessee.

Tennessee alone has seen fraud allegations for unnecessary billing of urine testing, skin creams and other injections in just the past decade. Federal authorities have also investigated an alleged fraud scheme involving a Tennessee company and hundreds of thousands of catheters billed to Medicare, according to The Washington Post, citing anonymous sources.

Cochran said the Pain MD case felt especially "nefarious" because it used opioids to make patients play along.

"A scheme where you get Medicare or Medicaid money to provide a medically unnecessary treatment is always going to be out there," Cochran said. "The opioid piece just gives you a universe of compliant people who are not going to question what you are doing."

"It was only opioids that made those folks come back," he said.

The allegations against Pain MD became public in 2018 when Cochran and the Department of Justice filed a civil lawsuit against the company, Kestner, and several associated clinics, alleging that Pain MD defrauded taxpayers and government insurance programs by billing for "tendon origin injections" that were "not actually injections into tendons at all."

Kestner, Pain MD and several associated clinics have each denied all allegations in that lawsuit, which is ongoing.

Scott Kreiner, an expert on spine care and pain medicine who testified at Kestner's criminal trial, said that true tendon origin injections (or TOIs) typically are used to treat inflamed joints, like the condition known as "tennis elbow," by injecting steroids or platelet-rich plasma into a tendon. Kreiner said most patients need only one shot at a time, according to the transcript.

But Pain MD made repeated injections into patients' backs that contained only lidocaine or Marcaine, which are anesthetic medications that cause numbness for mere hours, Kreiner testified.

Pain MD also used needles that were often too short to reach back tendons, Kreiner said, and there was no imaging technology used to aim the needle anyway. Kreiner said he didn't find any injections in Pain MD's records that appeared medically necessary, and even if they had been, no one could need so many.

"I simply cannot fathom a scenario where the sheer quantity of TOIs that I observed in the patient records would ever be medically necessary," Kreiner said, according to the trial transcript. "This is not even a close call."

Jonathan White, a physician assistant who administered injections at Pain MD and trained other employees to do so, then later testified against Kestner as part of a plea deal, said at trial that he believed Pain MD's injection technique was based on a "cadaveric investigation."

According to the trial transcript, White said that while working at Pain MD he realized he could find no medical research that supported performing tendon origin injections on patients' backs instead of their joints.

When he asked if Pain MD had any such research, White said, an employee responded with a two-paragraph letter from a Tennessee anatomy professor — not a medical doctor — that said it was possible to reach the region of back tendons in a cadaver by injecting "within two fingerbreadths" of the spine. This process was "exactly the procedure" that was taught at Pain MD, White said.

During his own testimony, Kreiner said it was "potentially dangerous" to inject a patient as described in the letter, which should not have been used to justify medical care.

"This was done on a dead person," Kreiner said, according to the trial transcript. "So the letter says nothing about how effective the treatment is."

Patient Treated ‘Like a Dartboard’

Pain MD collapsed into bankruptcy in 2019, leaving some patients unable to get new prescriptions because their medical records were stuck in locked storage units, according to federal court records.

At the time, Pain MD defended the injections and its practice of discharging patients who declined the shots. When a former patient publicly accused the company of treating his back "like a dartboard," Pain MD filed a defamation lawsuit, then dropped the suit about a month later.

"These are interventional clinics, so that's what they offer," Jay Bowen, a then-attorney for Pain MD, told The Tennessean newspaper in 2019. "If you don't want to consider acupuncture, don't go to an acupuncture clinic. If you don't want to buy shoes, don't go to a shoe store."

Kestner's trial told another story. According to the trial transcript, eight former Pain MD medical providers testified that the driving force behind Pain MD's injections was Kestner himself, who is not a medical professional and yet regularly pressured employees to give more shots.

One nurse practitioner testified that she received emails "every single workday" pushing for more injections. Others said Kestner openly ranked employees by their injection rates, and implied that those who ranked low might be fired.

"He told me that if I had to feed my family based on my productivity, that they would starve," testified Amanda Fryer, a nurse practitioner who was not charged with any crime.

