FDA Approves Device That Uses Artificial Intelligence to Treat Chronic Pain

By Pat Anson, PNN Editor

The Nevro Corporation says it has won approval from the Food and Drug Administration for an advanced spinal cord stimulator (SCS) that uses artificial intelligence to individualize treatment for each patient.

Nevro says its Senza HFX iQ stimulator “learns from patients” as they use the device and develops customized algorithms for treating chronic back pain, leg pain and pain from diabetic neuropathy.

"HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care," D. Keith Grossman, Chair and CEO of Nevro, said in news release.

"Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world.  HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.”

Nevro says patients will start with a program most likely to provide pain relief, and then adjusts it over time based on patient input and medical data, such as pain scores, activity levels and changes in use of pain medication. Patients can also adjust their pain relief programs through an app on their smartphones.

Spinal cord stimulators are usually considered the treatment of last resort for people with intractable or severe chronic pain that doesn’t respond to other therapies. The surgically implanted devices emit low levels of electricity that reduce the intensity of pain signals.

Unlike older stimulators, Senza stimulators use electric pulses of 10 kHz, a high frequency that doesn’t create an uncomfortable tingling sensation and delivers more pain relief. Last year the FDA approved Senza stimulators for the treatment of painful diabetic neuropathy, making it the first spinal cord stimulation system approved for that condition. Until then, most SCS devices were only approved for patients with severe back pain.

About 50,000 stimulators are implanted in the U.S. every year, with failure rates for the devices estimated at 25 to 30 percent. Most patients are required to undergo psychological testing and a trial treatment before getting a SCS.

The FDA has come under scrutiny for its regulation of stimulators and other medical devices.  A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths.  The agency responded to the report by sending a letter to healthcare providers reminding them to only implant stimulators after a trial period that demonstrates the device are effective. An FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Nevro says it will begin a limited release of Senza HFX iQ later this year, with a full market launch in the U.S. in early 2023. Nevro is also seeking approval of HFX iQ in Europe.  

Time to Reject the Label ‘Failed Back Surgery Syndrome’

Dr. Forest Tennant, PNN Columnist

In our research studies on Adhesive Arachnoiditis (AA), a high percentage of patients tell us that their doctors have said the cause of their pain is “Failed Back Surgery Syndrome” (FBSS).

This misnomer and poor excuse for a diagnosis has fortunately been rejected “out-of-hand” as a cause of pain by most upscale physicians. After all, FBSS is neither a disease nor a symptom. We can do better in 2022.

Some three or four decades ago, FBSS became a popular moniker used by most physicians, including this author. Why? Patients who had back pain underwent surgery, which was technically and expertly done, but the pain didn’t go away. This situation was a mystery in times past, but the label FBSS should never be used or applied in this day and age.

Today, magnetic resonance imaging (MRI) has advanced so much since its invention in the late 1980’s that painful disorders and diseases of the spine can almost always be diagnosed. There is now a technique called “contrast MRI” that allows a clear distinction to be made between spinal fluid and solid tissues, including the spinal cord, discs, nerve roots and covering of the spinal canal.

In our recent research studies, we have reviewed contrast MRIs in well over 200 persons who have been labeled as having FBSS. Every person had one or more obvious reasons to have chronic pain, despite well-done, competent surgery. For example, our reviews have found discs that have protruded, adhesive arachnoiditis, epidural fibrosis, spondylolisthesis, Tarlov Cysts, arthritic vertebra or other good, solid reasons to have pain, regardless of surgery.

Let’s be clear. Spine surgery may be necessary for a number of reasons, the most common being significant herniation of a disc or collapse of vertebrae that may dangerously compress the spinal canal. It also may be fair to say that a lot of surgery can now be avoided, since eminent danger and need for surgery is pretty clear cut on modern, contrast MRI’s.    

In addition to contrast MRIs, we now have good diagnostic tests for inflammation, autoimmunity and genetic connective tissue disorders, which are emerging as legitimate causes of severe, chronic back pain that hasn’t responded to chiropractic, physical therapy, anti-inflammatory agents and corticosteroid injections.

Put simply, the diagnostic evaluation of severe chronic back pain needs a contrast MRI and specific diagnostic tests rather than a non-descript, “wastebasket” diagnosis like FBSS.

Perhaps the worst thing about the label FBSS, is that it is easy to apply and avoids the time, money and knowledge to make a specific diagnosis. These excuses to avoid a specific diagnosis must now be rejected because we have the diagnostic and treatment measures to better the lives and health of those who suffer from severe chronic back pain.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis through the Tennant Foundation’s Arachnoiditis Research and Education Project and the Intractable Pain Syndrome Research and Education Project.

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

Over 72 Million Americans Suffer Chronic Low Back Pain

By Pat Anson, PNN Editor

Nearly 3 out of 10 U.S. adults – 72.3 million people – currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease, according to a large new Harris Poll. Over a third of those surveyed (36%) rate their back pain as “severe” or the “worst pain possible” and nearly half (44%) said they’ve experienced back pain for at least five years.

Over 5,000 adults participated in the online survey, which was sponsored by Vertos Medical, a company that makes medical devices to treat lumbar spinal stenosis (LSS).

One of the major findings in the survey is that over a third (37%) of adults with chronic low back pain (CLBP) have never been told by a healthcare professional what causes their pain. The vast majority (84%) say they wish there were better treatment options for CLBP.

"These survey results demonstrate that people with chronic low back pain are suffering greatly over long periods of time, and many have resigned themselves to living in a debilitated state," Kathy Steinberg, Vice President of Media and Communications Research at The Harris Poll, said in a statement. "The fact that more than a third are not being told what is causing their pain, such as LSS or an enlarged ligament, makes it more difficult to treat that pain.”

Lower back pain is the leading cause of disability, affecting about 540 million people worldwide. With so many people suffering, you'd think there would be a consensus on the best way to treat CLBP. But a 2018 review by The Lancet found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers -- often against treatment guidelines.

The Harris Poll found that many Americans with CLBP are being treated with ineffective therapies, resulting in multiple visits to multiple doctors. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with an average of 4 office visits in the last year.  

Over one in five (21%) have had epidural steroid injections (ESIs), with 37% having 5 or more injections. ESI’s are not FDA-approved and the agency has warned that injections into the epidural space can result in rare but serious neurological problems, including loss of vision, stroke and paralysis. ESI’s were rated as one of the least effective treatments for CLBP in the Harris Poll.

Nearly a third of those surveyed (30%) said they have been prescribed opioids and 15% said they are currently taking them, even though medical guidelines caution that opioids are not appropriate for CLBP.

Opioids may not be recommended, but nearly 8 out of 10 (79%) said the medications were very or somewhat effective, making opioids the highest rated treatment for CLBP, slightly ahead of “conservative or eastern medicine” treatments such as physical therapy, chiropractic care and acupuncture.

Source: The Harris Poll

About half of those surveyed say CLBP has a major or moderate impact on their quality of life (53%), physical health (50%) and mental health (39%). Most strongly agree or somewhat agree (78%) that they have accepted CLBP as a part of their life.  

For more information about treatment options for CLBP, visit Know Your Back Story, a website hosted by Vertos Medical that promotes treatments for lumbar spinal stenosis.

