MindMed Investigating Use of Psychedelics to Treat Chronic Pain

By Pat Anson, PNN Editor

A startup pharmaceutical company has announced plans to investigate the use of LSD and other psychedelics to treat chronic pain.

New York-based Mind Medicine (MindMed) is exploring the use of psychedelics to treat two pain conditions, which it is calling “Project Angie.” The company is already investigating the use of psychedelics to treat addiction, anxiety and attention deficit hyperactivity disorder (ADHD).

"With the launch of Project Angie, we seek to align closely with MindMed's core mission to improve mental health and combat substance use for the many patients in need. If we can help to develop a new paradigm to treat pain, it may have the potential to greatly reduce the use of addictive medicines such as opioids currently ravaging society and its mental health," MindMed CEO & Co-Founder J.R. Rahn said in a statement.

MindMed did not disclose what pain conditions it was developing treatments for, but it is working with researchers in Switzerland who have a Phase 2 clinical trial underway on the use of LSD to treat cluster headache. The company said it is also evaluating a second indication for a “common, often debilitating, chronic pain syndrome.”

Interest in using psychedelics to treat medical conditions has been growing in recent years. Preliminary research suggests that microdoses of LSD, psilocybin (magic mushrooms) and other psychedelics may offer a new way to treat pain. The exact mechanism in which psychedelics have an analgesic effect is not fully understood, but early research indicates that LSD can modulate serotonin receptors that help regulate pain and inflammation.

"Evidence dating back to the 1950s suggests that LSD and other psychedelics may have analgesic effects, but this treatment area remains largely untapped by companies studying psychedelics, with the majority of research focusing solely on psychiatric indications," said Rob Barrow, MindMed’s Chief Development Officer. 

The company is planning to submit a Pre-Investigational New Drug (IND) application to the Food and Drug Administration for a Phase 2a proof of concept study of LSD (lysergic acid diethylamide) in the second half of 2021.

MindMed will have to clear some high regulatory hurdles. LSD, psilocybin, MDMA (Ecstasy) and other psychedelics are classified as Schedule I controlled substances, meaning they have a high potential for abuse and currently have no accepted medical use in the United States.

Pilot Study Shows Neuromodulation Effective for Postoperative Pain

By Pat Anson, PNN Editor

In recent years, many U.S. hospitals have adopted policies that reduce or eliminate the use of opioids after surgery. For some, that means giving their patients Tylenol or Lyrica for postoperative pain. For others, it means trying neuromodulation — a non-pharmacological therapy that new research shows may have some potential.

In a placebo-controlled pilot study led by researchers at University of California San Diego, patients who received percutaneous peripheral nerve stimulation (PNS) had significant reductions in their pain levels after outpatient joint surgery.

Percutaneous PNS is a form of neuromodulation that involves the placement of a tiny wire or “lead” alongside a peripheral nerve. The implanted lead is then connected to a small external pulse generator that sends a mild electric current to the nerve, interrupting pain signals. PNS has been used for years to treat chronic pain, but this was the first clinical trial to assess its use for postoperative acute pain.    

In the pilot study, 65 adult patients scheduled for operations on their shoulders, knees or ankles had leads placed before surgery in the affected joint. After surgery, half of the patients were given neuromodulation, while the other half received a "sham" treatment with a pulse generator that appeared active but did not deliver any electric current.

Patients in both groups received opioids as needed for their postoperative pain, and after one week their pain scores and opioid use were compared.

Researchers reported in the journal Anesthesiology that the results were “much greater than we had anticipated.” Pain scores were over 50 percent lower in patients who received neuromodulation. The mean pain score (on a zero to ten scale) was 1.1 in patients receiving PNS treatment, compared to 3.1 in the sham group.

Nerve stimulation was also associated with an 80 percent reduction in opioid consumption. The median opioid dose (oral morphine equivalent) in the first week after surgery was 5 milligrams in the active treatment group, compared to 48 milligrams in the sham group.

“This multicenter, randomized, double-masked, sham- controlled pilot study provides evidence that ultra-sound-guided percutaneous peripheral nerve stimulation concurrently improves analgesia and decreases opioid requirements to a statistically significant and clinically meaningful degree for at least a week after moderately to severely painful ambulatory orthopedic surgery,” wrote lead author Brian Ilfeld, MD, a professor of anesthesiology at UC San Diego.

Ilfeld and his colleagues say the pain-relieving benefits of neuromodulation continued after the leads were removed 14 days after surgery, but they appeared to wear off after one month. They plan on conducting a larger clinical trial with 250 surgery patients and to follow them for a year to see if there are any long-term benefits from neuromodulation.

Contrary to popular belief, opioid addiction is rare after surgery. A large 2016 study found only 0.4% of older adults were still taking opioids a year after major elective surgery. Another large study in 2018 found only 0.2% of patients who took opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or had a non-fatal overdose.