Brian Richey, a former Pain MD nurse practitioner who at times led the company's injection rankings, and has since taken a plea deal that required him to testify in court, said at the trial that he "performed so many injections" that his hand became chronically inflamed and required surgery.

"'Over injecting killed my hand,'" Richey said on the witness stand, reading a text message he sent to another Pain MD employee in 2017, according to the trial transcript. "'I was in so much pain Injecting people that didn’t want it but took it to stay a patient.'"

"Why would they want to stay there?" a prosecutor asked.

"To keep getting their narcotics," Richey responded, according to the trial transcript.

Throughout the trial, defense attorney Peter Strianse argued that Pain MD's focus on injections was a result of Kestner's "obsession" with ensuring that the company "would never be called a pill mill."

Strianse said that Kestner "stayed up at night worrying" about patients coming to clinics only to get opioid prescriptions, so he pushed his employees to administer injections, too.

"Employers motivating employees is not a crime," Strianse said at closing arguments, according to the court transcript. "We get pushed every day to perform. It's not fraud; it's a fact of life."

Prosecutors insisted that this defense rang hollow. During the trial, former employees had testified that most patients' opioid dosages remained steady or increased while at Pain MD, and that the clinics did not taper off the painkillers no matter how many injections were given.

"Giving them injections does not fix the pill mill problem," federal prosecutor Katherine Payerle said during closing arguments, according to the trial transcript. "The way to fix being a pill mill is to stop giving the drugs or taper the drugs."

KFF Health News is a national newsroom that produces in-depth journalism about health issues. 

Why Life With Chronic Pain Makes Every New Ache Extra Terrifying

By Crystal Lindell

Late Sunday night, while putting freshly cleaned sheets onto my bed, I twisted a little weird and threw out my back.

By Monday morning, the pain was so debilitating that I was sobbing as my fiancé tried to help me out of our bed. But beyond dealing with the immediate physical pain, I was also terrified of the future.

As a chronic pain patient, every time I get any new illness or affliction I worry that it will become what the rib pain I woke up with in 2013 became: Permanent. 

When you develop chronic health issues of any sort, you lose one of the healthy population’s greatest luxuries: The ability to assume that you’ll eventually get better. 

Thankfully, I seem to be recovering from this flare up of back pain. Three days after the initial onset, I’m able to lift myself out of bed, and even do some light cooking in the kitchen. 

This is the first time I’ve ever experienced any type of severe back pain like this though, and I had been very stressed that my back would never recover.

This isn’t the first time I’ve faced this fear. 

When I had a bad case of COVID in 2022, I spent the first few nights awake with the most severe cold-related muscle aches I’d ever experienced.

In my fever state, I frantically Googled to see if this was a symptom that could become permanent. I was petrified that my body was just broken like this forever. Thankfully it wasn’t, but I know all too well that there’s no guarantee of recovery when it comes to the human body.

It’s not just my health I worry about either. 

Anytime a loved one tells me about a chest cold, some new joint pain, or any type of new health issue, I panic that their body will never recover. Or worse, what if it kills them?

This fear has only been made worse since 2020, when COVID, which first presents as cold symptoms, started spreading. In the years since it has killed multiple people I knew. 

Now anytime anyone I know develops so much as a sore throat, I worry that they’re going to die.

I keep this to myself because there’s nothing to be gained by spreading my worry to them, but I worry nonetheless. I know firsthand how fragile our bodies are, how delicate our health truly is. I am all too aware of the fact that any of us can lose it at any time. 

As I've been enduring the new back pain all week, cursing myself for taking my ability to bend over for granted, I’ve thought a lot about my late-father, who died from COVID in 2022. 

I have vivid memories of him throwing his back multiple times throughout my childhood. Now that it has happened to me, I’ve realized that I didn’t spend nearly enough time asking him how he coped with it, and then seemingly got past it. 

My dad’s back was so bad that he was walking with a cane at age 35, when my younger brother was born in 1989. But the cane was gone within a few years and I don’t remember him needing it again after that. 