Physical Therapy Reduces Healthcare Costs for Low Back Pain

By Pat Anson, PNN Editor

Almost everyone suffers from low back pain at some point in their lives. Most recover in a few days, but for some the pain lingers and become chronic, making low back pain the world’s leading cause of disability.  

Why are some people able to recover quickly from low back pain?

For many, the answer may be early treatment with physical therapy (PT), according to a new study by researchers at Johns Hopkins Medicine.   

“Our goal was to determine if early PT for patients with lower back pain had an impact on their overall health care resource utilization,” says senior author Richard Skolasky Jr., ScD, director of the Johns Hopkins Spine Outcomes Research Center. “We were especially curious about the 30 days after initial symptom onset, as this is when patients are most likely to seek care.” 

Skolasky and his colleagues analyzed healthcare data from 2010 to 2014 for nearly a million U.S. adults with acute low back pain, excluding those suffering from serious disorders such as arthritis or spinal cord injuries. About 10% of the patients received early treatment with physical therapy.

The study findings, recently published by BMC Health Services Research, showed that patients getting early PT were significantly less likely to see a chiropractor, orthopedic surgeon or pain specialist after 30 days than those who did not get physical therapy. They were also less likely to get advanced imaging, epidural steroid injections or to visit an emergency room.

Researchers estimate that healthcare costs for a typical patient getting early PT was about $500 less over 30 days than those not receiving physical therapy.

Another key finding from the study was significant geographical differences in the use of physical therapy. Patients in the West (16%) and Northeast (15%) were nearly twice as likely to get early PT than those in the Midwest (9.4%) and South (8.6%). The authors offered no explanation for why treatment patterns varied so much by region.

The study did not specifically examine whether physical therapy benefits patients with low back pain more than other forms of treatment, but the findings suggest that they did. Researchers say health outcomes should be examined more closely in future studies.

“As the U.S. population ages, the prevalence of lower back pain is expected to increase, along with the associated costs of treating it,” says Skolasky. “Furthermore, with advances in imaging and treatments, the cost of managing lower back pain has increased substantially. Our findings have important implications that may guide health care policy when examining downstream health care costs and resource utilization.” 

Previous studies have found that physical therapy and regular exercise significantly reduces low back pain. Other studies also found little evidence to support the use of opioids, spinal injections and acetaminophen for low back pain.  

Electromedical Treatments for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist  

Adhesive Arachnoiditis (AA) is an inflammatory, nerve root entrapment disease in which cauda equina nerve roots are glued by adhesions to the arachnoid-dural covering of the spinal canal. An inflamed tumor-like mass is formed inside the spinal canal that blocks spinal fluid flow, allows seepage of fluid into tissue outside the spinal canal and shuts off electrical impulses that activate the legs, feet, bladder, intestine and sex organs. Autoimmunity is produced and/or magnified by AA. 

We highly recommend a three-component protocol for AA to reduce inflammation and autoimmunity, regenerate damaged tissue and to provide pain control. Recent advances in electromedical therapies can help achieve these three goals. 

There are two basic types of electromedical devices available for AA treatment: electric current therapy (EC) and electromagnetic therapy (EM). 

Electric Current Therapy 

Almost everyone is familiar with “TENS” units, which stands for “transcutaneous electrical nerve stimulation.” These devices were the first electromedical therapies to relieve pain and promote healing.

TENS units deliver a single electric current into tissues to produce an anesthetic, pain relieving effect.  

Today, more advanced EC devices administer micro-currents and/or a combination of multiple currents with different frequencies. 

Electromagnetic Therapy 

There is a form of energy that is half electricity and half magnetism, which can be divided into wave lengths. The very shortest wave of electromagnetic energy is “atomic” and the longest is “radio.” The shortest wave used in medicine is “laser.” Other electromagnetic energy waves used for medical purposes include infrared, light and microwave. 

EC and EM devices, when placed over the lower back, deliver electric current or electromagnetic energy to the lumbar-sacral spinal canal and the spine’s surrounding tissue.

Modern devices use intermittent pulsation of electric currents or electromagnetic energy to penetrate the skin and subcutaneous tissue to reach the AA site, which is usually about 2-3 inches below the skin.  

Some devices use the label PEMF, which stands for “pulsed electromagnetic frequency.” We believe that the newer EC and EM devices can deliver electric currents or electromagnetic energy that, when pulsed, penetrate deep enough to reach the AA disease site. 

Although not totally curative, these devices usually bring about pain reduction in the 20 to 30% range. Within an individual’s financial capability, we recommend that an EC and/or EM device be used 2 to 3 times a week (not daily). EC and EM therapy are not substitutes for a medical protocol. 

EM and EC devices often produce some initial healing, but later seem to stop working. In this situation the device may have done its maximal healing. The devices can still be used periodically to prevent relapses and treat flares. 

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

Dr. Tennant’s new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is available on Amazon. 

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

Injectable Gel Shows Promise as Treatment for Back Pain

By Pat Anson, PNN Editor

An experimental gel shows promise as a treatment for low back pain caused by degenerative disc disease (DDD), according to the results of a small study being presented at the annual meeting of the Society of Interventional Radiology in Boston.

Hydrogels have been used for years to treat DDD, but this is the first time that Hydrafil – an injectable gel developed by ReGelTec – has been tested on humans.

Hydrafil was injected into the discs of 20 people in Colombia with chronic DDD, who had average pain levels of 7.1 on a 10-point pain scale. None of the participants had found more than temporary, mild relief from treatments such as rest, analgesics, physical therapy and back braces.

“We really have no good treatments for degenerative disc disease, aside from conservative care,” said lead investigator Douglas Beall, MD, a medical advisor to ReGelTec and chief of radiology services at Clinical Radiology of Oklahoma.

“Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is appropriate for only a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can pop out of place if you’re not highly skilled in placing it.”

Because Hydrafil is injectable, it requires no incision and is minimally invasive, although patients are sedated for the procedure. Researchers heat the gel to become a thick liquid and then use a 17-gauge needle to inject it directly into the affected discs, using fluoroscopic imaging to guide them. The gel fills in cracks and tears in the disc, and then hardens, restoring the disc’s structural integrity. The procedure takes about 30 minutes.

This promotional video by ReGelTec demonstrates how Hydrafil works:

Six months after the injection, all 20 participants in the study reported significantly less low back pain, with their pain levels declining to an average of 2.0 on the 10-point pain scale. They also reported significantly better physical function.

“If these findings are confirmed in further research, this procedure may be a very promising treatment for chronic low back pain in those who’ve found insufficient relief from conservative care,” said Beall. “The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.”

In 2020, Hydrafil received the FDA’s breakthrough device designation, which allows for an expedited review of an experimental product when there is evidence it provides more effective treatment than current options.

ReGelTec is currently recruiting 50 people with DDD in Canada for a new clinical trial of Hydrafil.

Degenerative disc disease is one of the leading causes of chronic low back pain. Healthy discs cushion the spine’s vertebrae, facilitating movement and flexibility. But with activity and normal aging, discs can wear out and cause the bones of the spine to rub together and pinch nerves, causing pain and numbness. By age 60, most people have at least some disc degeneration in their spines.

Patient in Tulsa Hospital Shooting Was Angry About Pain Care

By Pat Anson, PNN Editor

The gunman who killed four people Wednesday at an Oklahoma hospital recently had back surgery and was angry about his post-operative pain not being treated, according to police and media reports.