Nevertheless, the now defunct American Pain Society (APS) released guidelines in 2016 that encourage physicians to use non-opioid medication such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurotin) and pregabalin (Lyrica) for post-operative pain. The APS also recommended non-pharmacological therapies such as cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS) as adjunct treatments.

The lead author of the APS guideline was Roger Chou, MD, who also co-authored the 2016 CDC opioid guideline.

Injections of Tiny Particles Reduce Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

A minimally invasive procedure significantly reduces pain and inflammation caused by knee osteoarthritis, according to preliminary research being presented this week at the annual meeting of the Society of Interventional Radiology.

Geniculate artery embolization (GAE) is a relatively new procedure in which thousands of microscopic particles are injected into arthritic knees. The particles reduce inflammation by disrupting the abnormal flow of blood caused by osteoarthritis (OA), a joint disorder that causes thinning of cartilage and progressive joint damage. As the cartilage breaks down, it releases enzymes that cause inflammation and pain.

GAE takes about one to two hours, and many patients with knee OA report significant improvement in pain and physical function that can last up to a year.

"Prior to treatment, patients' knee pain had taken over their whole life," said lead researcher Siddharth Padia, MD, a professor of radiology at UCLA Health. "But after treatment, patients who initially could walk only three or four blocks were walking three miles. Some were able to do away with walking aids, such as canes, while others reported being in a better mood now that they were living without pain."

For their Phase 2 study, Padia and his colleagues enrolled 40 patients with knee OA who were not candidates for total knee replacement, and who failed to benefit from pain relievers, joint injections and physical therapy.

Catheters were inserted into arteries leading to the knees through pinhole incisions in the patients’ hips. The microscopic particles — called Embozene microspheres — were then slowly injected through the catheter into the knees. Each patient was evaluated for pain and adverse events at one week; one, three and six months; and one year after the treatment.

Researchers say patients saw benefits as soon as three days after the procedure. Average pain levels decreased from 8 out of 10 before GAE to 3 out of 10 within the first week. Most patients reported more than 50% reduction in their pain levels at the one-year follow up.

Adverse events, such as skin ulceration and small bone infarction – the death of bone tissue due to reduced blood supply -- were reported by 9 patients, but resolved without treatment.

Embozene microspheres are made by Boston Scientific and are currently used in the treatment of vascular tumors, uterine fibroids and arterial malformations. They must be carefully injected into affected tissue to prevent them from circulating in the blood and reaching healthy tissue and organs.

“This prospective trial demonstrates that GAE is highly effective and durable in reducing symptoms due to moderate to severe knee OA that is refractory to other conservative therapy, and has an acceptably low toxicity profile,” researchers concluded.

The UCLA researchers plan to conduct a larger, randomized trial to determine which patients may benefit most from GAE and the impact it has on slowing the progression of arthritis.

Results from other studies on the use of GAE are also being presented at the meeting of the Society of Interventional Radiology. One review found that GAE can be effective for patients who don't respond well to conservative treatments for knee OA, but cautioned that “definitive conclusions can't be made on the true efficacy of GAE until studies are done with longer follow up and larger patient numbers.”

Low-Dose Ketamine Effective in Treating Trauma Pain

By Pat Anson, PNN Editor

Low doses of ketamine are just as effective at treating trauma pain in emergency room patients as larger standard doses, according to a new study by researchers at Loyola University Medical Center in Chicago.

Ketamine is a non-opioid that’s been used for decades as a surgical anesthetic, but in recent years it’s increasingly being used to treat short-term acute pain in hospital emergency rooms. A standard dose of ketamine administered intravenously is 0.30 mg/kg, but Loyola researchers wanted to see if half the normal dose could be just as effective.

"We challenged the conventional ketamine dose used to treat pain," said lead study author Shannon Lovett, MD, an emergency physician at Loyola University Medical Center (LUMC). "Our study should help demonstrate that a lower dose is sufficient to treat pain."

Lovett and her colleagues recruited 98 patient volunteers who were in moderate to severe acute pain. Half received just 0.15 mg/kg of IV ketamine, while the other half received the standard dose. Both patients and providers were “blinded” on which dose was being administered.

After 15 minutes, patients in the standard dose group had a greater reduction in pain, but experienced more side effects such as dizziness, mood changes and hallucinations. After 30 minutes, adverse events and pain levels were similar in both dosing groups.

Asked if they would take ketamine again, 76% of patients in the low-dose group said yes, while only 62% in the standard dose group said they would.

"As we continue with our research, we hope to find data that supports diminished side effects with the lower dose of ketamine with equal efficacy in treating pain," said senior author Megan Rech, PharmD, an emergency medicine pharmacist at LUMC.

The study findings are reported in the journal Academic Emergency Medicine.

Researchers said there is “robust evidence supporting the use of ketamine as an alternative to traditional opioids across a wide range of doses,” but its effectiveness is usually short-lived. Ketamine does not have a significant analgesic effect after 60 minutes. It also puts patients into a hypnotic, dream-like state in which they appear awake, but are unresponsive. For that reason, ketamine is only administered under medical supervision.

