Seniors Surprisingly Eager To Try Virtual Reality Therapy for Pain

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

APPLIEDVR IMAGE

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

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

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

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

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

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

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

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

New Drug Shows Promise in Treating Sjogren's Disease

By Pat Anson, PNN Editor

Sjogren's disease – also known as Sjogren's syndrome – is one of the most frustrating and painful autoimmune conditions. Often accompanied by rheumatoid arthritis, lupus and other immune system disorders, Sjogren's usually begins with dry eyes and a dry mouth, and then slowly progresses to a chronic illness that causes fatigue, muscle and joint pain, and organ damage.

Most frustrating of all is that there are few ways to stop Sjogren's progression and complications that can result in an early death. Eyes drops, anti-inflammatory drugs and pain medication only mask the symptoms temporarily.

“There are currently no disease-modifying therapies for Sjogren's, so current treatment is usually aimed at reducing symptoms," says E. William St. Clair, MD, a Professor in the Division of Rheumatology and Immunology at Duke University School of Medicine.

That could be changing, thanks to a new drug being developed by Amgen and an international research team. In a Phase 2 randomized clinical trial, 183 adult patients with moderate-to-severe Sjogren's received intravenous infusions of dazodalibep (DAZ), a drug that blocks the signals that drive the autoimmune reaction to Sjogren's.

The study findings, published this month in the journal Nature Medicine, show that patients who received DAZ therapy had a significant reduction in disease activity. They also had reduced symptoms of dryness, fatigue and pain.

"This is hopeful news for people with Sjögren's," says Clair, the study’s lead author. "DAZ is the first new drug under development for the treatment of Sjögren's to reduce both systemic disease activity and an unacceptable symptom burden.”

DAZ therapy was generally safe and well tolerated, with mild adverse events such as diarrhea, dizziness, respiratory tract infection, fatigue and hypertension.

Phase 2 studies are only meant to test a drug’s safety and efficacy. Amgen is currently recruiting about 1,000 patients with moderate-to-severe Sjögren's for two larger Phase 3 studies of DAZ therapy. Both are expected to take about two years to complete.  

Dazodalibep is also binge studied as a therapy for rheumatoid arthritis and glomerulosclerosis, a rare kidney disease. The drug was originally developed by Horizon Therapeutics, which Amgen purchased last year for $27.8 billion.

Animals Have Long Used Plants to Treat Pain and Heal Wounds   

By Adrienne Mayor

When a wild orangutan in Sumatra recently suffered a facial wound, apparently after fighting with another male, he did something that caught the attention of the scientists observing him.

The animal chewed the leaves of a liana vine – a plant not normally eaten by apes. Over several days, the orangutan carefully applied the juice to its wound, then covered it with a paste of chewed-up liana. The wound healed with only a faint scar. The tropical plant he selected has antibacterial and antioxidant properties and is known to alleviate pain, fever, bleeding and inflammation.

The striking story was picked up by media worldwide. In interviews and in their research paper, the scientists stated that this is “the first systematically documented case of active wound treatment by a wild animal” with a biologically active plant. The discovery will “provide new insights into the origins of human wound care.”

To me, the behavior of the orangutan sounded familiar. As a historian of ancient science who investigates what Greeks and Romans knew about plants and animals, I was reminded of similar cases reported by Aristotle, Pliny the Elder, Aelian and other naturalists from antiquity.

A remarkable body of accounts from ancient to medieval times describes self-medication by many different animals. The animals used plants to treat illness, repel parasites, neutralize poisons and heal wounds.

The term zoopharmacognosy – “animal medicine knowledge” – was invented in 1987. But as the Roman natural historian Pliny pointed out 2,000 years ago, many animals have made medical discoveries useful for humans. Indeed, a large number of medicinal plants used in modern drugs were first discovered by Indigenous peoples and past cultures who observed animals employing plants and emulated them.

What We Learned by Watching Animals

Some of the earliest written examples of animal self-medication appear in Aristotle’s “History of Animals” from the fourth century BCE, such as the well-known habit of dogs to eat grass when ill, probably for purging and deworming.

Aristotle also noted that after hibernation, bears seek wild garlic as their first food. It is rich in vitamin C, iron and magnesium, healthful nutrients after a long winter’s nap. The Latin name reflects this folk belief: Allium ursinum translates to “bear lily,” and the common name in many other languages refers to bears.

Pliny explained how the use of dittany, also known as wild oregano, to treat arrow wounds arose from watching wounded stags grazing on the herb. Aristotle and Dioscorides credited wild goats with the discovery. Vergil, Cicero, Plutarch, Solinus, Celsus and Galen claimed that dittany has the ability to expel an arrowhead and close the wound. Among dittany’s many known phytochemical properties are antiseptic, anti-inflammatory and coagulating effects.

According to Pliny, deer also knew an antidote for toxic plants: wild artichokes. The leaves relieve nausea and stomach cramps and protect the liver. To cure themselves of spider bites, Pliny wrote, deer ate crabs washed up on the beach, and sick goats did the same. Notably, crab shells contain chitosan, which boosts the immune system.

When elephants accidentally swallowed chameleons hidden on green foliage, they ate olive leaves, a natural antibiotic to combat salmonella harbored by lizards. Pliny said ravens eat chameleons, but then ingest bay leaves to counter the lizards’ toxicity. Antibacterial bay leaves relieve diarrhea and gastrointestinal distress. Pliny noted that blackbirds, partridges, jays and pigeons also eat bay leaves for digestive problems.

Weasels were said to roll in the evergreen plant rue to counter wounds and snakebites. Fresh rue is toxic. Its medical value is unclear, but the dried plant is included in many traditional folk medicines. Swallows collect another toxic plant, celandine, to make a poultice for their chicks’ eyes. Snakes emerging from hibernation rub their eyes on fennel. Fennel bulbs contain compounds that promote tissue repair and immunity.

According to the naturalist Aelian, who lived in the third century BCE, the Egyptians traced much of their medical knowledge to the wisdom of animals. Aelian described elephants treating spear wounds with olive flowers and oil. He also mentioned storks, partridges and turtledoves crushing oregano leaves and applying the paste to wounds.

The study of animals’ remedies continued in the Middle Ages. An example from the 12th-century English compendium of animal lore, the Aberdeen Bestiary, tells of bears coating sores with mullein. Folk medicine prescribes this flowering plant to soothe pain and heal burns and wounds, thanks to its anti-inflammatory chemicals.

Ibn al-Durayhim’s 14th-century manuscript “The Usefulness of Animals” reported that swallows healed nestlings’ eyes with turmeric, another anti-inflammatory. He also noted that wild goats chew and apply sphagnum moss to wounds, just as the Sumatran orangutan did with liana. Sphagnum moss dressings neutralize bacteria and combat infection.

Nature’s Pharmacopoeia

Of course, these premodern observations were folk knowledge, not formal science. But the stories reveal long-term observation and imitation of diverse animal species self-doctoring with bioactive plants. Just as traditional Indigenous ethnobotany is leading to lifesaving drugs today, scientific testing of the ancient and medieval claims could lead to discoveries of new therapeutic plants.

Animal self-medication has become a rapidly growing scientific discipline. Observers report observations of animals, from birds and rats to porcupines and chimpanzees, deliberately employing an impressive repertoire of medicinal substances. One surprising observation is that finches and sparrows collect cigarette butts. The nicotine kills mites in bird nests. Some veterinarians even allow ailing dogs, horses and other domestic animals to choose their own prescriptions by sniffing various botanical compounds.

Mysteries remain. No one knows how animals sense which plants cure sickness, heal wounds, repel parasites or otherwise promote health. Are they intentionally responding to particular health crises? And how is their knowledge transmitted? What we do know is that we humans have been learning healing secrets by watching animals self-medicate for millennia.

Adrienne Mayor is a research scholar in the Classics Department and History and Philosophy of Science Program at Stanford University. She studies the history of "folk science" in ancient myths and oral traditions.

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

Little Evidence That Antidepressants Work for Chronic Pain  

By Drs. Hollie Birkinshaw and Tamar Pincus

About one in five people globally live with chronic pain, and it is a common reason for seeing a doctor, accounting for one in five GP appointments in the UK.