Michael Louis shot and killed Dr. Preston Phillips, the surgeon who performed the operation, as well as another doctor, a medical receptionist and a bystander who took his wife to an appointment at Saint Francis Hospital in Tulsa. The 45-year-old Louis fatally shot himself as police closed in.

“What we currently know is that Louis was in pain, Louis expressed that he was in pain and was not getting relief and that was the circumstance surrounding this entire incident,” said Tulsa Police Chief Wendell Franklin. “He blamed Dr. Phillips for the ongoing pain that came from the surgery.”

Phillips was an orthopedic surgeon who specialized in spinal surgery and joint reconstruction. He graduated from Harvard Medical School in 1990.

No details have been released on what type of back surgery Louis had or what kind of pain medication he was given. According to a niece, he suffered from back pain for “a long time.”

“We are aware that he has been experiencing back pain for a long time but [there is] no reason for this senseless act,” the niece told The Daily Beast. “We are a Christian-based family. We have never experienced this before.”

Police say Phillips operated on Louis on May 19. Louis was released from the hospital on May 24, but called “several times over several days complaining of pain and wanted additional treatment,” according to Franklin. Louis had an appointment with Phillips on Tuesday, the day before the shooting, but it’s not clear if any further pain relief was offered to him.

In the days following his surgery, Louis was living in the home of his ex-wife, Dr. Edith Lubin, a family practice physician. Her lawyer released a statement saying Lubin had no knowledge of her former husband possessing a gun or having “any intent of harming anyone.”

“Dr. Lubin is praying for the families of all those affected. She acknowledges everyone’s concerns in understanding what happened, but she is at a loss for an explanation, other than the effect of continuing pain to Mr. Louis during his recovery,” the lawyer said in a statement to a KJRH-TV reporter.

Louis bought a handgun on Sunday and a semiautomatic rifle on Wednesday afternoon, just hours before the shooting. Both weapons were legally purchased, according to police.

Franklin said a letter found on Louis after the shooting “made it clear that he came in with the intent of killing Dr. Phillips and anyone who got in his way.”

Asked whether opioids were involved in Louis’ treatment, Franklin said investigators have only established that he was in pain and that other details about his care were still being investigated, according to The Washington Post.

‘Just a Matter of Time’

In recent years, many U.S. hospitals have stopped or reduced the use of opioids after surgery, fearing patients may become addicted. Non-opioid analgesics and over-the-counter pain relievers such as Tylenol are increasingly being used to treat post-operative pain.

"Out of all the hospital systems in Oklahoma, I have heard the most about the horrible pain treatment at St. Francis,” said Tamera Lynn Stewart, an Oklahoma patient advocate and Policy Director for the P3 Political Action Alliance. “I know so many who have had surgery there and received Tylenol only or who see doctors there that claim they aren’t allowed to prescribe." 

Opioid addiction is actually rare after surgery. Studies have found that less than 1% of patients are still taking opioids a year after major surgery or were later diagnosed with opioid dependence.  

With their pain poorly treated or left untreated, Stewart says some desperate patients in Oklahoma have threatened to kill themselves on the steps of the state capitol to make a statement. The mass shooting at the Tulsa hospital, while tragic, was not unexpected to her. 

“While our hearts are grieving with the families and victims, few in our grassroots communities built to advocate for appropriate treatment of pain without government or third-party interference can say this was completely unexpected. Veterans have committed suicide at VA’s across the country for the same reason,” Stewart told PNN. 

“Most of us knew it was just a matter of time before someone who could no longer bear the unrelenting pain did something more drastic in order to get the attention needed to end the restrictions (on opioids) and begin the much-needed process of swinging the pendulum back to a more neutral position.” 

Long before Tulsa, there were other cases where people in pain resorted to drastic action. In 2017, a man suffering from chronic back pain shot and wounded two people at a Las Vegas pain clinic before taking his own life.   

That same year, an Indiana doctor was fatally shot by a man who was upset because the physician refused to prescribe opioids to his wife, who suffered from chronic pain.

Virtual Reality Shows Long Term Benefits for Chronic Low Back Pain

By Pat Anson, PNN Editor

Critics of virtual reality therapy often say it’s a poor treatment for chronic pain because it only distracts patients from their pain and that the effects are temporary, at best.

But new research suggests that the benefits of virtual reality (VR) can last six months after treatment has stopped – at least for patients with chronic low back pain.

The study, published in the Journal of Medical Internet Research, followed 188 people with chronic low back pain who had an average pain intensity score of 5 on a zero to 10 point scale.

Half the participants were given an EaseVRx headset to watch 3-D programs daily for 8 weeks, immersing themselves in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is help patients learn how to manage pain through cognitive behavioral therapy.  

The other patients also used the EaseVRx headset, but only watched routine nature scenes as a placebo or sham VR treatment.  

JOURNAL OF MEDICAL INTERNET RESEARCH

Patients were followed for six months after treatment was stopped. Participants in both groups reported improvement in their pain and other symptoms six months after treatment, but the improvements were more significant in those who received VR therapy. Pain intensity was 31% lower for patients in the VR group, compared to 16% in the sham group. Physical function, mood, sleep and pain-related interference in activity were also better in those who received VR therapy. No adverse side effects were reported in either group.

“We have been pleasantly pleased and surprised that patients are maintaining clinically meaningful changes in pain intensity and interference 6 months after returning the device. It appears people are actually acquiring skills in a relatively short period that they continue to retain/apply months after treatment,” said Josh Sackman, co-founder and president of AppliedVR, which makes the EaseVRx headset.

AppliedVR is planning more research to see how patients respond long-term to VR treatment. A brain imaging study is being conducted to measure brain activity before, during and after treatment. Patients are also being recruited for a large clinical trial to see how VR therapy impacts pharmacy and medical claims.  

“In order to drive real acceptance, we are committed to extensive research to address any skepticism people may have,” Sackman told PNN.

The EaseVRx headset was given a Breakthrough Device Designation by the FDA in 2020 for fibromyalgia and low back pain. Last year the agency authorized the marketing of the headset for chronic low back pain in adults, the first medical device of its kind to receive that designation.

EaseVRx headsets are currently being used for pain management in over 200 hospitals and healthcare systems. A full commercial launch for home-based use is not expected until next year.

100,000 ‘Unnecessary’ Hospital Procedures Performed in First Year of Pandemic

By Pat Anson, PNN Editor

U.S. hospitals performed over 100,000 “low-value” procedures on Medicare patients in the first year of the Covid pandemic, including tens of thousands of spinal surgeries and knee arthroscopies, according to a recent study by the Lown Institute, a non-profit that seeks to reduce the use of unnecessary and ineffective medical treatments.

In 2020, no vaccines were available, the elderly were particularly vulnerable to the Covid-19 virus, and intensive care units were filled with infected patients. Yet many hospitals continued to perform questionable elective procedures at the same rate they did in 2019.

“You couldn’t go into your local coffee shop, but hospitals brought people in for all kinds of unnecessary procedures,” Vikas Saini, MD, president of the Lown Institute, said in a statement. “The fact that a pandemic barely slowed things down shows just how deeply entrenched overuse is in American healthcare.”

Lown researchers analyzed Medicare claims from U.S. hospitals for eight procedures that the non-profit considers to have “little to no clinical benefit” and are potentially harmful.  