Talking with my brother this week, he told me our dad blamed his back pain on driving a truck for a living, a profession he eventually gave up so he could pursue computer programming. So, I assume it was the career change that alleviated his back pain. But now that he’s dead, I’ll never really know for sure how he healed his back, or if he even really did.

My late-grandfather on my mother’s side also spent decades of his life battling seemingly untreatable back pain. He passed away when I was a toddler, but stories about his back pain continued long past his death. 

Now, as an adult, I suspect he was one of the links in the genetic Ehlers-Danlos chain that we now know runs along my mom’s side of the family. We both battled the same condition, but he’ll never know that.

Pain is always bad, but as our bodies age in the same ways our parents, and their parents before them have, it does have one small, silver lining: It can help us connect to our ancestors in new ways, helping us more fully grasp the lives they lived before us. 

After battling this back pain flare up this week, I have a new appreciation for how much pain my dad and my grandfather must have endured due to their back problems, and a more fully developed sense of empathy for their troubles. 

So while I will continue to worry that every new health issue will become permanent, including my new back pain, I can take small comfort in knowing that even if that’s the case, enduring it just makes me part of a long line of my ancestors who’ve endured the same before me. 

Human beings suffer, but when we suffer together, it does tend to alleviate our sorrows ever so slightly. 

You Are a Medical Commodity

By Dr. David Hanscom 

The shocking murder of a health insurance executive and the glorification – by some – of Luigi Mangione, the alleged killer, has underscored how many Americans feel about the U.S. healthcare system.

Medicine has become big business and you, the patient, are a hot commodity. You and your health problems are the main source of revenue for many companies needing to report big profits to their shareholders. In this era of so-called health reform, it’s essential to understand what this means to you – and the news is not good.

As a spine surgeon, I enjoy caring for patients and performing surgeries when needed, and do my best to help people feel better and function well. Unfortunately, most people getting spine surgery today not only won’t be helped, they’ll suffer more as a result of complications from surgeries they shouldn’t have.

For example, let’s look at spinal fusion for low back pain. There is clear research showing that only about 25% of patients significantly benefit from a spine fusion for lower back pain. Another report from Washington State, where I practiced, showed that just 15% of people who had a spinal fusion returned to work one year after their operation.

Physicians today are trained to use evidence-based data to make treatment decisions – and yet, when it comes to low back pain, the data is routinely ignored. A 2009 study showed that physicians eschew established clinical guidelines for best practices in treating back pain.

3 Patient Stories: George, Teresa and Tom

George, a middle-aged businessman, had lower back pain. The first spinal fusion he had didn’t help, so he had another. As a result of complications from that second (unnecessary) surgery, he lost bowel and bladder function, and has to walk with crutches.

Teresa was struck in the back by a swinging steel beam while at work. It was a significant blow, but she only had a bruise, no fractures.  Her discomfort was treated with 15 sets of injections that included facet blocks, epidural cortisone injections, and dye into most of her discs.

She also underwent a spinal fusion from her neck down to her pelvis – an operation that made it impossible for her to stand upright, as she was fused in a flexed-forward position. I was able to help her stand up straight again after a 10-hour procedure that involved cutting her spine in two to re-straighten her back.

Had Teresa only gotten some work on her back muscles after the workplace injury, she could have gone back to everyday life without surgery.

Tom had a narrowing of his lumbar spinal canal caused by spinal stenosis, which caused weakness in his legs. The stenosis should have been treated with a simple, three-level laminectomy (simple removal of bone), as his spine was stable. Instead, he had surgery to fuse his spine at eight levels from his 10th thoracic vertebra to the pelvis. A fusion is only indicated for an unstable spine and is a much bigger operation.

After the fusion, Tom suffered a series of infections and fractures, requiring 15 additional operations in 30 months. He is now solidly fused at 24 levels from the base of his skull to his pelvis. He did not do well.

I could share dozens of stories like these, all with a common theme. Though they were experiencing back and leg pain, not a single one required fusion surgery. Fusions are necessary and helpful only for unstable or deformed spines, and they do not relieve back pain. The more significant number of levels fused during surgery requires more extended operations, which have a higher chance of complications.