With growing caution around prescribing opioids – given their potential for addiction – many doctors are looking to prescribe other drugs, “off-label”, to treat long-term pain. A popular option is antidepressants.

In the UK, doctors can prescribe the following antidepressants for “chronic primary pain” (pain without a known underlying cause): amitriptyline, citalopram, duloxetine, fluoxetine, paroxetine and sertraline. Amitriptyline and duloxetine are also recommended for nerve pain, such as sciatica.

However, our review of studies investigating the effectiveness of antidepressants at treating chronic pain found that there is only evidence for one of these drugs: duloxetine.

We found 178 relevant studies with a total of 28,664 participants. It is the largest-ever review of antidepressants for chronic pain and the first to include all antidepressants for all types of chronic pain.

Forty-three of the studies (11,608 people) investigated duloxetine (Cymbalta). We found that it moderately reduces pain and improves mobility. It is the only antidepressant that we are certain has an effect. We also found that a 60mg dose of duloxetine was equally effective in providing pain relief as a 120mg dose.

In comparison, while 43 studies also investigated amitriptyline (Elavil), the total number of participants was only 3,372, indicating that most of these studies are very small and susceptible to biased results.

The number of studies and participants for the other antidepressants are:

  • Citalopram (Celexa): five studies with 209 participants

  • Fluoxetine (Prozac): 11 studies with 622 participants

  • Paroxetine (Paxil): nine studies with 960 participants

  • Sertraline (Zoloft): three studies with 210 participants.

The evidence for amitriptyline, citalopram, fluoxetine, paroxetine and sertraline was very poor, and no conclusions could be drawn about their ability to relieve pain.

This is particularly important as UK prescribing data shows 15,784,225 prescriptions of amitriptyline in the last year. It is reasonable to assume that a large proportion of these may be for pain relief because amitriptyline is no longer recommended for treating depression.

This suggests that millions of people may be taking an antidepressant to treat pain even though there is no evidence for its usefulness. In comparison, 3,973,129 duloxetine prescriptions were issued during the same period, for a mixture of depression and pain.

In light of our findings, which were published in May 2023, the UK’s National Institute for Health and Care Excellence (Nice) recently updated its advice to doctors on how to treat chronic pain.

The updated Nice guidance now suggests 60mg of duloxetine to treat [chronic primary pain] and the same drug and dose to treat nerve pain.

Limited Treatments Options

GPs often report frustration at the limited options available to them to treat patients experiencing chronic pain. Amitriptyline is cheap to prescribe – only 66p per pack (US 82.5 cents) – which may explain the high number of prescriptions for this drug.

This is an example of how the gap between evidence and clinical practice could harm patients. Although our review was unable to establish the long-term safety of antidepressant use, previous research has highlighted the high rates of side-effects for amitriptyline, including dizziness, nausea, headaches and constipation.

It’s important to bear in mind, though, that pain is a very individual experience, and the evidence in our review is based on groups of people. We acknowledge that certain drugs may work for people even when the research evidence is inconclusive or unavailable. If you have any concerns about your pain medication, you should discuss this with your doctor.

Hollie Birkinshaw, PhD, is a Research Fellow at University of Southampton. She specializes in research involving chronic musculoskeletal pain, and the integration of psychology in pain and health services. Birkinshaw receives funding from the UK’s National Institute for Health and Care Research (NIHR).

Tamar Pincus, PhD, is a Professor of Health Psychology at University of Southampton. Her research focuses on the psychological aspects of chronic pain. Pincus receives funding from NIHR, Medical Research Council and Versus Arthritis.  

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

Support for Spouse with Chronic Pain Is Helpful, But Not Always Welcome

By Pat Anson, PNN Editor

Support for a spouse or romantic partner with chronic pain can help reduce depression and improve their mood, according to new study. But researchers say some people in pain have poor psychological health regardless of the support they receive.     

A Penn State research team conducted a series of interviews with 152 long-term couples over the age of 50 in which one of the partners had knee pain from osteoarthritis.

Nearly 40% of middle-aged Americans have knee osteoarthritis, a progressive and painful joint disorder that causes thinning of cartilage and joint damage. The condition is strongly associated with early death, high blood pressure, diabetes and cardiovascular disease, particularly in women.

“Osteoarthritis in the knee can be a challenging condition,” lead author Suyoung Nah, PhD, said in a press release “People with the condition will eventually need support managing their pain. What is more, they are likely to continue needing assistance managing their pain for the rest of their lives.”

Nah and her colleagues asked each couple about the pain management support they received from a spouse or partner, such as assistance in taking pain medication or help standing up.

Most participants who received good support felt loved and grateful, and had fewer signs of depression; while those who felt a lack of support had more negative moods and were more likely to be depressed.

A small group of respondents reported feeling angry or resentful — even when they received good support from a partner.

“Almost everyone has times in their life when they do not want to accept help because it makes them feel helpless or because they think they do not need it,” said co-author Lynn Martire, PhD, a Professor of Human Development and Family Studies at Penn State’s Center for Healthy Aging.

Researchers wanted to see if people’s perceptions of the support they receive changed over time, so 18 months later they surveyed the same couples again. Those who felt anger or resentment at the start of the study – regardless of the support they received -- continued having negative moods.

That finding demonstrates the need for good communication between couples when one partner has chronic pain. Providing support – and accepting it -- can be complicated in those relationships.

“Receiving care is not always beneficial to every aspect of a person’s life,” said Nah, who is currently a Postdoctoral Fellow at the Virginia Tech Center for Gerontology. “Additionally, it may be difficult for couples to discuss and negotiate care. As a society, we need to make sure that older people understand their partner’s needs and desires regarding care so that both partners can maximize their physical, emotional and relational quality of life.”

Previous research by Martire found that couples typically don’t have conversations about the type of support that is wanted or needed. Clear communication about expectations and feelings can improve the quality of life for a partner who needs care.

“My main interest is in late-life family relationships — especially couples — navigating chronic illness,” Martire said. “Most older adults have at least two or three chronic illnesses, so helping them find better ways to help each other is really important.”

The study was published in Journal of Aging and Health.

A 2017 study found that criticism from a spouse can make chronic back pain worse. People with back pain who felt they were criticized had more anxiety, anger and sadness, and their pain levels increased for as long as three hours. The study also found that when a partner was supportive – expressing concern about a spouse’s pain or giving “helpful” suggestions – the interaction was still perceived as negative by some pain sufferers.

Millions Lose Medicaid Benefits, Including Disabled

By Daniel Chang, KFF Health News

Jacqueline Saa has a progressive genetic condition called Ehlers-Danlos syndrome that leaves her unable to stand, walk on her own, or hold a job.

Every weekday for four years, Saa, 43, has relied on a home health aide to help her cook, bathe and dress, go to the doctor, pick up medications, and accomplish other daily tasks. She received coverage through Florida’s Medicaid program, until it abruptly stopped at the end of March.

“Every day the anxiety builds,” said Saa, who lost her home health aide for 11 days, starting April 1, despite being eligible.

The state has since restored Saa’s home health aide service, but during the gap she leaned on her mother and her 23- and 15-year-old daughters, while struggling to regain her Medicaid benefits.

“It’s just so much to worry about,” she said. “This is a health care system that’s supposed to help.”

Medicaid’s home and community-based services are designed to help people like Saa, who have disabilities and need help with everyday activities, stay out of a nursing facility

JACQUELINE SAA

But people are losing benefits with little or no notice, getting bad advice when they call for information, and facing major disruptions in care while they wait for the issue to get sorted out, according to attorneys and advocates who are hearing from patients.

In Colorado, Texas, and Washington, D.C., the National Health Law Program, a nonprofit that advocates for low-income and underserved people, has filed civil rights complaints with two federal agencies alleging discrimination against people with disabilities. The group has not filed a lawsuit in Florida, though its attorneys say they’ve heard of many of the same problems there.

Attorneys nationwide say the special needs of disabled people were not prioritized as states began to review eligibility for Medicaid enrollees after a pandemic-era mandate for coverage expired in March 2023.