Coronary stents were the most overused procedure, with over 45,000 balloon angioplasties performed to open up blocked arteries. The Lown Institute has long maintained that stents are unnecessary and risky in patients with stable heart disease.

Two spinal surgeries also made the list: 13,541 spinal fusions and 16,553 vertebroplasties were performed on older patients. In vertebroplasty, bone cement is injected into fractured vertebrae to stabilize the spine; while spinal fusions are used to join two or more vertebrae together to prevent them from moving and causing more pain. The Lown Institute considers fusions and vertebroplasties inappropriate for patients with low back pain and osteoporosis.

Nearly 1,600 knee arthroscopies were also performed in 2020, a type of “keyhole” surgery in which a small incision is made in the knee to diagnose and repair ligaments damaged by overuse or osteoarthritis. Recent independent studies have found arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long term.

“There are certain things, certain practices that are just insane. You shouldn’t be doing this. Nobody should pay for this,” said Saini.

Highland Hospital in Rochester, New York was rated as the top hospital in the country for avoiding overuse procedures. Richardson Medical Center in Rayville, Louisiana was ranked as the worst hospital.

The American Hospital Association disputed Lown's ranking system, calling it misleading.

"Throughout the pandemic, but especially in the early months, many nonessential services and procedures were put off due to government restrictions or voluntary actions from hospitals to make room for massive surges of COVID-19 patients," Aaron Wesolowski, AHA's VP of policy research, said in a statement to Becker’s Hospital Review.

"Studies have shown that these delays or sometimes even cancelations in nonemergent care have had some negative outcomes on the health and well-being of patients, who continue to show up at the hospital sicker and with more advanced illnesses. Many of these services may alleviate patients' pain or provide other help to patients. Lown may define these services as 'low value,' but they can be of tremendous value to the patients who receive them."

Emergency Treatment of Arachnoiditis After Spinal Injection

By Dr. Forest Tennant, PNN Columnist

In rare cases, symptoms suggesting adhesive arachnoiditis (AA) may occur after a spinal tap or epidural injection (therapeutic or obstetrical). These early symptoms may include localized lumbar pain, headaches, burning sensations, dizziness, leg weakness and bladder dysfunction. Spinal fluid leaks or blood in the spinal canal are often suspected in these cases.  

If symptoms indicate the possibility that AA may be developing, we recommend emergency treatment to hopefully prevent the spinal nerve inflammation from spreading and becoming chronic. 

A problem that we have routinely discovered is that medical practitioners commonly have the false belief that they can see signs of AA on an MRI when symptoms begin or within a few hours or days after a spinal tap or epidural injection. But AA typically does not show on an MRI for at least four to six weeks. Consequently, early emergency treatment must be based on patient history and symptoms, rather than on MRI findings. 

At the First International Congress on Arachnoiditis and Tarlov Cysts in 2010, physicians Donna Holder and Antonio Aldrete recommended that methylprednisolone 500 mg be given intravenously every day for five days as an emergency treatment for AA.  

Since that time, a variety of intravenous methylprednisolone attempts with different dosages and frequency have been used by physicians as emergency treatment to prevent AA. Dr. Aldrete opined that intravenous methylprednisolone is only effective in preventing AA if given within 60 days after the spinal tap or epidural. 

We have used the following alternative treatments to intravenous methylprednisolone: 

  1. Medrol (methylprednisolone) six-day oral dose pack

  2. Ketorolac 30 to 60 mg injection for three consecutive days

  3. Medroxyprogesterone 10 mg given twice a day for six days

In some, but not all cases, AA symptoms will abate during the week that either intravenous methylprednisolone or the alternative treatments are administered. In most cases, however, symptoms reduce but don’t totally abate. The reason for this is unclear, but a reasonable assumption is that spinal canal inflammation may not be totally reversed once symptoms begin. 

If pain and other symptoms don’t totally abate, we recommend that the patient begin a three-component medical protocol for AA described in this bulletin, which includes nutritional, physiologic and pharmacologic elements. Patients should remain on these medical treatments until and if their pain and other symptoms resolve. 

It is unclear why only a small percentage of persons who have spinal taps or epidural injections develop AA. It is also unknown why symptoms that begin after these procedures usually don’t abate. 

A New Handbook for Practitioners

Our new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is now available on Amazon. 

This handbook for medical practitioners has been written for one simple reason.  AA is no longer a rare disease.  We conservatively estimate that there are at least 1.75 to 2.75 million adults in the U.S. who have AA.  

In the past, the cause of their back pain was often listed as unknown or inappropriately labeled as failed back syndrome, degenerative spine or simply low back pain. 

It is our fervent hope that this book will help medical practitioners and their patients diagnose and treat this most debilitating disease.

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

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

High-Frequency Spinal Cord Stimulators Provide More Pain Relief

By Pat Anson, PNN Editor

Spinal cord stimulators are often considered the treatment of last resort for patients with intractable or severe chronic pain. The surgically implanted devices emit low levels of electricity that reduce pain signals, but have high failure rates and often have to be removed because they’re ineffective, cause infections or need new batteries.

Two new studies suggest there are ways to improve the success rate of spinal cord stimulators (SCS) through improved patient selection and the use of high-frequency devices.

Low-frequency SCS (50 Hz) was first approved by the Food and Drug Administration for intractable back and leg pain in 1989. Six years later, the FDA approved high-frequency devices (10,000 Hz), that deliver pulses of electrical stimulation that are shorter in duration, lower in amplitude and do not cause paresthesia, an irritating sensation of tingling or prickling.

In a retrospective study of 237 patients who received stimulators between 2004 and 2020, researchers at the University of California San Diego School of Medicine reported that high-frequency devices were more effective at reducing pain and opioid use than low-frequency ones.

The study findings, published in the journal Bioelectronic Medicine, also show that male patients benefit more than women from high-frequency neuromodulation.

"Our work was sparked by a growing literature that demonstrate sex specific immune pathways differentially contribute to chronic pain processes," said senior author Imanuel Lerman, MD, an associate professor of anesthesiology at UC San Diego Health. "The observed parameter-specific (high versus low frequency) sex-based differences in spinal cord stimulation efficacy and opiate use are definitely intriguing.”

It’s not clear why men benefit more than women, but researchers believe it may be due to the male hormone testosterone having a modulating effect on pain signals. The sex differences may also be due to males and females processing chronic pain differently.

"Clearly more work needs to be done to carefully characterize sex specific pain regulatory pathways that may prove responsive to specific types of neuromodulation and or pharmaceutical therapies," said Lerman.

Improved Patient Selection  

Although most patients are required to undergo psychological testing and a trial treatment before getting a SCS, failure rates for the devices remain high at around 25 to 30 percent. With about 50,000 stimulators implanted in the U.S. every year, that means thousands of patients are getting poor results.

To improve patient outcomes, researchers at Florida Atlantic University developed machine-learning algorithms to help predict which patients may benefit from SCS. Working with a cohort of 151 SCS patients, they evaluated 31 features or characteristics in each patient.  

Researchers found two distinct clusters of patients which differ significantly in age, duration of chronic pain, preoperative pain levels and pain catastrophizing scores. They used computers to fine-tune the results, identifying the 10 most influential features that contribute the most to a successful SCS implant.

Results of the study, published in the journal Neurosurgery, demonstrate for the first time the ability of machine-learning algorithms to predict long-term patient response to SCS placement. The next step is to validate the data in future patients to ensure that the algorithm is useful in real-world situations, not just computer models.