A growing number of outpatient clinics provide off-label infusions of ketamine for depression, post-traumatic stress disorder (PTSD) and difficult chronic pain conditions such as Complex Regional Pain Syndrome (CRPS). The infusions are usually not covered by insurance.

A pilot study is underway to see if an oral version of ketamine and aspirin, combined in a tablet, could be used to treat pain at home.

Experimental Gene Therapy May Relieve Chronic Pain

By Pat Anson, PNN Editor

A new study by researchers at the University of California San Diego suggests that gene therapy could someday be used to treat a variety of chronic pain conditions without the use of drugs.

In experiments on laboratory mice, researchers found that temporarily repressing a gene involved in sensing pain increases pain tolerance, lowers pain sensitivity and provided months of pain relief without causing numbness. Their findings were published in the journal Science Translational Medicine.

“What we have right now does not work,” said first author Ana Moreno, PhD, CEO of Navega Therapeutics, which is developing gene therapies to treat chronic pain. “There’s a desperate need for a treatment that’s effective, long-lasting and non-addictive.”

Moreno was grad student at UC San Diego studying gene repression when she came across a paper about a genetic mutation that causes humans to feel no pain. The mutation blocks a protein -- called NaV1.7 -- that’s involved in transmitting pain signals in the spinal cord.

That’s when she came up with the idea of suppressing the gene using the CRISPR gene editing tool. Moreno was working with a version of CRISPR that uses what’s called “dead” Cas9, which lacks the ability to permanently cut DNA. Instead, it sticks to a gene and temporarily blocks its expression.

“By targeting this gene, we could alter the pain phenotype,” Moreno explained. “It’s not cutting out any genes, so there are no permanent changes to the genome. You wouldn’t want to permanently lose the ability to feel pain.

“One of the biggest concerns with CRISPR gene editing is off-target effects. Once you cut DNA, that’s it. You can’t go back. With dead Cas9, we’re not doing something irreversible.”

Moreno and UC San Diego bioengineering professor Prashant Mali, PhD, co-founded Navega Therapeutics to work on developing gene therapy as a treatment for pain.  They teamed up with Tony Yaksh, PhD, a professor of anesthesiology and pharmacology at UC San Diego School of Medicine, and developed a CRISPR/dead Cas9 system to target and repress the gene that codes for NaV1.7.

When they administered spinal injections of the system into laboratory mice with inflammatory and chemotherapy-induced pain, the mice displayed higher pain thresholds than mice that did not receive the gene therapy. The treated mice were slower to withdraw a paw from painful stimuli (heat, cold or pressure) and spent less time licking or shaking their paws after being hurt.

The treatment was still effective after 44 weeks in the mice with inflammatory pain and 15 weeks in those with chemotherapy pain. The treated mice did not lose sensitivity or display any changes in normal motor function.

To validate their results, the researchers performed the same tests using another gene editing tool called zinc finger proteins. It’s an older technique than CRISPR, but works the same way. Spinal injections of the zinc fingers into mice produced the same results as the CRISPR-dead Cas9 system.

“We were excited that both approaches worked,” Mali said. “The beauty about zinc finger proteins is that they are built on the scaffold of a human protein. The CRISPR system is a foreign protein that comes from bacteria, so it could cause an immune response. That’s why we explored zinc fingers as well, so we have an option that might be more translatable to the clinic.”

The researchers say this solution could work for a variety of chronic pain conditions, including diabetic neuropathy, sciatica, and chemotherapy pain. They believe their gene therapy platform could also be used to treat short-term acute pain.

“Think of the young athlete or wounded war fighter in which the pain may resolve with wound healing,” Mali explained. “We would not want to permanently remove the ability to sense pain in these people, especially if they have a long-life expectancy. This CRISPR/dead Cas9 approach offers this population an alternative therapeutic intervention—that’s a major step in the field of pain management.”  

Researchers at UC San Diego and Navega are planning further studies of pain-relieving gene therapy on non-human primates. Their goal is to begin human clinical trials in a couple years. Their work is funded by UC San Diego Institutional Funds and the National Institutes of Health.

Low Dose Naltrexone Emerging as Treatment for Intractable Pain

By Forest Tennant, PNN Columnist

A major advance in pain management is the discovery of low-dose naltrexone (LDN), a non-opioid medication used to treat substance abuse. When prescribed off-label, LDN not only relieves pain, but has anti-inflammatory and immune boosting properties on brain and spinal cord tissues. It is now the preferred, first drug of choice for people living with constant, intractable pain.

Only those persons who are not currently on daily opioids should take LDN. A major purpose of LDN is to prevent the necessity of daily opioids, including buprenorphine/Suboxone.

A starting dosage of LDN is usually 0.5 – 1.0 milligrams taken twice a day. The average maintenance dose is about 3 – 5mg given twice a day. The maximum dose is about 7mg taken twice a day.