“Instead of monitoring and ensuring that people with disabilities could make their way through the process, they sort of treated them like everyone else with Medicaid,” said Elizabeth Edwards, a senior attorney for the National Health Law Program. Federal law puts an “obligation on states to make sure people with disabilities don’t get missed.”

At least 21 million people nationwide have been disenrolled from Medicaid since states began eligibility redeterminations in spring 2023, according to a KFF analysis.

The unwinding, as it’s known, is an immense undertaking, Edwards said, and some states did not take extra steps to set up a special telephone line for those with disabilities, for example, so people could renew their coverage or contact a case manager.

As states prepared for the unwinding, the Centers for Medicare & Medicaid Services, the federal agency that regulates Medicaid, advised states that they must give people with disabilities the help they need to benefit from the program, including specialized communications for people who are deaf or blind.

The Florida Department of Children and Families, which verifies eligibility for the state’s Medicaid program, has a specialized team that processes applications for home health services, said Mallory McManus, the department’s communications director.

People with disabilities disenrolled from Medicaid services were “properly noticed and either did not respond timely or no longer met financial eligibility requirements,” McManus said, noting that people “would have been contacted by us up to 13 times via phone, mail, email, and text before processing their disenrollment.”

Benefits Cut Without a Call

Allison Pellegrin of Ormond Beach, Florida, who lives with her sister Rhea Whitaker, who is blind and cognitively disabled, said that never happened for her family.

“They just cut off the benefits without a call, without a letter or anything stating that the benefits would be terminating,” Pellegrin said.

Her sister’s home health aide, whom she had used every day for nearly eight years, stopped service for 12 days.

“If I’m getting everything else in the mail,” she said, “it seems weird that after 13 times I wouldn’t have received one of them.”

Pellegrin, 58, a sales manager who gets health insurance through her employer, took time off from work to care for Whitaker, 56, who was disabled by a severe brain injury in 2006.

Medicaid reviews have been complicated, in part, by the fact that eligibility works differently for home health services than for general coverage, based on federal regulations that give states more flexibility to determine financial eligibility. Income limits for home health services are higher, for instance, and assets are counted differently.

RHEA WHITAKER

In Texas, a parent in a household of three would be limited to earning no more than $344 a month to qualify for Medicaid. And most adults with a disability can qualify without a dependent child and be eligible for Medicaid home health services with an income of up to $2,800 a month.

The state was not taking that into consideration, said Terry Anstee, a supervising attorney for community integration at Disability Rights Texas, a nonprofit advocacy group.

Even a brief lapse in Medicaid home health services can fracture relationships that took years to build.

“It may be very difficult for that person who lost that attendant to find another attendant,” Anstee said, because of workforce shortages for attendants and nurses and high demand.

Nearly all states have a waiting list for home health services. About 700,000 people were on waiting lists in 2023, most of them with intellectual and developmental disabilities, according to KFF data.

Daniel Tsai, a deputy administrator at CMS, said the agency is committed to ensuring that people with disabilities receiving home health services “can renew their Medicaid coverage with as little red tape as possible.”

CMS finalized a rule this year for states to monitor Medicaid home health services. For example, CMS will now track how long it takes for people who need home health care to receive the services and will require states to track how long people are on waitlists.

Staff turnover and vacancies at local Medicaid agencies have contributed to backlogs, according to complaints filed with two federal agencies focused on civil rights.

The District of Columbia’s Medicaid agency requires that case managers help people with disabilities complete renewals. However, a complaint says, case managers are the only ones who can help enrollees complete eligibility reviews and, sometimes, they don’t do their jobs.

Advocates for Medicaid enrollees have also complained to the Federal Trade Commission about faulty eligibility systems developed by Deloitte, a global consulting firm that contracts with about two dozen states to design, implement, or operate automated benefits systems.

KFF Health News found that multiple audits of Colorado’s eligibility system, managed by Deloitte, uncovered errors in notices sent to enrollees. A 2023 review by the Colorado Office of the State Auditor found that 90% of sampled notices contained problems, some of which violate the state’s Medicaid rules. The audit blamed “flaws in system design” for populating notices with incorrect dates.

Deloitte declined to comment on specific state issues.

In March, Colorado officials paused disenrollment for people on Medicaid who received home health services, which includes people with disabilities, after a “system update” led to wrongful terminations in February.

Another common problem is people being told to reapply, which immediately cuts off their benefits, instead of appealing the cancellation, which would ensure their coverage while the claim is investigated, said attorney Miriam Harmatz, founder of the Florida Health Justice Project.

“What they’re being advised to do is not appropriate. The best way to protect their legal rights,” Harmatz said, “is to file an appeal.”

‘So Many People Are Calling’

But some disabled people are worried about having to repay the cost of their care. Saa, who lives in Davie, Florida, received a letter shortly before her benefits were cut that said she “may be responsible to repay any benefits” if she lost her appeal.

The state should presume such people are still eligible and preserve their coverage, Harmatz said, because income and assets for most beneficiaries are not going to increase significantly and their conditions are not likely to improve.

The Florida Department of Children and Families would not say how many people with disabilities had lost Medicaid home health services.

But in Miami-Dade, Florida’s most populous county, the Alliance for Aging, a nonprofit that helps older and disabled people apply for Medicaid, saw requests for help jump from 58 in March to 146 in April, said Lisa Mele, the organization’s director of its Aging and Disability Resources Center.

“So many people are calling us,” she said.

States are not tracking the numbers, so “the impact is not clear,” Edwards said. “It’s a really complicated struggle.”

Saa filed an appeal March 29 after learning from her social worker that her benefits would expire at the end of the month. She went to the agency but couldn’t stand in a line that was 100 people deep. Calls to the state’s Medicaid eligibility review agency were fruitless, she said.

“When they finally connected me to a customer service representative, she was literally just reading the same explanation letter that I’ve read,” Saa said. “I did everything in my power.”

Saa canceled her home health aide. She lives on limited Social Security disability income and said she could not afford to pay for the care.

On April 10, she received a letter from the state saying her Medicaid had been reinstated, but she later learned that her plan did not cover home health care.

The following day, Saa said, advocates put her in touch with a point person at Florida’s Medicaid agency who restored her benefits. A home health aide showed up April 12. Saa said she’s thankful but feels anxious about the future.

“The toughest part of that period is knowing that that can happen at any time,” she said, “and not because of anything I did wrong.”

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

Non-Opioid Analgesic Gets Another Poor Grade for Pain Relief

By Pat Anson, PNN Editor

An expensive analgesic drug that’s often touted as a safer alternative to opioids is not reliable or effective as a pain reliever, according to a new study.

Exparel is an injectable form of liposomal bupivacaine, a non-opioid local anesthetic used for post-operative pain and as a nerve block to numb parts of the body during surgery.

Because Exparel is a proprietary formulation of bupivacaine, Pacira BioSciences has priced it 10 times higher than generic bupivacaine. A 20 milliliter vial of Exparel costs about $376, compared to $38 for a same size vial of bupivacaine.

Some anesthesiologists have questioned whether Exparel is actually worth the higher cost, saying its effectiveness in relieving post-operative pain is “clinically unimportant” and no different than other local anesthetics.  

To see if they might be right, researchers at the Medical University of Vienna recruited 25 healthy volunteers for a blinded clinical study in which participants received two nerve blocks about a month apart, one with plain bupivacaine for pain control and the other with liposomal bupivacaine (Exparel).

"Since the combination of both forms of bupivacaine is recommended, little was known about the effectiveness of the use of liposomal bupivacaine alone in pain therapy during and immediately after surgery," wrote lead author Peter Marhofer, MD, a Professor of Anesthesia and Intensive Care Medicine at MedUni Vienna.

The study findings, recently published in the journal Anesthesiology, show that Exparel alone blocked pain in less than a third of the volunteers, compared to everyone who received plain bupivacaine.

“Given complete sensory blockade in merely 32% of cases, as compared to 100% with plain bupivacaine, liposomal bupivacaine does not emerge from our study as a suitable ‘sole’ local anesthetic for intraoperative regional anesthesia,” said Marhofer.

Those who did get pain relief from Exparel say it reduced their post-operative pain for up to 3.5 days. But because its effects varied widely from subject to subject, researchers don’t consider it a reliable analgesic when used alone.