"Our study resulted in the development of a model to predict which patients would benefit from spinal cord stimulation," said lead author Julie Pilitsis, MD, dean and vice president of medical affairs at Florida Atlantic University's Schmidt College of Medicine.  "After we validate this work, our hope is that this machine-learning model can inform a clinical decision support tool to help physicians better choose which patients may be most appropriate."

SCS is no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of SCS to include lower limb pain from diabetic neuropathy.  Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A decision to get a SCS shouldn’t be taken lightly. A 2018 study by a team of investigative journalists found that stimulators have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving SCS found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

Sacroiliac Joints: An Overlooked Cause of Back Pain

By Victoria Reed, PNN Columnist

I’ve suffered from low back pain for a long time, beginning in my 20’s. I would have terrible spasms, pain, stiffness and leg numbness, which left me unable to walk or function at all.

I went through the usual testing to determine the cause and was asked if I had had some kind of accident or injury. The answer was always no. The only thing I could think of that may have contributed to the back pain was the fact that I ran track throughout my elementary and high school years. I figured all that running might have taken a toll on my spine.

An MRI revealed a bulging disk at the lumbar level. I was offered a nerve block, which helped relieve the pain for a while. But when I had children, the pain returned -- probably because the strain and added weight from pregnancy put extra pressure on my spine. 

A doctor offered a series of epidural spinal injections in which a steroid would be injected to try and shrink the bulging disk. The first shot didn’t work at all, but I was encouraged to try another one. The second didn’t work either. I was then put on pain and nerve medications, which did help somewhat.

Because I was using a prescription opioid, I had to go back periodically for regular exams to see if the meds were helping and still necessary. During one of those routine exams, the doctor asked me to point specifically to where the pain was coming from. I had been doing my own research online and thought the majority of the pain wasn’t coming from the bulging disk, but from my sacroiliac (SI) joints.

The SI joints are made up of the sacrum and the ilium of your pelvis, and are located on the right and left sides of your lower back. They are held in place by strong ligaments. Rheumatoid arthritis (RA) might increase the risk of having trouble with these joints. Though it’s commonly said that RA primarily affects the hands and feet, any joint can be affected.

I mentioned that to my doctor, but he wanted me to have more epidural steroid injections. I refused, partly because they didn’t help before and partly because I’m diabetic, and high-dose steroids cause the blood sugar to go up.

From there, I was sent to physical therapy. The therapy sessions were centered around strengthening my core abdominal muscles, and they did help reduce the number of times my back went out. However, the SI joint pain was still consistently there. During subsequent doctor appointments, and finally after some convincing, the doctor agreed that the SI joints were causing my pain.

SI joint pain is an often-overlooked cause of back pain, and can be confused with disk pain. It’s important to find any and all causes of persistent back pain because the treatments can be different.

Some years later, I agreed to try steroid injections into the SI joints, despite the effect I knew it would have on my blood sugar. Steroids can also make your body resistant to insulin.  I figured it was worth the risk if there was a chance at pain reduction. However, I knew that it would not be something that I could do regularly, and while not 100% helpful, there was some temporary modest relief. 

Since then, I’ve been able to identify what triggers the SI joint pain, and I use several different modalities for relief, including ice, low-dose oral steroids, stretches, and prescription pain medication.

How to Tell the Difference

Pain that is from a bulging or herniated disk can radiate down one leg and cause numbness or tingling. This pain is usually centered in the lower back, whereas pain from the SI joints can be pinpointed to one side or both. Pain from a bad disk can travel all the way down to the feet or toes, while SI joint pain usually stays above the knee.

Leg weakness can be very severe in a disk rupture, even to the point where you are dragging your foot. If you lose bowel or bladder control, that may be a sign of a serious condition called cauda equina syndrome and is considered a medical emergency!

Weakness in a leg from SI joint dysfunction usually isn’t prominent, but you can have numbness and tingling. SI joint pain can be triggered by going from a sitting to a standing position or by sleeping on one side. A trip or a stumble can also set off SI joint pain, and sitting for long periods of time can make either condition worse. Bending or twisting can aggravate a bulging or herniated disk.

While it’s always helpful to pay close attention to your symptoms, imaging is usually necessary. MRI is a valuable tool to get a good look at bulging or herniated disks. I would also keep a pain diary to make a note of what your pain triggers are and where the pain occurs. Make a note also of what relieves the pain (if anything).

All of these things can be helpful with assisting your doctor in making a proper diagnosis. Only until you get the correct diagnosis can you take steps to begin treatment and possibly achieve some lasting relief.

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

Chronic Pain Worsened for Many During Pandemic

By Pat Anson, PNN Editor

Nearly nine out of ten people with chronic pain say their symptoms have either not improved (51%) or gotten worse (36%) during the pandemic, according to a new Harris poll that found nearly half of respondents (44%) experienced delays in getting treatment due to Covid-19.

The online survey of 810 U.S. adults with chronic back or leg pain was conducted in October and November 2021. It was commissioned by Medtronic, which makes spinal cord stimulators and other neuromodulation devices that treat pain.

Nine in ten pain sufferers said pain impacts their lives on a daily basis, with poor sleep (63%) being the most common reported problem. Pain also negatively affects their mental health (60%), exercise habits (53%), mobility and function (51%), ability to enjoy hobbies (44%), social life (32%) and occupation (33%).

Over one in five (22%) said pain impacts their romantic relationships, including being intimate with a partner or spouse.

"This data bears out what we've heard from our clinician customers and patients for two years – the pandemic has been especially hard on those with chronic pain," Charlie Covert, Vice President & General Manager of Interventional Pain Therapies at Medtronic, said in a press release.

The survey found that nearly one in five pain sufferers (17%) said they have canceled a medical appointment or procedure without rescheduling, with the primary reason being fear of Covid-19 exposure. Only a third of surveyed patients (34%) feel comfortable going into a healthcare facility, and 5% say they will never feel comfortable returning to their provider.

The overwhelming majority of respondents (90%) wish there were more treatment options available to manage their pain. While most are aware of traditional treatments such as physical therapy and oral pain relievers, far fewer are familiar with options such as targeted drug delivery (38%) or spinal cord stimulation (34%).

"There is a tangible human cost to deferred procedures and delayed care. As COVID-19 hopefully begins its transition to a more endemic disease, we expect many of these patients to urgently seek relief through new or more effective treatment modalities,” said Covert. “Our survey demonstrated that an overwhelming majority want more treatment options, yet awareness of spinal cord stimulation and targeted drug delivery options remains relatively low."

The pandemic continues to affect the bottom line for Medtronic. Last month, the company said revenue losses were in the “low-double digits” for its neuromodulation and pain therapy devices.

In a conference call with analysts, Medtronic said the surge of omicron infections in January created “acute periods of worker absenteeism” with its customers, suppliers and staff. While conditions are improving, the company expects pandemic-related issues such as inflation, supply chain issues and healthcare worker shortages to linger.

How the Epstein Barr Virus Causes Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

The Epstein-Barr Virus (EBV) has long been known to cause autoimmune complications. For example, I described infectious mononucleosis in kidneys (glomerulonephritis) associated with EBV back in 1969, some 53 years ago.