LDN should ideally be a part of a multi-drug program. A nerve conduction blocker (neuropathic) agent such as gabapentin or diazepam will almost always boost pain relief. A dopamine surrogate such as Adderall, Ritalin or mucuna, is also very helpful.  Routinely recommended are standard anti-inflammatory (e.g., Ketorolac) and tissue healing anabolic agents (e.g., DHEA).

A pain flare medication should also be handy and ready. Some patients taking LDN can occasionally take a low dose of tramadol, codeine or hydrocodone for pain flares. Other flare medications include ketamine, CBD, medical marijuana, ibuprofen (800mg), oxytocin, kratom and ketorolac.

Caution and Warning

Persons who currently take daily opioids must withdraw from opioids before starting LDN. In our studies, patients sometimes became deathly ill if they took LDN while still on opioids. Severe withdrawal may set in, pain relief will diminish and, at worst, a cardiac-adrenal crisis may be precipitated.

If one has Intractable Pain Syndrome and is currently on a regimen including opioids that satisfactorily reduces pain, there is no medical reason to switch to LDN.

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

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

Home-Based Virtual Reality Reduces Chronic Low Back Pain

By Pat Anson, PNN Editor

A new clinical study has found that home-based virtual reality (VR) therapy can significantly reduce pain levels in people suffering from chronic lower back pain. Patients who watched VR programs also reported better mood, reduced stress and that pain interfered less with their sleep.

The study, published in the Journal of Medical Internet Research, is the first controlled trial to compare home-based VR therapy to a “sham” or placebo treatment for chronic pain. The research was funded by AppliedVR, a Los Angeles-based company that is developing therapeutic VR content to help treat pain and other conditions.

Eighty-nine people used the company’s EaseVRx headset daily for eight weeks, immersing themselves in relaxing and meditative VR programs designed to make their pain seem less important, similar to cognitive behavioral therapy. A control group received the sham treatment, watching routine nature scenes with the headset. All participants had chronic low back pain for at least six months.   

By the end of the study, 87 percent of people in the VR group reported less pain intensity, with nearly two-thirds experiencing at least a 30% reduction in pain compared to the control group. There were also significant improvements in sleep, mood and stress in the VR group.

Importantly, the improvements in pain and other symptoms were cumulative over time – meaning the relief was long-lasting and not just when people were watching VR programs.

“If you look at the results graph, you’re able to see the trajectory of pain and pain intensity very reliably declining over the course of the eight weeks. It’s a really strong time trend. It’s not just a random effect,” explained Beth Darnall, PhD, AppliedVR’s chief science advisor.

You can see the graph below. Over the course of 56 days, average pain intensity fell by 43% in patients using the EaseVRx headset, compared to 23% in the control or sham group.

JOURNAL OF MEDICAL INTERNET RESEARCH

Most of the research to date on VR therapy has focused on treating acute pain in hospitalized patients. AppliedVR is trying to demonstrate that virtual reality can also be used to treat chronic pain at home. A small study released last summer showed that home-based VR therapy reduced pain in people with fibromyalgia and chronic low back pain.

Darnall was hesitant to say if there were any pain conditions that VR therapy might not useful for.

“At the end of the day, pain is pain,” said Darnall, who is a pain psychologist at Stanford University. “This basic approach, in which we’re equipping people with self-regulatory skills, is going to be beneficial and broadly applicable for every pain condition.

“We have multiple studies in progress that are testing this device on different populations. It’s really going to be an exciting year, because there’s going to be an explosion of research that’s really going to inform our understanding of how this may help people across different disease conditions.”   

AppliedVR’s headset received breakthrough device designation from the Food and Drug Administration last year. The company hopes to get clearance from the FDA later this year to begin selling the devices. Due to a recent decision by Medicare to start covering breakthrough medical devices, the company is hopeful that private insurers will also start paying for VR therapy. 

Advocacy Group Seeks to Expand Insurance Coverage of Ketamine

By Pat Anson, PNN Editor

A coalition of patients and healthcare providers is launching an effort to expand insurance coverage for ketamine, a non-opioid anesthetic increasingly used to treat chronic pain, depression and post-traumatic stress disorder (PTSD).

Ketamine is typically administered by infusion under strict medical supervision, a process that that can take up to an hour and cost thousands of dollars. The first goal of the Ketamine Taskforce is to get ketamine infusions fully covered by Medicare.

“Medicare doesn’t officially pay for ketamine infusions. What they will pay for is a generic infusion code similar to if someone was getting an antibiotic infused. The level of reimbursement is very low,” says Kimberley Juroviesky, a retired nurse practitioner and task force co-chair who receives ketamine infusions for Complex Regional Pain Syndrome (CRPS). 

“Since these reimbursement rates are so low, the majority of small ketamine clinics don’t accept insurance. This leaves the majority of pain patients without the pain relief they could otherwise be benefiting from.”

Ketamine is approved by the Food and Drug Administration as a surgical anesthetic, but a growing number of ketamine clinics provide off-label infusions for depression, PTSD and difficult chronic pain conditions such as CRPS. The infusions put patients into a hypnotic, dream-like state — leaving them with less physical and emotional pain once the ketamine wears off. Many insurers consider this off-label use experimental.