All three of the patients I described above could have been helped with a structured spine care program to implement known effective treatments to decrease their pain and improve the odds of a successful surgery.

Instead, they were subjected to unnecessary risks and unspeakable misery. Spread out over the hundreds of thousands of other patients who could tell similar stories, the costs to society in dollars and human suffering are enormous.

Why Is This Happening?  

There are several reasons, some concerning how doctors are trained, but money is a significant factor. Spinal fusion is a lucrative procedure for hospitals.  Hospitals now employ an increasing number of physicians and many use their electronic medical records to track the number of diagnostic tests that their doctors order and the surgical procedures they perform. Doctors are rewarded financially with bonuses for doing as many surgeries as possible, but they get negative ratings for not doing enough to contribute to the institution's profitability.

That’s bad enough, but even worse, these highly profitable procedures have been well-documented as not working. Effective treatments are often (usually) not covered by insurance. Instead of solving and preventing disability, the business of medicine is creating it. The total cost of chronic disease in the U.S. is approaching $4 trillion a year. Yet nothing is being done to solve it.

The Hippocratic Oath swears us doctors to first to do no harm. That also means doing the right thing for our patients, regardless of the situation. It is often said that the financial incentives need to change to create a healthier medical system. The Oath does not say to treat patients with the best standard of care only if they can pay for it.

One place change has to occur is with each physician refusing to be intimidated by hospital administrators and by demanding more time to talk to their patients.

This is a complicated state of affairs, and I am not blaming any group for causing it. I am continually impressed by how committed physicians are to doing the right thing for patients. But in this practice-for-profit climate, they need to be allowed more time or be given the resources to do so.

Only about 10% of spine surgeons implement psychological screening prior to surgery that will optimize a patient’s chances of a successful outcome. Many surgeons don’t feel it is their responsibility. Really? Are we going back to the days when barbers were the surgeons? Are we only technicians?

Hospital systems are problematic because administrative costs have risen 3,000% over the last 10 years, while physician salaries have grown by 15%. The increased “productivity” goes directly into management’s pockets.

BTW, 65% of personal bankruptcies are caused by medical bills. Could this be a factor in creating our homelessness epidemic?

Profits Over Safety

The core problem lies with the healthcare-for-profit model and the scale at which it is being practiced. It is focused on making money off of illness, rather than encouraging wellness. Businesses must operate profitably, but at whose expense? Is there any shareholder willing to trade their health for the betterment of the bottom line? Why should you be the one to be the fuel for this machine?

We can’t afford to continue down this road. Medical consumers – that’s you, me, and our husbands, wives, mothers, fathers, sisters, brothers, sons, and daughters -- are the core revenue source. We must become better, more educated and more vocal consumers of healthcare, and we must refuse to be treated like medical commodities.

This effort needs to begin NOW and with one person at a time. You deserve much better than this.

David Hanscom, MD, is an orthopedic spine surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

David is the author of ”Back in Control: A Spine Surgeon's Roadmap Out of Chronic Pain,” one of the books on back pain that was read by Luigi Mangione.

CrossFit Training May Reduce Need for Pain Medication

By Athalie Redwood-Brown and Jen Wilson

Though CrossFit is often seen as a sport for the super fit, that shouldn’t put you off from trying it. CrossFit is designed to be accessible to everyone, with scalable workouts suited for all ages and abilities, embodying its principle that the needs of elite athletes and beginners differ only by intensity, not kind. By combining strength and aerobic exercise, CrossFit can be an effective way of improving functional fitness, muscle strength and cardiovascular health.

But if that’s not enough to convince you, our latest study suggests CrossFit’s benefits for physical health may even potentially reduce the need to use prescription drugs in people living with long-term conditions. This may offer an alternative to traditional medication-based treatment for a range of health conditions, as well as potentially easing the demand on healthcare services.