Recently EBV has been shown to cause multiple sclerosis (MS), as well as certain cancers. Our studies have also revealed that many, if not the majority, of persons with adhesive arachnoiditis (AA) have extremely high EBV antibody levels. We now believe that EBV can cause AA as well as MS. 

Anything that boosts or helps a disorder to develop, is called a “co-factor.” In the case of EBV and AA, the “co-factors” or “co-partners” may include Ehlers-Danlos Syndromes, autoimmune diseases such as psoriasis, Lyme disease, and some other viruses like cytomegalus, coxsackie and covid.

‘Collagen Eaters’

Although almost everyone gets infected with EBV during their lifetime, some persons develop a large number of EBV antigens that literally attack and “eat away” or otherwise cause collagen to deteriorate and weaken. If the body creates large numbers of antigens, large numbers of antibodies are simultaneously made to hopefully counter them.

EBV collagen eating antigens like to attack tissues around the spine that have a lot of collagen. This includes intervertebral discs, cauda equina nerve roots, and the arachnoid-dural covering of the spinal canal. If collagen is weak or absent in spinal tissues, discs may slip, inflammation may form, and fluid leaks and cysts may develop.

Get Tested for EBV

All persons with confirmed or suspected AA should be tested for EBV antibodies.

Laboratories today do three types of tests for EBV. One is to tell if you currently have an active infection and the other two measure antibody levels to determine if you have had EBV in the past. If your antibodies are considerably above normal range, it suggests you have collagen eating antigens that put you at risk of developing AA.

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

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

Closed Pain Clinics Were ‘Always Pushing Injections’

By Anna Maria Barry-Jester and Jenny Gold, Kaiser Health News

On May 13 of last year, the cellphones of thousands of California residents undergoing treatment for chronic pain lit up with a terse text message: “Due to unforeseen circumstances, Lags Medical Centers will be closing effective May 19, 2021.”

In a matter of days, Lags Medical, a sprawling network of privately owned pain clinics serving more than 20,000 patients throughout the state’s Central Valley and Central Coast, would shut its doors. Its patients, most of them working-class people reliant on government-funded insurance, were left without ready access to their medical records or handoffs to other physicians.

Many patients were dependent on opioids to manage the pain caused by a debilitating disease or injury, according to alerts about the closures that state health officials emailed to area physicians. They were sent off with one final 30-day prescription, and no clear path for how to handle the agony — whether from their underlying conditions or the physical dependency that accompanies long-term use of painkillers — once that prescription ran out.

The closures came on the same day that the California Department of Health Care Services suspended state Medi-Cal reimbursements to 17 of Lags Medical’s 28 locations, citing without detail “potential harm to patients” and an ongoing investigation by the state Department of Justice into “credible allegations of fraud.”

In the months since, the state has declined to elaborate on the concerns that prompted its investigation. Patients are still in the dark about what happened with their care and to their bodies.

photo by Kathleen Hayden (KHN)

Even as the government remains largely silent about its investigation, interviews with former Lags Medical patients and employees, as well as KHN analyses of reams of Medicare and Medi-Cal billing data and other court and government documents, suggest the clinics operated based on a markedly high-volume and unorthodox approach to pain management. This includes regularly performing skin biopsies that industry experts describe as out of the norm for pain specialists, as well as notably high rates of other sometimes painful procedures, including nerve ablations and high-end urine tests that screen for an extensive list of drugs.

Those procedures generated millions of dollars in insurer payments in recent years for Lags Medical Centers, an affiliated network of clinics under the ownership of Dr. Francis P. Lagattuta. The clinics’ patients primarily were insured by Medicare, the federally funded program for seniors and people with disabilities, or Medi-Cal, California’s Medicaid program for low-income residents.

Taken individually, the fees for each procedure are not eye-popping. But when performed at high volume, they add up to millions of dollars.

Take, for example, the punch biopsy, a medical procedure in which a circular blade is used to extract a sample of deep skin tissue the size of a pencil eraser. The technique is commonly used in dermatology to diagnose skin cancer but has limited use in pain management medicine, usually involving a referral to a neurologist, according to multiple experts interviewed. These experts said it would be unusual to use the procedure as part of routine pain management.

KHN used Medi-Cal records to assess the volume of services performed across the entire chain. But the state could not provide totals for how much Lags Medical was reimbursed because of California’s extensive use of managed-care plans, which do not make their reimbursement rates public. Where possible, KHN estimated the worth of Medi-Cal procedures based on the set rates Medi-Cal pays traditional fee-for-service plans, which are public.

Lags Medical clinics performed more than 22,000 punch biopsies on Medi-Cal patients from 2016 through 2019, according to state data. Medi-Cal reimbursement rates for punch biopsies changed over time. In 2019 the state’s reimbursement rate was more than $200 for a set of three biopsies performed on patients in fee-for-service plans.

Laboratory analysis of punch biopsies was worth far more. Lags Medical clinics sent biopsies to a Lags-affiliated lab co-located at a clinic in Santa Maria, according to medical records and employee interviews. From 2016 through 2019, Lags Medical clinics and providers performed tens of thousands of pathology services associated with the preparation and examination of tissue samples from Medi-Cal patients, according to state records. The services would have been worth an estimated $3.9 million using Medi-Cal’s average fee-for-service rates during that period.

In that same period, Medicare reimbursed Lagattuta at least $5.7 million for pathology activities using those same billing codes, federal data shows.

‘Assembly Line’ Pain Care

Much of the work at Lags Medical was performed by a relatively small number of nurse practitioners and physician assistants, each juggling dozens of patients a day with sporadic, often remote supervision by the medical doctors affiliated with the clinics, according to interviews with former employees. Lagattuta himself lived in Florida for more than a year while serving as medical director, according to testimony he provided as part of an ongoing malpractice lawsuit that names Lagattuta, Lags Medical, and a former employee as defendants.

Former employees said they were given bonuses if they treated more than 32 patients in a day, a strategy Lagattuta confirmed in his deposition in the malpractice lawsuit. “If they saw over, like, 32 patients, they would get, like, $10 a patient,” Lagattuta testified.

The lawsuit, filed in Fresno County Superior Court, accuses a Lags Medical provider in Fresno of puncturing a patient’s lung during a botched injection for back pain. Lagattuta and the other named defendants have denied the incident was due to negligent treatment, saying, in part, the patient consented to the procedure knowing it carried risks.

Hector Sanchez, the nurse practitioner who performed the injection and is named in the lawsuit, testified in his own deposition that providers at the Lags Medical clinic in Fresno each treated from 30 to 40 patients on a typical workday.

According to Sanchez’s testimony and interviews with two additional former employees, Lags Medical clinics also offered financial bonuses to encourage providers to perform certain medical procedures, including punch biopsies and various injections. “We were incentivized initially to do these things with cash bonuses,” said one former employee, who asked not to be named for fear of retribution. “There was a lot of pressure to get those done, to talk patients into getting these done.”

In his own deposition in the Fresno case, Lagattuta denied paying bonuses for specific medical procedures.

‘Injections, Injections, Injections’

Interviews with 17 former patients revealed common observations at Lags Medical clinics, such as crowded waiting rooms and an assembly-line environment. Many reported feeling pressure to consent to injections and other procedures or risk having their opioid supplies cut off.

Audrey Audelo Ramirez said she had worried for years that the care she was receiving at a Lags Medical clinic in Fresno was subpar. In the past couple of years, she said, there were sometimes so many patients waiting that the line wrapped around the building.