“If we could get Medicare to officially put ketamine on their schedule as a treatment for chronic pain, this would hopefully raise reimbursement rates to a level where all providers could afford it. Also, this would force private insurers to pay for ketamine infusions as well and no longer refuse to pay saying it’s experimental,” Juroviesky said in an email. 

PNN columnists Barby Ingle and Madora Pennington have both had ketamine infusions, Barby for CRPS and Madora while recovering from foot surgery.

“The swelling in my foot dramatically improved. Chronic, low-grade discomfort along my spine also disappeared. I felt emotional relief from past trauma, from pain and other life experiences,” Madora explained.

“I went into the hospital in a wheelchair, but walked out on my own a week later,” said Barby, after seven days of ketamine infusions. She now gets “booster” infusions four times a year and no longer takes daily pain medication.

Some ketamine users report lingering side effects, such as hallucinations and visual disturbances. Guidelines from the American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine only support ketamine infusions for CRPS and short-term acute pain.

“Excluding CRPS, there was no evidence supporting ketamine infusions for intermediate or long-term improvements in pain," the guidelines warn.

The Ketamine Taskforce is working with a consortium of ketamine clinics, collecting data on the safety and efficacy of infusions. That research will be shared with the Centers for Medicare and Medicaid Services (CMS) in an effort to expand Medicare coverage of ketamine for pain and mental health conditions.

Pilot Study Launched of Ketamine Tablet as Pain Reliever

By Pat Anson, PNN Editor

Ketamine has become a trendy alternative treatment for pain, depression, anxiety and post-traumatic stress syndrome (PTSD). But to get it, you’ll need to get a ketamine infusion, injection or nasal spray – usually under strict medical supervision.

But someday you may be able to take a ketamine tablet at home, just like you would most other medications. A pilot study is underway at a New York City hospital to see if an oral formulation of ketamine and aspirin could be a useful treatment for pain.

“For certain patients, ketamine could be a real game changer,” says Dr. Joseph Habboushe, an emergency room physician and founder of Vitalis Pharmaceuticals. “If you look at pain management and what we have available to send patients home with, it’s really limited. We have NSAIDs. We have opiates. We have other things that sedate. It’s a fairly limited in choice.”

Ketamine is not an opioid and does not suppress respiration, making it relatively safe to use. But in high doses, it puts patients into a dissociative, dream-like state -- making it inappropriate for outpatient use.

What Habboushe and his colleagues hope to demonstrate is that a low dose of ketamine, when combined with aspirin, can be an effective and non-addictive pain reliever that can be used safely at home.

Their observational study at Maimonides Medical Center will enroll 25 patients with acute musculoskeletal pain, who will receive 0.5 mg of oral ketamine administered simultaneously with 325mg of aspirin. Pain scores and adverse events will be recorded at various intervals for up to two hours.

The study is being led by Sergey Motov, MD, an emergency room physician who is passionate about finding alternatives to opioids.

VITALIS PHARAMCEUTICALS

"The need for safe and efficacious analgesics in the emergency department and on an outpatient basis is stronger than ever," Motov said in a statement. “Taking a novel approach to orally-administered ketamine has the potential to move physicians one step closer to successfully combatting the nation's ongoing opioid crisis.”

Vitalis has developed a proprietary formulation of aspirin -- called VTS-Aspirin -- that delivers faster and stronger pain relief than traditional aspirin. Preliminary research indicates that combining VTS-Aspirin with low-dose ketamine may boost its potency.

“This is a proof-of-concept study. If we can demonstrate that ketamine will work orally, then it can be used for acute pain, maybe later chronic pain, maybe depression and all the other indications,” Habboushe told PNN. “If we can achieve that, it will be a breakthrough that will absolutely drive a lot of value to patients by reducing opiate need and reducing their pain in a very significant way. And so, it’s worth studying.”

Vitalis is also studying the use of VTS-Aspirin with fumaric acid as a treatment for multiple sclerosis that has fewer side effects. Also undergoing research is a combination of VTS-Aspirin with niacin as a treatment for high cholesterol.

Breakthrough Medical Devices to Receive Medicare Coverage

By Pat Anson, PNN Editor

Medical device manufacturers are cheering a decision by the Centers for Medicare & Medicaid Services (CMS) to have Medicare begin covering hundreds of “Breakthrough Devices” certified by the Food and Drug Administration.

The FDA’s Breakthrough Device Program was launched in 2018 to speed up the development of innovative technology for the treatment and diagnosis of life-threatening or debilitating medical conditions such as chronic pain. But FDA approval was then followed by a lengthy and costly review process for Medicare coverage, which delayed patient access to the devices.

The Medicare Coverage of Innovative Technology (MCIT) rule change allows Medicare to begin covering breakthrough devices simultaneous to FDA approval, making them immediately available to over 60 million Medicare beneficiaries. The rule change goes into effect March 15.

“Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” CMS Administrator Seema Verma said in a statement. “CMS remains committed to transforming the health care delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, fostering competition, and ensuring quicker access to the most advanced therapies for Medicare beneficiaries while providing them with better value and outcomes.”

The rule change benefits companies like San Francisco-based Bone Health Technologies, which announced last month that its OsteoBoost Vibration Belt had received breakthrough device approval as a treatment for osteopenia, a precursor to osteoporosis.

“We are thrilled by this announcement as it will help us get our potentially life-changing device, affordably into the hands of patients who need it much more quickly,” said Laura Yecies, CEO of Bone Health Technologies. “There is a lack of safe, effective treatments for osteopenia, a condition that effects over 40 million Americans. It is exciting that CMS is supporting the efforts of companies working to solve these important unmet needs."

Another company likely to benefit is AppliedVR, which announced in October that its virtual reality headset had received breakthrough device approval as a treatment for fibromyalgia and chronic intractable low back pain.

“This new rule change means that Medicare recipients in need of pain relief will have access to our novel chronic pain therapy,” said Josh Sackman, co-founder and president of AppliedVR, who believes Medicare reimbursements will help speed up coverage of breakthrough devices by private insurers.  

“The MCIT rule change doesn’t directly impact coverage from commercial payers. They will continue to have their own standards for evidence and require new products to follow the existing evaluation process. However, the mandatory Medicare coverage will accelerate products getting into the market, where real world evidence will be collected on the value of those Breakthrough Devices,” Sackman explained in an email to PNN. 

“This data is extremely valuable for commercial payers to assess coverage. This should have a halo effect with payers that see the benefits of a breakthrough device in their Medicare book of business and may help them choose to expand coverage to their other lines of business, including commercial plans.”

Medicare coverage of a breakthrough device will initially be limited to four years. After the coverage period is over, CMS will reevaluate the devices based on clinical evidence of their effectiveness. Importantly, the four-year window also creates a revenue stream for manufacturers to continue improving their devices or invent new ones.

Skin Patch Reduces Pain Without Use of Drugs

By Pat Anson, PNN Editor

A drug-free skin patch that uses nanotechnology to help dial down pain levels provided significant relief to people living with arthritis, neuropathy and musculoskeletal pain, according to the results of a small study.

The Kailo pain patch contains billions of tiny nanoparticles made with copper, silver and silicon that help transmit electromagnetic signals from the nervous system. In theory, the nanoparticles act as a “bridge” over inflamed nerve pathways and restore their ability to transmit pain signals properly.

The patch is made by Utah-based Pain Relief Technologies, which claims in marketing material that its patented technology provides “natural relief anywhere on your body, in seconds.”

In the study, 66 patients wore the Kailo patch while continuing to take oral analgesic medications such as opioids and non-steroidal anti-inflammatory drugs (NSAIDs).

After 30 days, self-reported pain levels dropped significantly and 98 percent of patients said they reduced or stopped using oral medication. Their mood, sleep, walking ability, and other quality of life measures also improved.

The study findings, published in the journal Anesthesia and Pain Research, suggest that the analgesic effects of the Kailo patch are long lasting. About one in every four patients said their pain did not return after the patch was removed. Over half said it took at least a day for the pain to resume.

CLARITY SCIENCE IMAGE

“Modern science has allowed the incorporation of nanotechnology into topical patch systems, minimizing, and in the case of Kailo, eliminating the need for drugs/pharmacological agents. The interim results of this study are incredibly positive, and we look forward to providing the next phase of data that we have collected from patients with mild, moderate or severe pain,” lead investigator Jeffrey Gudin, MD, said in a statement.

Gudin was compensated by Clarity Science for conducting the study. You may recognize him from TV commercials for SalonPas, a rival pain relief patch.

An anesthesiologist by training, Gudin has become a prolific researcher, consultant and public speaker for dozens of companies involved in pain management, including Purdue Pharma, Salix, BioDelivery Sciences and Quest Diagnostics. He’s been paid over $1.5 million for his services since 2013, according to the OpenPayments database. In an email to PNN, Gudin said most of the money has been used for research and consulting on new analgesic therapies.

The Kailo patch is reusable and can be purchased without a prescription for $119. Reviews on Amazon for Kailo are mixed.

“Immediately upon placing it on my low back I could feel a warmth and my pain decreased rapidly. I was able to go to work the next day with relative comfort,” wrote one buyer who suffered pain from a hamstring injury.

“Did not reduce pain actually increased pain level,” said a disappointed user.

“Nothing else has worked for me but this significantly reduced my pain. It does not completely remove the pain, so don't expect that. But it reduced it enough that I can play with my kids, mow the lawn, work, essentially be a normal human being without medication,” said another user.

“I used it for a week, received no relief whatsoever,” wrote another buyer. “I am very dissatisfied and would like my money back.”