To conduct our study, we recruited 1,211 people from the UK who did CrossFit. Participants ranged in age from 19-67 – though the majority of participants were in either the 30-39 (38%) or 40-49 (26%) groups. Participants were asked about their health, what prescription drugs they took and any changes in their prescriptions since starting CrossFit.

Of the 1,211 participants, 280 said they took at least one prescription drug to manage a health condition prior to starting CrossFit. Some of the most common health conditions in question included anxiety and depression, asthma, high blood pressure, type 2 diabetes and chronic pain.

Fewer Meds and Doctor Visits

We found that 54% of participants who’d been taking a prescription drug before starting CrossFit said they decreased their dosage after starting. Among this group of 151 people, 69 reported stopping their medication entirely, while the remaining 82 said they had cut their prescription dosage by more than half. These improvements happened primarily within the first six months of training.

Younger participants, specifically those aged 20 to 29, were more likely to reduce their medication. In this group, 43% reported cutting their prescription dosage by more than half, and 27% stopped needing to use a prescription drug altogether (compared to 29% and 25% respectively across all age groups).

We also found that 40% of all participants said they required fewer visits to the doctor after starting CrossFit.

For people with long-term health issues such as chronic pain, CrossFit helped many manage their symptoms. Our study found that of those participants who reported taking painkillers prior to starting CrossFit, particularly to manage arthritis or back pain, over half reduced their medication.

Some even postponed or cancelled surgeries for joint or muscular issues due to the strength and fitness they had gained after starting CrossFit. Of the 71 people who reported cancelling or postponing surgeries, 55% said it was because their symptoms improved, while 31% actually reported they no longer needed surgery at all.

While our study can’t directly prove that CrossFit caused these changes, the effects that CrossFit has on so many aspects of health may help explain why regular exercisers saw a decrease in their prescription drug use.

First, CrossFit is of course beneficial for physical fitness. Improvements in areas such as cardiovascular fitness and metabolic health may help in managing chronic conditions such as type 2 diabetes and high blood pressure.

Second, because CrossFit is often done as a group in a gym setting, it fosters a sense of community, team spirit and support. This sense of community may enhance mental health and wellbeing. Exercise also releases endorphins – chemicals in the brain that boost happiness and decrease pain. These two factors may help explain why a number of the study’s participants reported using fewer antidepressants after starting CrossFit.

Third, the fact that CrossFit’s combination of strength, aerobic and functional exercises helps enhance muscle strength and endurance can alleviate pressure on joints and reducing pain. The high-intensity nature of CrossFit also promotes the release of endorphins which can alleviate discomfort and enhance physical resilience, leaving participants feeling more empowered and uplifted.

As well, CrossFit emphasises movement patterns and mobility, which can help improve flexibility and reduce stiffness. All of these factors might help explain why some of the participants who’d suffered with chronic pain prior to starting CrossFit relied less on painkillers after six months of training

Nonetheless, this study has some limitations to note. The data relies on self-reported information, which can lead to biased results as participants may not accurately remember their prescription use or be influenced by their feelings about CrossFit.

Additionally, the study didn’t track other lifestyle changes participants might have made, such as diet modifications or other forms of exercise. So more research is needed to understand the full picture. Nonetheless, our findings provide promising evidence about the benefits of CrossFit that could contribute to reducing the strain on healthcare services.

Athalie Redwood-Brown, PhD, is a Senior Lecturer in Performance Analysis of Sport at Nottingham Trent University. She also operates a Strength and Conditioning facility with her husband.

Jen Wilson, PhD, is a Senior Exercise and Health Practitioner at the Sport and Wellbeing Academy at Nottingham Trent University. She is also a Sports Therapist and Strength and Conditioning Coach.

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

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..

‘Misplaced and Dangerous’ Opioid Study Debunked by Critics

By Pat Anson, PNN Editor

Nearly a year after publishing a controversial study that questioned the effectiveness of opioid pain medication, The Lancet medical journal has published two rebuttal letters that challenge the study’s design and conclusions.

The blinded, placebo-controlled clinical trial – known as the OPAL study -- found that a 6-week course of low-dose oxycodone worked no better than a placebo in treating patients with recent mild-to-moderate back and neck pain. Based on that finding, Australian researchers recommended that opioids should not be used to treat acute back and neck pain, and that medical guidelines should be changed to reflect that view.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney.