Ramirez, 52, suffers from trigeminal neuralgia, a rare nerve disease that sends shocks of pain across the face so severe it’s known as the “suicide disease.” Over the years, Lags Medical had taken over prescribing almost all her medications. This included not only the opioids and gabapentin she relies on to endure excruciating pain, but also drugs to treat depression, anxiety, and sleep issues.

Ramirez said she often felt pressured to get procedures she didn’t want. “They were always just pushing injections, injections, injections,” she said. She said staffers performed painful punch biopsies on her that resulted in an additional diagnosis of small fiber neuropathy, a nerve disorder that can cause stabbing pain.

She was among numerous patients who said they felt they needed to undergo the recommended procedures if they wanted continued prescriptions for their pain medications. “If you refuse any treatment they say they’re going to give you, you’re considered noncompliant and they stop your medication,” Ramirez said.

She said she eventually agreed to an injection in her face, which she said was administered without adequate sedation. “It was horrible, horrible,” she said. Still, she said, she kept going to the office because there weren’t many other options in her town.

Lagattuta, through his lawyer, declined a request from KHN to respond to questions about the care provided at his clinics, citing the state investigation. “Since there is an active investigation, Dr. Lagattuta cannot comment on it until it is completed,” attorney Matthew Brinegar wrote in an email. Lagattuta’s license remains in good standing, and he said in his deposition in the Fresno lawsuit that he is still seeing patients in California.

Experts interviewed by KHN noted that medical procedures such as injections can have a legitimate role in comprehensive pain management. But they also spoke in general terms about the emergence of a troubling pattern at U.S. pain clinics involving the overuse of procedures. In the 1990s and early 2000s, problematic pain clinics hooked patients on opioids, then demanded cash to continue prescriptions, said Dr. Theodore Parran, who is a professor of medicine at Case Western Reserve University and has served as an expert witness in federal investigations into pain clinics.

“What has replaced them are troubled pain clinics that hook patients with the meds and accept insurance, but overuse procedures which really pay well,” he said. For patients, he added, the consequences are not benign.

“I mean they are painful,” he said. “You’re putting needles into people.”

Cash Bonuses for Procedures

Before moving to California in 1998, Dr. Francis Lagattuta lived in Illinois and worked as a team doctor for the Chicago Bulls during its 1995-96 championship season. Out West, he opened a clinic in Santa Maria, a Latino-majority city along California’s Central Coast known for its strawberry fields, vineyards, and barbecue. From 2015 to 2020, the chain grew from a couple of clinics in Santa Barbara County to dozens throughout California, largely in rural areas, as well as far-flung locations in Washington state, Delaware, and Florida.

The California portion of the chain is organized as more than two dozen corporations and limited liability corporations owned by Lagattuta. His son, Francis P. Lagattuta II, was a manager for the company.

On the Lags Medical website and in conversation with employees, the elder Lagattuta claimed he was on the vanguard of diagnosing and treating small fiber neuropathy. Much of the website has now been taken down. But pages available via an archival site claim he had pioneered a three-pronged approach to pain management that made minimal use of opioids and surgeries, instead emphasizing testing, injections, mental health, diet, and exercise.

“In keeping with his social justice values, Dr. Lagattuta plans to share these findings to the rest of the world, hopefully to help solve the opioid crisis, and end suffering for millions of people struggling with pain,” touted a biography once highlighted on the website.

Dr. Francis Lagattuta (Twitter)

Numerous Lags Medical patients interviewed by KHN said that even when they were given punch biopsies and a subsequent diagnosis of neuropathy, their treatment plan continued to involve high doses of opioid medications.

Dr. Victor C. Wang, chief of the division of pain neurology at Brigham and Women’s Hospital in Boston, said punch biopsies are occasionally used in research but are not a standard part of pain medicine. Instead, small fiber neuropathy is usually diagnosed with a simple clinical exam.

“The treatment is going to be the same whether you have a biopsy or not,” said Wang. “I always tell the fellows, you can do this test or that one, but is it really going to change the management of the patient?”

Ruby Avila, a mother of three in Visalia, remembers having the punch biopsies done at least three times during her four years as a Lags Medical patient. “I have scars down my leg,” she said. Each time, she said, providers removed a set of three skin specimens that were used to diagnose her with small fiber neuropathy.

Avila, 37, who has lived with pain since childhood, had found it validating to finally have a diagnosis. But after learning more about how common the biopsies were at Lags Medical, she was shaken. “It’s overwhelming to hear that they were doing it on a lot of people,” she said.

Sanchez, the nurse practitioner named in the Fresno lawsuit, spoke of other procedures that garnered bonuses: “Trigger point injections, knee injections, hip injections, foot injections for plantar fasciitis and elbow injections” all qualified for $10 bonuses, he said in his testimony.

Two former employees, who asked not to be named, echoed Sanchez, saying they were incentivized to do certain procedures, including injections and punch biopsies.

In his testimony in the Fresno case, Lagattuta denied paying bonuses for procedures. “It was only for the patients,” he said. “We never did it based on procedures.”

Incentive systems for a specific procedure are “completely unethical,” said Dr. Michael Barnett, an assistant professor of health policy at Harvard. “It’s like giving police officers a quota for speeding tickets. What do you think they’re going to do? I can’t think of any justification.”

Dr. Carl Johnson, 77, is a pathologist who directed Lags Medical’s Santa Maria lab from 2018 to 2021. Johnson said the only specimens he looked at came from punch biopsies, the first time in his long career as a pathologist that he had been asked to run such an analysis. On an average day, he said, he examined the slides of about 40 patients, searching for signs of small fiber neuropathy. Lagattuta gave him papers to read on peripheral neuropathy and assured him they were on the cutting edge of care for pain patients.

Johnson said he “never thought there was anything untoward going on” until he arrived on his last day and was told to pack up his belongings because the entire operation was shutting down.

Nerve Ablations and Drug Tests

Lags Medical performed other procedures at rates that also set them apart. From 2015 through 2020 — the span for which KHN had state data — Lags Medical performed more than 24,000 nerve ablations, a procedure in which part of a nerve is destroyed to reduce pain, on Medi-Cal patients. That’s more than 1 in 6 of all nerve ablations billed through Medi-Cal during that period.

An analysis of federal data also shows Lagattuta was an outlier. For example, in 2018 he billed Medicare for nerve ablations more often than 88% of the doctors in his field who performed the procedure.

Lags Medical also used the in-house lab to run drug tests on patients’ urine samples. From 2017 through 2019, Lags Medical facilities often ordered the most extensive — and expensive — set of drug tests, which check for the presence of at least 22 drugs, according to state and federal data.

For perspective, in 2019, more than 23,000 of the most extensive drug tests were ordered on Medi-Cal patients under Lagattuta’s provider number, more than double the number tied to the next highest biller. The next five top billers were all lab companies.

Overall, from 2017 through 2019, nearly 60,000 of the most extensive drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for these tests during that period. Using state fee-for-service rates, the testing billed to Medi-Cal would have been worth an estimated $6.3 million. That doesn’t include less extensive drug screens or those billed under other providers’ numbers.

Pain management experts described the use of extensive screening as unnecessary in routine pain treatment; the overuse of such tests has been the subject of numerous Medicare investigations in recent years.