"Our study showed unpredictable effects of liposomal bupivacaine in terms of nerve block and associated pain relief. Based on our findings, the substance cannot currently be recommended for use in pain therapy during and after surgery," said co-author Markus Zeitlinger, MD, an Associate Professor of Clinical Pharmacology at MedUni Vienna.

Pacira did not respond to a request from PNN for comment on the study. In the past, the company has aggressively promoted Exparel and used hardball tactics to silence critics.

In 2021, Pacira filed a lawsuit against the American Society of Anesthesiologists for publishing “false and misleading conclusions” in the journal Anesthesiology that said Exparel worked no better than other bupivacaine products. The lawsuit was later dropped.

In 2014, Pacira took the unusual step of filing a lawsuit against the FDA, after the agency sent a warning letter to Pacira for off-label marketing of Exparel. Pacira won that case in an out-of-court settlement when the FDA withdrew its warning letter and approved the use of Exparel for more types of post-operative pain.

Over the years, Pacira has paid nearly $34 million to doctors to help promote Exparel, according to Open Payments. That strategy backfired In 2020, when Pacira paid $3.5 million to settle allegations that it gave kickbacks to doctors in the form of fake research grants.

Pacira has also been active politically, spending over $3 million on lobbying and campaign donations since 2018, according to OpenSecrets. In 2019, the company hired former New Jersey governor Chris Christie as a consultant for $800,000 and lucrative stock options. Christie had recently chaired President Trump’s opioid commission, which issued a report recommending that hospitals use more non-opioid pain relievers.

Pacira is also bankrolling Voices for Non-Opioid Choices, an advocacy group that is lobbying the Biden administration for early implementation of the NOPAIN Act. Passed by Congress in late 2022, the law requires Medicare and Medicaid to pay for Exparel and other non-opioid treatments in outpatient surgical settings, starting in 2025. Supporters of the bill want the timetable moved up to 2024, which would generate millions of dollars in additional revenue for Pacira. 

Regulations Should Be Eased for Cannabis and Psilocybin

By Dr. Kevin Boehnke  

The U.S. Drug Enforcement Agency announced in late April 2024 that it plans to ease federal restrictions on cannabis, reclassifying it from a Schedule I drug to the less restricted Schedule III, which includes drugs such as Tylenol with codeine, testosterone and other anabolic steroids. This historic shift signals an acknowledgment of the promising medicinal value of cannabis.

The move comes in tandem with growing interest in the use of psilocybin, the active component in magic mushrooms, for treatment of depression, chronic pain and other conditions. In 2018 and 2019, the U.S. Food and Drug Administration granted a breakthrough therapy designation to psilocybin, meant to expedite drug development given that preliminary studies suggest it may have substantial therapeutic value over currently available therapies for treatment-resistant depression and major depressive disorder.

Both of these developments represent a dramatic change from long-standing federal policy around these substances that has historically criminalized their use and blocked or delayed research efforts into their therapeutic potential.

As an assistant professor of anesthesiology and a pain researcher, I study alternative pain management options, including cannabis and psychedelics.

I also have a personal stake in improving chronic pain treatment: In early 2009 I was diagnosed with fibromyalgia, a condition characterized by widespread pain throughout the body, sleep disturbances and generalized sensory sensitivity.

I have seen and experienced firsthand the ways that clinicians and patients talk about chronic pain medications, and find them to generally be disempowering to the patient, clinician, and drugs themselves. My goal in this article is to help provide a new and more useful lens to think about medications, especially given the poor treatment outcomes for people with chronic pain, the frustration providers express about treating these ‘challenging patients,’ and the ongoing opioid overdose crisis.

I see cannabis and psilocybin as promising therapies that can contribute to bridging that need. Given that an estimated 50 million Americans have chronic pain – meaning pain that persists for three months or more – I want to help understand how to effectively use cannabis and psilocybin as potential tools for pain management.

Cannabis History

Cannabis, also known as marijuana, is an ancient medicinal plant. Cannabis-based medicines have been used for at least 5,000 years for applications such as arthritis and pain control during and after surgery.

This use extended through antiquity to modern times, with contemporary cannabis-based medications for treating certain seizure disorders, promoting weight gain for HIV/AIDS-related anorexia and treating nausea during chemotherapy.

As with anything you put in your body, cannabis does have health risks: Driving while high may increase risk of accidents. Some people develop cyclical vomiting, while others develop motivation or dependence problems, especially with heavy use at younger ages.

That said, lethal overdoses from cannabis are almost unheard of. This is remarkable considering that nearly 50 million Americans use it each year.

In contrast, opioids, which are often prescribed for chronic pain, have contributed to hundreds of thousands of overdose deaths over the past few decades. Even common pain medications like nonsteroidal anti-inflammatory drugs, such as ibuprofen, cause tens of thousands of hospitalizations and thousands of deaths each year from gastrointestinal damage.

Furthermore, both opioids and nonopioid pain medications have limited effectiveness for treating chronic pain. Medications used for chronic pain can provide small to moderate pain relief in some people, but many ultimately cause side effects that outweigh any gains.

These safety issues and limited benefit have led many people with chronic pain to try cannabis as a chronic pain treatment alternative. Indeed, in survey studies, my colleagues and I show that people substituted cannabis for pain medications often because cannabis had fewer negative side effects.

However, more rigorous research on cannabis for chronic pain is needed. So far, clinical trials – considered the gold standard – have been short in length and focused on small numbers of people. What’s more, my colleagues and I have shown that these studies employ medications and dosing regimes that are far different from how consumers actually use products from state-licensed cannabis dispensaries. Cannabis also causes recognizable effects such as euphoria, altered perceptions and thinking differently, so it is difficult to conduct double-blind studies.

Despite these challenges, a group of cannabis and pain specialists published a proposed guideline for clinical practice in early 2024 to synthesize existing evidence and help guide clinical practice. This guideline recommended that cannabis products be used when pain is coupled with sleep problems, muscle spasticity and anxiety. These multiple benefits mean that cannabis could potentially help people avoid taking a separate medication for each symptom.

Since the Controlled Substance Act was passed in 1970, the federal government has designated cannabis as a Schedule I substance, along with other drugs such as heroin and LSD. Possession of these drugs is criminalized, and under the federal definition they have “no currently accepted medical use, with a high potential for abuse.” Because of this designation and the limits placed on drug manufacturing, cannabis is very difficult to study.

State and federal regulatory barriers also delay or prevent studies from being approved and conducted. For example, I can purchase cannabis from state-licensed dispensaries in my hometown of Ann Arbor, Michigan. As a scientist, however, it is very challenging to legally test whether these products help pain.

Reclassifying cannabis as a Schedule III drug has the potential to substantially open up this research landscape and help overcome these barriers.

Emerging Role of Psychedelics

Psychedelics, such as psilocybin-containing mushrooms, occupy an eerily similar scientific and political landscape as cannabis. Used for thousands of years for ceremonial and healing purposes, psilocybin is also classified as a Schedule I drug. It can cause substantial changes in sensory perception, mood and sense of self that can lead to therapeutic benefits. And, like cannabis, psilocybin has minimal risk of lethal overdose.

Clinical trials combining psilocybin with psychotherapy in the weeks before and after taking the drug report substantial improvements in symptoms of psychiatric conditions such as treatment-resistant depression and alcohol use disorder.

Risks are typically psychological. A small number of people report suicidal thoughts or self-harm behaviors after taking psilocybin. Some also experience heightened openness and vulnerability, which can be exploited by therapists and lead to abuse.

There are few published clinical trials of psilocybin therapy for chronic pain, although many are ongoing, including a pilot study for fibromyalgia conducted by our team at the University of Michigan. This treatment may help people develop a healthier relationship with their pain by eliciting greater acceptance of it and decreasing rumination often related to negative thoughts and feelings around pain.

As with cannabis, some states, such as Colorado and Oregon, have decriminalized psilocybin and are building infrastructure to increase accessibility to psilocybin-assisted therapy. One recent analysis suggests that if psychedelics follow a similar legalization pattern to cannabis, the majority of states will legalize psychedelics between 2034 and 2037.