Topical Gel Shows Promise as Treatment for Neuropathic Pain

By Pat Anson, PNN Editor

An experimental gel developed to prevent skin damage caused by aging and ultraviolet light is showing promise as a treatment for chronic neuropathic pain, according to research underway in Australia.

The topical gel – known as RM191A – contains a copper-based compound that is absorbed by the skin and prevents the buildup of free radicals that cause skin damage associated with aging and skin cancer.

In a study recently published in the journal Redox Biology, RM191A was found to have potent antioxidant, anti-inflammatory and wound-healing properties in laboratory mice.

The gel is currently being evaluated in 24 patients at a Sydney hospital as a treatment for chronic nerve pain caused by surgery, chemotherapy, trauma and diabetes.  Results are expected later this month.

“Early sample uses of this topical formulation indicated it could be a significant in the management of certain types of chronic nerve pain,” says Llewellyn Casbolt, chief scientist and co-founder of Sydney-based RR MedSciences, which is developing the gel.

“In many ways, scientists see our discovery as a new class of anti-inflammatory that acts by the modulation of free radicals as well as reducing several inflammatory cytokines, providing a drug that can be therapeutically useful where the reduction of inflammation, as well as cellular and tissue healing - indeed pain relief - is also advantageous for a patient.”

The company plans to release an over-the-counter version of its gel in the next 12-18 months as a treatment for skin damage. It will take longer to get regulatory approval for the gel as a treatment for nerve pain and may require a prescription.

RR MedSciences (RRMS) plans to conduct further trials and is seeking additional partners and funding to accelerate the gel’s development.

“The management of pain, often related to conditions of inflammation or trauma that results in nerve or chronic pain is an area of great need.  Advancing the ability for people to modulate their pain, in a safe and effective manner that improves quality of life, is a core objective,” said Helena Libershal Casbolt, CEO and co-founder of RRMS.

A subsidiary of RRMS is currently selling a copper-based body cream called Blue Healer Care as a treatment for damaged skin and for relief from skin irritation and muscle soreness.

Why Water Soaking Works

By Forest Tennant, PNN Columnist

There is no medical treatment older than water soaking. It is legend and still works. Adhesive Arachnoiditis and other Spinal Canal Inflammatory Disorders (SCID’s) are particularly helped by water soaking – so much so that we consider it an essential treatment.

Why water soaking relieves pain has been a mystery until recent times. It is known that damaged or “dead” nerves won’t conduct  the body’s natural electric currents, so electricity backs up and is trapped or retained in body tissues. The result is more inflammation and pain “all over.”

Electricity has a negative charge and water tends to have a positive charge, so it pulls out excess electricity from the body, reducing inflammation and pain. If the water contains a mineral, it will pull out even more electricity. That is why mineral hot baths and Epsom Salts are so effective.

The lumbar-sacral spinal canal is loaded with nerve roots. They constantly conduct electric currents that go from the spinal cord to the legs, feet, bladder, sex organs and intestine.

Any damage, by any cause, to the spinal canal nerve roots causes a backup of electricity which is painful and produces even more inflammation. To prevent disease progression, daily water soaking can be most helpful.

Types of Water Soaking

You don’t have to have a jacuzzi or pool to do water soaking. A bathtub is great, but most of us take showers. When you shower, keep the water as hot as you can stand, and massage and stretch your back muscles as the hot water runs over your back. Soaking for 10 to 15 minutes in a jacuzzi, pool or bathtub is preferable, but hot showers morning and night is about as good.

Don’t forget the Epsom Salts. The body normally excretes its excess electricity into the air, mainly through nerve ends in the hands, head and feet. Foot soaking, particularly with Epsom Salts or other herbal salts, is an age-old remedy that attracts the electric currents that travel down the sciatic and other leg nerves.

Another soaking technique is a warm, water-soaked towel or other wet wrap placed over the lower back for 5-10 minutes. Remember, water soaking isn’t an “all wet” idea.

Forest Tennant is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Arachnoiditis Research and Education Project . Readers interested in subscribing to the  bulletins should send an email to tennantfoundation92@gmail.com.

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

Exercise Is Best Treatment for Low Back Pain, But Why?

By Pat Anson, PNN Editor

There has long been a consensus that the best way to treat chronic lower back pain (CLBP) – the world’s leading cause of disability – is by staying active and exercising. But a new study by Australian researchers failed to identify precisely why exercise is beneficial.

“A lot of treatments have stemmed from studies for people with CLBP, but the one with the most consistent evidence of benefit is exercise,” says senior author Matt Jones, PhD, an exercise physiologist, clinician and researcher at the UNSW Sydney School of Medical Sciences. “Despite decades of research in the area and more than 100 studies we analysed in our review, we still do not have a good idea of why exercise might be effective for CLBP.”

Jones and his colleagues recently reported their findings in the journal Musculoskeletal Science and Practice. They reviewed 110 research papers on CLBP conducted in Australia, United States, China, Brazil and Europe, and found little agreement on why researchers thought exercise relieved lower back pain.