Private pain clinics like Lags Medical are only loosely regulated and generally are not required to hold a special license from the state. But the physicians who work there are regulated by the Medical Board of California.

In December 2019, a patient who’d visited clinics in both Visalia and the Central Coast filed a complaint against Lagattuta with the medical board claiming, among other things, that she received biopsies that were not properly performed, that she underwent excessive testing, and that positive drug tests had been falsified. The medical board had another pain management doctor review more than 300 pages of documents and found “no deviations from the standard of care” and “did not find any over testing, or improperly performed biopsies.”

He did, however, find some record-keeping problems, including numerous procedures in which patient consent was not documented. He also found instances in which procedures were performed and repeated without documentation that they were effective. The patient who filed the complaint was given a medial branch nerve block in November 2014, followed by a radiofrequency ablation in December, and another in February. No improvements for the patient were ever noted in the charts, the investigating doctor found.

The medical board chalked it up to a record-keeping error and fined Lagattuta $350.

Opioids Needed for ‘Halfway-Normal Life’

On a warm evening in late July, Leah Munoz drove her power wheelchair around the long plastic tables at the Veterans Memorial Building in Hanford, a dusty farm town in California’s Central Valley. Senior bingo night was crowded with gray-haired players waiting for the game to begin. She found an empty spot and carefully set out $50 worth of bingo cards, alongside her collection of 14 brightly colored daubers.

Munoz, 55 and a mother of six, said she has suffered from a litany of illnesses — thyroid cancer, breast cancer, lupus, osteoarthritis — that leave her in near-constant pain. She’s been playing bingo since she was a little girl, and said it helps distract from the pain and calm her mind. She looks forward to this event all week.

Munoz was a Lags Medical patient for about four years and, while her pain never disappeared, the opioids prescribed provided enough relief for her to continue doing the things she loved. “There’s a difference between addiction and dependence. I need it to live a halfway-normal life,” Munoz said.

leah and ramon munoz

After Lags Medical closed in May, her primary care doctor initially refused to refill her opioid prescriptions. She said she called the Lags Medical offices to try to get a copy of her medical records to prove her need, and even showed up in person. But she said she was unable to get them. As the pills dwindled and the pain surged, Munoz said, it became hard to leave her home. “I missed a lot of bingo, a lot of grocery shopping, a lot of going to my grandkids’ birthday parties. You miss out on life,” she said. Ultimately, she said, her primary care doctor referred her to another pain clinic, and she was able to resume her prescription.

Even with pain medications, Munoz said, she never received true relief during her time as a patient at Lags Medical. She said she felt coerced to get several injections, none of which seemed to help. “If I didn’t get the procedures, I didn’t get the pain medication,” she said. Her husband, Ramon, a landscaper who was also a patient, received an injection there that he said left him with permanent stiffness in his neck.

Munoz knows at least five other people at bingo night who were former patients at Lags Medical. One of them, Rick Freeman, came over to her table to chat. He swayed back and forth as he walked, his knees, he explained, swollen after 35 years living with HIV. At Lags Medical, Freeman said, he felt pressured by staff to receive injections if he wanted to continue receiving his opioid prescriptions. “If you don’t cooperate with them, they would reduce your meds down,” he said.

At the front of the room, Gail Soto, who ran the event, sold bingo cards to the latecomers. Soto, 72, said she injured her back while working an administrative job at a construction company years ago and suffers from spinal stenosis, rheumatoid arthritis, and fibromyalgia. She, too, was a patient at Lags Medical for years. In addition to her opioid prescription, Soto said, she received repeated injections and three nerve ablations. At first, the ablations helped, but what staff members didn’t tell her, she said, was that the nerves they destroyed could grow back. Ultimately, she said, the procedures left her in worse pain.

Soto’s biggest concern is the spinal stimulator that she said Lags Medical surgically inserted into her back five years ago. She said the doctors told her the device would work so well that she would no longer need her pain pills. She said they didn’t explain that the device would work only two hours a day, and on one side of her body. She remained in too much pain to give up her meds, she said, and, five years later, the battery is failing.

Soto sleeps in a recliner chair in her three-bedroom mobile home in Lemoore, another small city near Hanford. It’s well kept but humble, and she and her husband keep a collection of wind chimes on the front porch that create a wave of gentle music when a breeze passes by.

The couple take good care of each other and their two beloved Chihuahuas, but life has become increasingly difficult for Soto. As the battery on her spinal stimulator has started to fail, she said, she has sudden electrical pulses that shoot up her body.

GAIL SOTO

“My husband says sometimes when I sleep that my body will just jump up in the air,” she said. But now that Lags Medical is closed, she said, she can’t find a doctor willing to remove the device. “Most doctors are telling me right now, ‘We can’t, because we didn’t [put it in]. We don’t want nothing to do with that.’”

Waitlists and Withdrawal

Audrey Audelo Ramirez said she picked up her final refill from Lags Medical on June 4 and by July 4 had no meds left to treat her pain. Ramirez said she called every pain management clinic in Fresno, but none were taking new patients.

“They left us all high and dry,” she said. “Everybody.”

In the weeks that followed the closures, county officials throughout the Central Valley saw a flood of patients on high doses of opioids in search of new providers, they said. Patients couldn’t access their medical records, so other providers had no idea what their treatments had been.

“We had to create a crisis response to it because there was no organized response at that time,” said Dr. Rais Vohra, the interim health officer for Fresno County.

Fresno County’s health system is already lean, Vohra said. Toss in this abrupt closure and you end up in the kind of crisis rarely seen in other fields of medicine: “You’d never do this with a cancer clinic,” he said. “You’d never abruptly stop chemo.”

The state asked Dr. Phillip Coffin, director of substance abuse research for the San Francisco Department of Public Health, to run provider training and persuade doctors to take on new patients. Many practices have rules against taking new patients on opioids, or will refuse to prescribe doses above certain thresholds.

“We know that when you stop prescribing opioids, some people end up with death from suicide, overdose, increased illicit opioid use, pain exacerbations. It’s really important to have a continuity, and that is not really possible in the current opioid-prescribing culture,” Coffin said. The threat to patients is so severe that the FDA issued a warning in 2019 against cutting patients off from prescription opioids.

Gina, a retired nurse who asked to be identified by only her first name for fear she’d be discriminated against by other doctors, had been a Lags Medical patient for six years. She said she called every practice she could find in her Central Coast town, and was put on a waiting list at one. Suffering from a severe case of scoliosis, she started rationing the pain pills she had come to rely on.

When she finally secured an appointment, she said, she was told by the doctor she was on “some very strong meds” and he would fill only one of her two prescriptions. “You’re like a criminal,” she said. “You’re branded as ‘we don’t trust you.’”

She started experiencing withdrawal symptoms — sweating, lost appetite, sleeplessness, anxiety. Worst of all, her pain “came back with a vengeance,” she said.

“I think about this, what I’d have been like if I’d never gone through pain management. I sometimes wonder if I’d be better off.”

As for Ramirez, her primary care doctor finally secured an appointment for her at another pain clinic, she said. It was in the same space as the old Lags Medical clinic, and she said she recognized many of the staff members. But now there was a new name: Central California Pain Management. From her perspective, it was as if nothing had changed. And she still doesn’t know whether she needs to worry about the care she received during more than four years at Lags Medical.

This story was produced by Kaiser Health News. Senior correspondent Jordan Rau and Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.