Challenges Ahead

These ancient yet relatively “new” treatments offer a unique glimpse into the messy intersection of drugs, medicine and society. The justifiable excitement about cannabis and psilocybin has led to state policies that have increased access for some people, yet federal criminalization and substantial barriers to scientific investigation remain. In the years ahead, I hope to contribute toward pragmatic studies that work within these difficult parameters.

For example, our team developed a coaching intervention to help veterans use commercially available cannabis products to more effectively treat their pain. Coaches emphasize how judicious use can minimize side effects while maximizing benefits. Should our approach work, health care providers and cannabis dispensaries everywhere could use this treatment to help clients in chronic pain.

Approaches like these can supplement more traditional clinical trials to help researchers determine whether these drug classes offer benefit and whether they have comparable or less harm than current treatments. As our society connects to the rich history of healing using these ancient drugs, these proposed changes may offer safer and substantive options for the 50 million Americans living with chronic pain.

Kevin F. Boehnke, PhD, is an Assistant Professor in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at the University of Michigan.  He receives funding from the National Institutes of Health, the State of Michigan Veteran Marijuana Research Program, and has received grants from Tryp Therapeutics and Journey Biosciences.

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

Wild Orangutan Used Plant as Pain Reliever

By Pat Anson, PNN Editor

Humans have used natural remedies like cannabis, kratom and willow trees for thousands of years for pain relief. But other primates may have beaten us to the punch when it comes to using plants as medicine.

That’s one of the theories emerging after a wild orangutan in Indonesia was observed using a plant to help heal a facial wound. The orangutan, named Rakus by scientists, lost a chunk of flesh below his right eye, apparently during a fight with another male orangutan.

A wound like that could easily become infected in the damp rain forests of Sumatra, but Rakus had other ideas.

Scientists observed Rakus rubbing sap from a flowering vine called liana (Fibraurea tinctoria) directly on the wound and then chewing on its leaves to create a paste that he applied over the wound as a poultice.

Scientists say the wound never became infected and within a few days was completely healed.

Since liana leaves are not typically eaten by orangutans as food, it’s believed to be the first time that a big ape was observed self-medicating.

“The behavior of Rakus appeared to be intentional as he selectively treated his facial wound on his right flange, and no other body parts, with the plant juice. The behavior was also repeated several times, not only with the plant juice but also later with more solid plant material until the wound was fully covered. The entire process took a considerable amount of time,” says Isabelle Laumer, PhD, a researcher at the Max Planck Institute of Animal Behavior in Germany.

“Interestingly, Rakus also rested more than usual when being wounded. Sleep positively affects wound healing as growth hormone release, protein synthesis and cell division are increased during sleep.”

Rakus’ behavior raises several intriguing questions. Did he discover the healing powers of lianas on his own? Or was it something he learned from other orangutans and was passed down, from one big ape to another, over generations?

Indigenous people in Southeast Asia also use lianas as medicine. Are the plant’s medicinal properties something they learned while watching orangutans?

“This and related liana species that can be found in tropical forests of Southeast Asia are known for their analgesic and antipyretic (fever reducing) effects and are used in traditional medicine to treat various diseases, such as malaria,” said Laumer, who reported her findings in the journal Scientific Reports.

Like kratom, the pain-relieving effects of lianas comes from chemical compounds called alkaloids, which act on opioid receptors in the brain. The alkaloids in lianas also have antibacterial, anti-inflammatory, anti-fungal, and antioxidant properties that promote wound healing. In Borneo, native people have even used Fibraurea tinctoria to treat diabetes.

“It shows that orangutans and humans share knowledge. Since they live in the same habitat, I would say that’s quite obvious, but still intriguing to realize,” said co-author Caroline Schuppli, PhD, a primatologist at the Max Planck Institute.

“As forms of active wound treatment are not just human, but can also be found in both African and Asian great apes, it is possible that there exists a common underlying mechanism for the recognition and application of substances with medical or functional properties to wounds and that our last common ancestor already showed similar forms of ointment behavior.”

We only know about Rakus because he lives in an animal sanctuary where orangutans are closely monitored. In 21 years of observation, scientists there have not seen any other orangutans treat their wounds with lianas, although that may be due to the fact that they are solitary animals who spend most of their lives in trees and injured ones are rarely seen.    

Schuppli says Rakus may have learned how to treat his wound from his mother, by observing other orangutans, or through “individual innovation.” Orangutans eat hundreds of different fruits and plants, and it’s possible Rakus just stumbled onto the right one at the right time.

“As Fibraurea tinctoria has potent analgesic effects, individuals may feel an immediate pain release, causing them to repeat the behavior several times,” she said.   

How ‘Injectrode’ Could Change Treatment of Chronic Pain

By Pat Anson, PNN Editor

An experimental “injectrode” is showing potential as a new neuromodulation treatment for chronic pain, after the first human clinical trial demonstrated the device’s safety and effectiveness in stimulating nerves in the lower back.

The injectrode is a thin and flexible lead wire that is injected by a needle through the skin and placed near an injured nerve. The wire can then be charged by an externally worn stimulator that sends mild electrical impulses to the nerve to block pain signals.

The injectrode is being developed by Cleveland-based Neuronoff, Inc. as a treatment for many types of chronic pain, such as peripheral nerve pain, phantom limb pain and lower back pain. It all depends on the nerve being targeted.

“You can treat knee pain, shoulder pain, lower back pain by stimulating nerve fibers that are providing proprioceptive input sensory input into the spine and thereby help with a reduction of pain perception,” said Manfred Franke, CEO of Neuronoff, who compares the injectrode wire to a Slinky, a toy once popular with Baby Boomers.

“It’s like a spring, like a Slinky, that’s stuck inside a needle,“ he told PNN. “And when that Slinky comes out of the needle, it folds over and it can conform to the anatomy. If you want to take out the injectrode, all you have to do is pull at any point along its length and then the entire injectrode will come out. Nothing is at risk of being left behind.”

This video produced by Neuronoff demonstrates how the device is injected:

Because the injectrode is easy to install in an out-patient procedure, it could potentially be a low-cost competitor to more invasive neuromodulation devices, such as spinal cord stimulators, and reduce the need for pain medication, steroid injections and procedures such as nerve ablation.

“The injectrode represents a paradigm shift in the field of neuromodulation. Its unique flexible design allows for optimal customization to the patient's anatomy and has the potential to be both a temporary and permanent solution without an internal pulse generator,” said Hesham Elsharkawy, MD, an anesthesiologist and clinical advisor to Neuronoff. “The entire procedure takes just 5-10 minutes, making it highly efficient and accessible for patients seeking relief from chronic pain."

In the investigational pilot study, 10 healthy volunteers had injectrodes placed in their lower back and tested. After 30 days, there were no serious adverse events and the injectrodes were removed without analgesics or sutures.

Because the injectrodes work similarly to transcutaneous electrical nerve stimulators (TENS) already on the market, Franke is hopeful the devices will be cleared by the FDA for marketing without more clinical trials, perhaps as soon as early 2025. The key will being getting insurers to cover the injectrodes, which will cost a few thousand dollars, far less than spinal cord stimulators.

“Which is an advantage to the insurance company. And any advantage that you can provide to the insurance company is a benefit for the patient because you're more likely to be receiving prior approval,” Franke said. “The goal is to be cost efficient enough to the insurance companies, so you can replace repeat drug injections or nerve ablations.”   

In addition to pain, Franke says the electrodes have the potential to treat other medical conditions, such as overactive bladders and hypertension. In tests on animals, the devices significantly lowered blood pressure when they stimulated nerves in the neck.

Low-Carb Diets More Effective than Medication for IBS

By Pat Anson, PNN Editor

Diets low in carbohydrates are more effective than medication in treating irritable bowel syndrome (IBS), according to a new study that found over 70% patients had significantly reduced symptoms after changing their eating habits.

IBS is an intestinal condition that causes abdominal pain, cramps, bloating, gas and diarrhea. An imbalance in gut bacteria is suspected as a possible cause of IBS, and symptoms can be aggravated by stress or eating a large meal.