“Researchers proposed common reasons as to why exercise was beneficial, including improvements in fitness – for example, core stability, aerobic fitness – and improvements in mood and confidence,” Jones said. “But the effects of these proposed reasons on outcomes for people with CLBP were seldom examined in the papers.

“There have been trends in research over time, where everyone focuses on a ‘flavour of the month’ – like motor control or McKenzie therapy, for example – but because the effects of exercise are broad and it impacts on many different systems in the human body, it’s difficult for researchers to pinpoint exactly why they think it might be benefiting people with pain.”

At any given time, over 500 million people worldwide are suffering from CLBP, which is “non-specific” back pain lasting three months or longer – not the severe back pain caused by degenerative disc disease, spinal injuries, arthritis and other chronic conditions. CLBP mostly affects adults of working age in lower socioeconomic groups, who often have physically demanding jobs.

A 2018 review published in The Lancet by an international team of researchers found that CLBP is often treated with bad advice, inappropriate tests, risky surgeries and painkillers. The authors said there was limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) were not recommended at all.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Professor Rachelle Buchbinder of Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

Jones said the aggressive treatments may not work because they don’t address underlying psychological reasons for back pain.

“Chronic pain is tricky and there are a lot of factors that can contribute to it – so, it's not simply biological aspects of tissue damage, but there are psychosocial elements at play, as well things like a person’s mood or confidence in their own abilities to do something,” he said. “Today’s evidence suggests CLBP likely comes from the brain and nervous system being a bit over-protective and generating a pain response – despite no obvious physical damage to the body.”

Although his review did not address what specific exercises were most effective for CLBP, Jones and his team recommended 33 “mechanisms” that people can use to relieve back pain, such as building muscle strength and flexibility or through social support and coping strategies.

“Many scientists have investigated this question before and the short answer is, there are no specific exercises recommended to alleviate CLBP,” he said. “But there are literally hundreds of studies on exercise for people with chronic pain, not only CLBP, and researchers consistently find exercise is one of the most effective treatments – it might not cause huge reductions in pain and disability, but it does help.”

Vibrating Belt Gets FDA ‘Breakthrough Device’ Designation for Osteoporosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has given “Breakthrough Device” designation to a vibrating belt that lowers the risk of bone fractures caused by osteoporosis. When worn around the waist, the OsteoBoost Vibration Belt delivers gentle stimulation to the hips and spine, simulating the effects of exercise and strengthening bones.

Osteoporosis is caused by the loss of bone mineral density (BMD) and is one of the most common health conditions associated with old age. More than 10 million Americans suffer from osteoporosis and 43 million have its precursor, osteopenia.

About 1 in 2 women and 1 in 4 men over the age of 50 will suffer an osteoporosis-related fracture, usually in their hip or spine. Breaking a bone is especially traumatic for the elderly and can lead to a cascade of health problems, including chronic pain, disability and early death.

Osteoporosis is currently treated with changes in diet, exercise and bisphosphonate drugs such as Fosamax, which slow the loss of BMD. However, long term use of bisphosphonates can lead to side effects such as bone, muscle or joint pain, as well as nausea and heartburn.

“For years, I have wanted a better option for my patients with low bone density that doesn’t have the potential side effects and the inconvenience of current drug treatments. With OsteoBoost we’ve created a safe, drug-free alternative that is easy and convenient. Now my patients with osteopenia have a new way to improve their bone health and reduce their risk of fracture,” says Dr. Shane Mangrum, co-founder of San Francisco-based Bone Health Technologies, which makes the OsteoBoost belt.

OsteoBoost uses whole body vibration (WBV) technology originally developed for NASA to improve the bone health of astronauts in a weightless environment. Here on earth, WBV has been found to improve bone mineral density, but it requires users to stand on a stationary vibrating platform, which isn’t always practical.

Because OsteoBoost is wearable, users can go for a walk or perform simple household chores while getting treatment. It’s recommended the device be used in 30-minute sessions, 3 to 5 times a week.

In a small clinical trial, OsteoBoost reduced bone loss in postmenopausal women by an average of 14%, a reduction similar to bisphosphonates. The National Institutes of Health is funding a larger, $2 million study of OsteoBoost that is currently enrolling postmenopausal patients. It is scheduled to be completed in early 2022.

If that study is successful, the FDA’s Breakthrough Device designation will speed up the agency’s review of OsteoBoost and help bring it to market sooner. The belt is not currently available for purchase and will require a a prescription when it is.

A 2011 Canadian study found that WBV did not improve bone mineral density in postmenopausal women who used a vibrating platform daily for a year while also taking vitamin D and calcium supplements.

"Although commercially available WBV devices are marketed to and used by patients, the beneficial effects of WBV on fracture risk and BMD have not been established, and recent randomized, controlled trials in postmenopausal women have shown conflicting results," said lead researcher Angela Cheung, MD, at University Health Network in Toronto. "Women would be farther ahead in making sure that they are exercising regularly and eating nutritious foods."