“This recommendation is an extraordinary, misplaced, and dangerous conclusion, considering the authors studied the effects of only one type of slow-release opioid not indicated for acute pain and that guidelines should not be changed on the basis of a single randomized trial,” said Asaf Weisman, Dr. Youssef Masharawi and Dr. James Eubanks in their rebuttal letter. 

Weisman is a physiotherapist and spine researcher at Tel Aviv University, Masharawi is a professor of physical therapy at Tel Aviv University, and Eubanks is an assistant professor at the Medical University of South Carolina.    

“Relief of pain is one of the obligations of medical doctors. Despite the documented risks, which cannot be understated, opioids are indispensable for pain management, particularly in cases in which other forms of treatment are ineffective or inadequate,” they wrote. 

The second rebuttal letter noted that the OPAL study had an “extremely high” dropout rate and nearly a quarter of patients in the placebo group were taking opioids when the study began – two factors that confound and weaken the study’s findings. 

“We should be careful when drawing decisive conclusions based on this trial,” wrote Dr. Yu Toda, a palliative care specialist at Japan’s National Cancer Center Hospital. 

In reply to the letters, Lin and her co-authors defended the design of the OPAL study, but agreed the conclusions may have been too broad.

“We agree that we cannot generalize our results to all opioids. There are different opioid classes with different pharmacological profiles,” said Lin. “We agree that the OPAL results might not be generalizable to all patients with acute low back and neck pain, including those experiencing hyperacute pain requiring immediate pain relief in the emergency department.” 

Other critics found additional flaws in the OPAL study, pointing out that the daily dose of oxycodone was relatively low – ranging from 15 to 30 MME (morphine milligram equivalents) -- and that the oxycodone was combined with naloxone, a medication that blocks the effects of opioids. In clinical practice, a slow-release formulation of oxycodone is usually not prescribed for short-term pain and is never combined with naloxone,

Publishing rebuttal letters is a common practice for medical journals, but – until now -- The Lancet has not shared with its readers any counterpoints to the OPAL study

“The Lancet received submitted replies criticizing the OPAL Trial’s authors’ over-generalized conclusion within a month of the study’s online publication. Given evidence for patient harms from excessively rapid dose reductions or discontinuation of opioid therapy, waiting almost a year to publish these criticisms seems recklessly irresponsible,” said Dr. Chad Kollas, a palliative care physician and pain policy expert, whose rebuttal letter was rejected several months ago by The Lancet’s editors.

‘Many Patients Have Been Hurt’

The OPAL study received a fair amount of media attention when it came out and was even hailed as a “Landmark Trial” by some news outlets. But like many news stories dealing with opioids, they conveyed the simplistic message that all opioids are risky and ineffective, regardless of a patient’s condition, pain level or need.

“The Great Opioid Lie: Addictive painkillers do NOT reduce lower back or neck pain,” was the headline used by the Daily Mail. “Opioids might actually worsen pain in the long-run while increasing the odds of becoming addicted.”  

The OPAL study was even cited by U.S. Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) in a letter to the FDA urging the agency not to conduct studies on the efficacy of opioids. Further studies are not needed, they claimed, and would only lead to the approval of new opioid medication.

“A recent randomized placebo-controlled study found that prolonged opioid use was ineffective for acute back and neck pain,” Sens. Markey and Manchin wrote. “For too long, drug manufacturers have been given the benefit of the doubt in developing and marketing a drug that unleashed a widespread, decades-long epidemic. Using a study model that risks continued bias in favor of approval is unacceptable.”

Weisman and his two colleagues say “opioid phobia” in the U.S. has led to pain patients around the world being denied appropriate treatment, causing unnecessary suffering.  

“Unfortunately, the opioid epidemic in the USA has led to many countries adopting strict umbrella policies and led to so-called opioid phobia among clinicians, and many patients worldwide have been hurt due to these processes,” they wrote.

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.