Researchers at the University of Gothenburg in Sweden enrolled over 300 people with severe or moderate IBS symptoms in a randomized clinical trial, dividing them into three groups.

The first group was given traditional IBS dietary advice, while also focusing on a low intake of fermentable carbohydrates, known as FODMAPs. Foods such as lactose, legumes, onions and whole grains were avoided because they are poorly digested, tend to ferment in the colon, and cause IBS pain.

The second group also had a diet low in carbohydrates, but high in protein and fat. In the third group, there were no dietary changes and laxatives, antidiarrheals, antibiotics and other medications were given based on the patient's symptoms. The treatment period for all three groups was four weeks.

The study findings, published in The Lancet Gastroenterology & Hepatology, show that 76% of participants in the FODMAP group had significantly reduced IBS symptoms. That compares to 71% of patients in the low-carb/high protein and fat group, and only 58% in the medication-only group. All three groups reported better quality of life, and less anxiety and depression.

Even after six months, when participants partially returned to their previous eating habits, a large proportion still had significant symptom relief: 68% in the FODMAP group and 60% in the low-carb/high protein and fat group.

“Although we found evidence that dietary treatments were more efficacious than medical treatment after 4 weeks, all three treatment options showed significant and clinically meaningful efficacy,” wrote lead author Sanna Nybacka, PhD, a researcher and dietician at the University of Gothenburg.

“The sustained positive effects of dietary interventions suggest their potential as first-line treatments for IBS, although patient preference, compliance, cost-effectiveness, and effects on nutritional status and the gut microbiota would need to be accounted for.”

Dietary advice for IBS typically includes sitting down during meals, chewing foods thoroughly, and avoiding excessive intake of coffee, alcohol, fizzy drinks, and fatty or spicy foods.

Foods low in FODMAPs include rice, potatoes, quinoa, and gluten-free pasta and bread, as well as a variety of vegetables, fruits, fish, beef and chicken.

Red Cabbage Juice Improves Gut Health

A new study by researchers at the University of Missouri found that juice from red cabbage can also improve gut health and ease inflammation in the digestive tract caused by Inflammatory Bowel Disease (IBD).

Symptoms of IBD and IBS are similar, but in IBD they become chronic, causing anemia, bleeding, weight loss and fever. About three million Americans live with IBD, including Crohn’s disease and ulcerative colitis.

In studies on laboratory mice with IBD, red cabbage juice relieved their intestinal inflammation. Mice are often used to study IBD because colitis in mice closely resembles ulcerative colitis in humans.

“Red cabbage juice alters the composition of gut microbiota by increasing the abundance of good bacteria, resulting in increased production of short chain fatty acids and other bacteria derived metabolites ameliorating inflammation,” said lead author Satyanarayana Rachagani, PhD, an Associate Professor of Veterinary Medicine & Surgery at the University of Missouri

“Its ability to modulate gut microbiota, activate anti-inflammatory pathways and enhance immune regulation underscores its potential as a valuable therapeutic agent for IBD and related inflammatory disorders.”

The study is published in the International Journal of Molecular Sciences.

Red cabbage juice is rich in antioxidants and Vitamin C, and has long been used as a natural remedy to reduce inflammation and improve overall health. It is also a good source of dietary fiber.

Few Take Advantage of Medicare’s Chronic Care Program

By Phil Galewitz and Holly Hacker, KFF Health News

Carrie Lester looks forward to the phone call every Thursday from her doctors’ medical assistant, who asks how she’s doing and if she needs prescription refills. The assistant counsels her on dealing with anxiety and her other health issues.

Lester credits the chats for keeping her out of the hospital and reducing the need for clinic visits to manage chronic conditions including depression, fibromyalgia, and hypertension.

“Just knowing someone is going to check on me is comforting,” said Lester, 73, who lives with her dogs, Sophie and Dolly, in Independence, Kansas.

At least two-thirds of Medicare enrollees have two or more chronic health conditions, federal data shows. That makes them eligible for a federal program that, since 2015, has rewarded doctors for doing more to manage their health outside office visits.

But while early research found the service, called Chronic Care Management, reduced emergency room and in-patient hospital visits and lowered total health spending, uptake has been sluggish.

Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis.

About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. By comparison, federal data shows about 1 million providers participate in Medicare.

Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021.

Through the CCM program, Medicare pays to develop a patient care plan, coordinate treatment with specialists, and regularly check in with beneficiaries. Medicare pays doctors a monthly average of $62 per patient, for 20 minutes of work with each, according to companies in the business.

Without the program, providers often have little incentive to spend time coordinating care because they can’t bill Medicare for such services.

‘It Was Put Together Wrong’

Health policy experts say a host of factors limit participation in the program. Chief among them is that it requires both doctors and patients to opt in. Doctors may not have the capacity to regularly monitor patients outside office visits. Some also worry about meeting the strict Medicare documentation requirements for reimbursement and are reluctant to ask patients to join a program that may require a monthly copayment if they don’t have a supplemental policy.

“This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”

He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.

For patients, the CCM program is intended to expand the type of care offered in traditional, fee-for-service Medicare to match benefits that — at least in theory — they may get through Medicare Advantage, which is administered by private insurers.

But the CCM program is open to both Medicare and Medicare Advantage beneficiaries.

The program was also intended to boost pay to primary care doctors and other physicians who are paid significantly less by Medicare than specialists, said Mark Miller, a former executive director of the Medicare Payment Advisory Commission, which advises Congress. He’s currently an executive vice president of Arnold Ventures, a philanthropic organization focused on health policy. (The organization has also provided funding for KFF Health News.)

Despite the allure of extra money, some physicians have been put off by the program’s upfront costs.

“It may seem like easy money for a physician practice, but it is not,” said Namirah Jamshed, a physician at UT Southwestern Medical Center in Dallas.

Jamshed said the CCM program was cumbersome to implement because her practice was not used to documenting time spent with patients outside the office, a challenge that included finding a way to integrate the data into electronic health records. Another challenge was hiring staff to handle patient calls before her practice started getting reimbursed by the program.

Only about 10% of the practice’s Medicare patients are enrolled in CCM, she said.

Jamshed said her practice has been approached by private companies looking to do the work, but the practice demurred out of concerns about sharing patients’ health information and the cost of retaining the companies. Those companies can take more than half of what Medicare pays doctors for their CCM work.

Physician Jennifer Bacani McKenney, who runs a family medicine practice in Fredonia, Kansas, with her father — where Carrie Lester is a patient — said the CCM program has worked well.

She said having a system to keep in touch with patients at least once a month has reduced their use of emergency rooms — including for some who were prone to visits for nonemergency reasons, such as running out of medication or even feeling lonely. The CCM funding enables the practice’s medical assistant to call patients regularly to check in, something it could not afford before.

For a small practice, having a staffer who can generate extra revenue makes a big difference, McKenney said.

While she estimates about 90% of their patients would qualify for the program, only about 20% are enrolled. One reason is that not everyone needs or wants the calls, she said.

Outsourcing Chronic Care

While the program has captured interest among internists and family medicine doctors, it has also paid out hundreds of thousands of dollars to specialists, such as those in cardiology, urology, and gastroenterology, the KFF Health News analysis found. Primary care doctors are often seen as the ones who coordinate patient care, making the payments to specialists notable.

A federally funded study by Mathematica in 2017 found the CCM program saves Medicare $74 per patient per month, or $888 per patient per year — due mostly to a decreased need for hospital care.

The study quoted providers who were unhappy with attempts to outsource CCM work. “Third-party companies out there turn this into a racket,” the study cited one physician as saying, noting companies employ nurses who don’t know patients.

Nancy McCall, a Mathematica researcher who co-authored the 2017 study, said doctors are not the only resistance point. “Patients may not want to be bothered or asked if they are exercising or losing weight or watching their salt intake,” she said.

Still, some physician groups say it’s convenient to outsource the program.

UnityPoint Health, a large integrated health system based in Iowa, tried doing chronic care management on its own, but found it administratively burdensome, said Dawn Welling, the UnityPoint Clinic’s chief nursing officer.

For the past year, it has contracted with a Miami-based company, HealthSnap, to enroll patients, have its nurses make check-in calls each month, and help with billing. HealthSnap helps manage care for over 16,000 of UnityHealth’s Medicare patients — a small fraction of its Medicare patients, which includes those enrolled in Medicare Advantage.

Some doctors were anxious about sharing patient records and viewed the program as a sign they weren’t doing enough for patients, Welling said. But she said the program has been helpful, particularly to many enrollees who are isolated and need help changing their diet and other behaviors to improve health.

“These are patients who call the clinic regularly and have needs, but not always clinical needs,” Welling said.

Samson Magid, CEO of HealthSnap, said more doctors have started participating in the CCM program since Medicare increased pay in 2022 for 20 minutes of work, to $62 from $41, and added billing codes for additional time.

To help ensure patients pick up the phone, caller ID shows HealthSnap calls as coming from their doctor’s office, not from wherever the company’s nurse might be located. The company also hires nurses from different regions so they may speak with dialects similar to those of the patients they work with, Magid said.

He said some enrollees have been in the program for three years and many could stay enrolled for life — which means they can bill patients and Medicare long-term.

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

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.

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.

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.

The Horrors of TMJ: Futile Treatments for Chronic Jaw Pain

By Brett Kelman, KFF Health News, and Anna Werner, CBS News  

A TMJ patient in Maine had six surgeries to replace part or all of the joints of her jaw.

Another woman in California, desperate for relief, used a screwdriver to lengthen her jawbone daily, turning screws that protruded from her neck.

A third in New York had bone from her rib and fat from her belly grafted into her jaw joint, and twice a prosthetic eyeball was surgically inserted into the joint as a placeholder in the months it took to make metal hinges to implant into her jaw.

“I feel like Mr. Potato Head,” said Jenny Feldman, 50, of New York City, whose medical records show she’s had at least 24 TMJ-related surgeries since she was a teenager. “They’re moving ribs into my face, and eyeballs, and I feel like a toy … put together [by] somebody just tinkering around.”

These are some of the horrors of temporomandibular joint disorders, known as TMJ or TMD, which afflict up to 33 million Americans, according to the National Institutes of Health.

Dentists have attempted to heal TMJ patients for close to a century, and yet the disorders remain misunderstood, under-researched, and ineffectively treated, according to an investigation by KFF Health News and CBS News.

JENNY FELDMAN

Dental care for TMJ can do patients more harm than good, and a few fall into a spiral of futile surgeries that may culminate in their jaw joints being replaced with metal hinges, according to medical and dental experts, patients, and their advocates speaking in interviews and video testimony submitted to the FDA.

TMJ disorders cause pain and stiffness in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Dentists have commonly treated the disorder with splints and orthodontics. And yet these treatments are based on “strongly held beliefs” and “inadequate research” — not compelling scientific evidence nor consistent results — according to the National Academies of Sciences, Engineering and Medicine, which reviewed decades of research on the topic. The NIH echoes this message, warning that there is “not a lot of evidence” that splints reduce pain and recommends “staying away” from any treatment that permanently changes the teeth, bite, or jaw.

“I would say that the treatments overall have not been effective, and I can understand why,” said Rena D’Souza, director of the NIH’s National Institute of Dental and Craniofacial Research. “We don’t understand the disease.”

For this investigation, journalists with KFF Health News and CBS News interviewed 10 TMJ patients with severe symptoms who said they felt trapped by an escalating series of treatments that began with splints or dental work and grew into multiple surgeries with diminishing returns and dwindling hope.

In every interview, the patients said the TMJ pain worsened throughout their treatment and they regretted some, if not all, of the care they received.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

TMJ has become an umbrella term for about 30 disorders that afflict roughly 5% to 10% of Americans. Minor symptoms may not require treatment at all, and many cases resolve by themselves over time. Severe symptoms include chronic pain and may limit the ability to eat, sleep, or talk.

In a comprehensive study of TMJ disorders by the national academies, including input from more than 110 patients, experts found that most health care professionals, including dentists, have received “minimal or no training” on TMJ disorders and patients are “often harmed” by “overly aggressive” care and the lack of proven treatments.

The American Dental Association, which represents about 160,000 dentists nationwide and establishes guidelines for the profession, declined an interview request. In a written statement, ADA President Linda Edgar said that TMJ disorders are “often managed rather than cured” and that it sees “great potential” in new efforts to research more treatment options.

Terrie Cowley, a longtime TMJ patient who leads the TMJ Association, an advocacy group that has spoken with tens of thousands of patients, said she was so disillusioned with dental care for TMJ that she advises many patients to avoid treatment entirely, potentially for years.

“Almost 100 years this has been in dentistry, and look at what we have,” Cowley said. “A whole ton of people pretending they know everything, and we don’t know anything.”

‘Not Taken Seriously’

Scientific studies have found that TMJ disorders arise up to nine times as often in women, particularly those in their 20s and 30s, leading to theories that the cause may be linked to reproductive hormones. But a true understanding of TMJ disorders remains elusive.

Kyriacos Athanasiou, a biomedical engineering professor at the University of California-Irvine, said it was because TMJ disorders are more prevalent among women that they were historically dismissed as neither serious nor complex, slowing research into the cause and treatment.

The resulting dearth of knowledge, which is glaring when compared with other joints, has been “a huge disservice” to patients, Athanasiou said. In a 2021 study he co-authored, researchers found that the knee, despite being a much simpler joint, was the subject of about six times as many research papers and grants in a single year than the jaw joint.

D’Souza agreed that TMJ disorders were “not taken seriously” for decades, along with other conditions that predominantly affect women.

“That has been a bias that is really long-standing,” she said. “And it’s certainly affected the progress of research.”

Patients have felt the effect too. In interviews, female patients said they felt patronized or trivialized by male health care providers at some point in their TMJ treatment, if not throughout. Some said they felt blamed for their own pain because they were viewed as too stressed and clenching their jaw too much.

“We desperately need research to find the reasons why more women get TMJ disease,” wrote Lisa Schmidt, a TMJ Association board member, in a 2021 newsletter from the organization. “And surgeons need to stop blaming this condition on women.”

Schmidt, 52, of Poway, California, said she was diagnosed with TMJ disorder in 2000 due to headaches, and an orthodontist immediately recommended her for a splint, braces, and surgery.

After wearing the splint for only three days, Schmidt said, she was in “excruciating pain” and could no longer open her mouth far enough to eat solid food. Schmidt said she spent the next 17 years stuck on a “surgery carousel” with no escape, and eventually was in so much pain she abandoned her career as an aerospace scientist who worked alongside NASA astronauts.

Schmidt said her low point came in 2016. In an attempt to restore bone that had been cut away in prior surgeries, a surgeon implanted long screws into Schmidt’s jaw that protruded downward out of her neck. Schmidt said she was instructed to tighten those screws with a screwdriver daily for about 20 days, lengthening the corners of her jaw to restore the bone that had been lost. It didn’t work, Schmidt said, and she was left in more pain than ever.

“Every time you have a surgery, your pain gets worse,” Schmidt said. “If I could go back in time and go talk to younger Lisa, I would say ‘Run!’”

LISA SCHMIDT AND A 2017 MEDICAL SCAN OF HER FACE

Lack of Sufficient Evidence

Many of the shortcomings of TMJ care were laid bare in the 426-page report published by the national academies in March 2020 that received limited public attention amid the coronavirus pandemic. The report’s 18 authors include medical and dental experts from Harvard, Duke, Clemson, Michigan State, and Johns Hopkins universities.

Sean Mackey, a Stanford professor who co-led the team, said it found that patients were often steered toward costly treatments and “pathways of futility” instead of being taught to manage their pain through strategies and therapies with “good evidence.”

“We learned it’s a quagmire,” Mackey said. “There is a perverse incentive in our society that pays more for things we do to people than [for] talking and listening to people. … Some of those procedures, some of those surgeries, clearly are not helping people.”

Among its many findings, the national academies said it has been widely assumed in the field of dentistry that TMJ disorders are caused by a misaligned bite, so treatments have focused on patients’ teeth and bite for more than 50 years. But there is a “notable absence of sufficient evidence” that a misaligned bite is a cause of TMJ disorders, and the belief traces back to “inadequate research” in the 1960s that has been repeated in “poorly-designed studies” ever since, the report states.

Therefore, TMJ treatment that makes permanent changes to the bite — like installing braces or crowns or grinding teeth down — has “no supporting evidence,” according to the national academies report. The NIH warns that these TMJ treatments “don’t work and may make the problem worse.”

Dental splints, the most common TMJ treatment, also known as night guards or mouth guards, are removable dental appliances that are molded to fit over the teeth and can cost hundreds or even thousands of dollars out-of-pocket, according to the TMJ Association. Like most medical devices, splints generally go through the FDA’s 510(k) clearance process, which does not require each splint to be proven effective before it can be sold, according to the agency.

The national academies’ report states that splints produce “mixed results” for TMJ patients, and even when splints succeed at reducing jaw pain it is not understood why they work. Hundreds of splint designs exist, the report states, and some dentists reject research that challenges the use of splints unless it focuses on the specific design they prefer.

“Because of the hundreds of variations in [splint] design, it is unlikely that any study could ever be conducted that will be considered sufficient to a particular dentist with a pre-existing belief about the effectiveness of one appliance,” the report states.

Other treatments fare no better. The FDA has not labeled any drugs specifically for TMJ disorders, and pain medicines can be too weak or addictive to be a long-term solution, according to the TMJ Association. Botox injections may ease pain but have raised concerns about bone loss during animal testing. The NIH warns that minor surgeries that flush the jaw with liquid bring only temporary pain relief and that more complex surgeries should be reserved for severe cases because they have yet to be proved safe or effective in the long term.

To improve care, the national academies called for better education about TMJ disorders across medicine and dentistry and more research funding from the NIH, which has a “ripple effect” on research and training across the nation.

Since the 2020 report, the NIH has launched a TMJ research collaborative and increased annual research funding from about $15 million to about $34 million, D’Souza said. TMJ care was added to the standards that dental schools must teach to be accredited in 2022. The national academies launched an ongoing forum on TMJ disorders last year.

But TMJ funding still pales in comparison to other ailments. The NIH spends billions each year to research deadly diseases, like cancer and heart disease, that also afflict large numbers of Americans. It spends millions more on research of non-life-threatening conditions like arthritis, back pain, eczema, and headaches.

Mackey noted that much of the NIH’s spending is allocated by Congress.

“If Congress comes in and says, ‘We want to devote X amount of money to [TMJ],’ all of the sudden you will see an increase in money,” Mackey said. “So that’s my message to people out there: Raise your voices. Write your legislator.”

Total Jaw Replacement

Plagued by TMJ symptoms, and after failed treatments, some patients turn to a last resort: replacing their jaw joint with synthetic implants. Surgeons might replace the cartilage disk at the core of the joint or use “total joint replacement surgery” to fasten a metal hinge to the bones of the skull.

But the implants have a harrowing history: Several disk implants were recalled or discontinued in the ’90s due to dangerous failures. The FDA now classifies TMJ implants among its most closely monitored medical devices because the products on the market today can cause “adverse health consequences” if the devices fail, according to the agency’s website.

JENNY FELDMAN HAD 2 TOTAL JAW REPLACEMENTS

Two companies, Zimmer Biomet and Stryker, make the only total jaw replacement implants currently sold in the U.S.

Zimmer Biomet, which has made its implant for more than two decades, described it in email statements as “a safe and efficacious solution” for patients who need their jaw joint replaced, either due to TMJ disorders, failed surgeries, injuries, or other ailments. An FDA-mandated study completed in 2017 found about 14% of patients who get the Zimmer Biomet implant require additional surgery or removal within 10 years, said agency spokesperson Carly Pflaum.

Stryker, which in 2021 bought a company that made a total jaw replacement implant and now makes the implant itself, declined to comment. Although the NIH has advised TMJ patients to avoid surgery since at least 2022, Stryker launched a “patient-facing website” for the implant last year and is recruiting surgeons to be added to a “surgeon locator” feature on the site, according to posts on Facebook and LinkedIn.

A study of the Stryker implant’s success rate was mandated by the FDA and completed in 2020, but the agency has yet to make the results public.

D’Souza, the NIH official, said that based on her professional experience, she estimates that most total jaw replacement surgeries are ultimately ineffective.

“The success rate is low,” D’Souza said. “It is not very encouraging.”

Multiple patients provided KFF Health News and CBS News with medical records showing their total jaw replacement implants had to be removed due to malfunction, infection, or previously unknown metal allergies. Several patients said that since their implants were removed months or years ago, they have lived with no hinge in their jaw at all.

Kalinowski, the TMJ patient in Maine, has had portions of her jaw joint replaced six times, including receiving four implants. Her medical records show that the cartilage disk on her right side was replaced in 1986 with an implant that was later recalled and again in 1987 with another that was later discontinued. Her left and right disks were replaced in 1992 with a muscle flap and rib graft, respectively, and her entire right joint was replaced with yet another implant that was later discontinued in 1998. Both joints were replaced again in 2015, her records show.

Since then, Kalinowski said, her artificial jaw has functioned properly, although she remains in pain and cannot move her jaw from side to side. Her mouth hangs open when her face is at rest, and she drinks protein shakes for lunch because it’s easier than struggling with solid food.

But the “worst part,” Kalinowski said, is that her surgeries caused nerve damage on her lower face, and so she has not felt her husband’s kisses since the ’90s.

“If there was one moment in my life I could take back and do over again, it would be that first surgery. Because it set me on a trajectory,” Kalinowski said. “And it never goes away.”

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

Physical Activity Can Protect Against Chronic Pain

By Pat Anson, PNN Editor

Chronic pain sufferers are often told that physical activity and exercise can help reduce pain and improve quality of life. Now there is evidence that even light or moderate activity can have a protective effect against pain that lasts for years.

“We found that people who were more active in their free time had a lower chance of having various types of chronic pain 7-8 years later,” says Anders Årnes, a doctoral fellow at The Arctic University of Norway and University Hospital of North Norway.

“This suggests that physical activity increases our ability to tolerate pain and may be one of the ways in which activity helps to reduce the risk of developing severe chronic pain.”

Årnes is the lead author of a study, recently published in the journal PAIN, that found even light physical activity was associated with a 5% lower risk of developing chronic pain that lasts at least three months. More rigorous activity was associated with a 16% reduced risk of widespread moderate-to-severe chronic pain.

The findings are based on data from a large health survey -- the Tromsø Study --- in which over 6,800 Norwegians answered questions about their overall health, pain levels and physical activity, first in 2007-2008 and then again in 2015-2016. The average age of participants was nearly 55. Most reported some form of chronic pain, but only 5% had widespread moderate-to-severe chronic pain.

In a 2023 analysis of the survey data, Årnes and his colleagues found that people who reported vigorous physical activity had significantly more pain tolerance than those with a sedentary lifestyle.

Pain tolerance was assessed by how long they could keep a hand immersed in cold water that was a few degrees above freezing (3 degrees Celsius or 37.4 degrees Fahrenheit).

In their new follow-up study, researchers found that the ability to tolerate pain – or at least cold water -- plays a modest role in the protective effect of physical activity (PA).  

Stina Grønbech/Tromsøundersøkelsen

“We estimate that higher PA levels predict lower risk of chronic pain, with indications of a small mediated effect on this risk through cold pain tolerance for moderate-to-severe chronic pain states,” researchers reported.

Of course, many people with severe chronic pain are unable to exercise or fear that it will only make their pain worse. Previous studies have found that low-impact exercise programs, such as stretching while sitting in a chair, can ease pain from arthritis and other muscle and joint conditions.

“Physical activity is not dangerous in the first place, but people with chronic pain can benefit greatly from having an exercise program adapted to help them balance their effort so that it is not too much or too little,” said Årnes. “A rule of thumb is that there should be no worsening that persists over an extended period of time, but that certain reactions in the time after training can be expected.”

Even moderate physical activity can stimulate the production of endorphins and endocannabinoids – hormones and lipids naturally produced by the body -- which can relieve pain and inflammation. Regular exercise can also help us lose weight, reduce the risk of heart disease, and boost overall health.