FDA Designates First Virtual Reality Device for Chronic Pain

By Pat Anson, PNN Editor

AppliedVR, a Los Angeles-based virtual reality company, has announced that its EaseVRx headset has received Breakthrough Device Designation from the Food and Drug Administration for treating fibromyalgia and chronic intractable low back pain.

EaseVRx is the first virtual reality (VR) device to get a Breakthrough Designation from the FDA for treating a chronic pain condition. The designation speeds up the development and review of new medical devices that treat life-threatening or irreversibly debilitating diseases or conditions. It could also speed up insurance coverage of VR therapy for chronic pain.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” Matthew Stoudt, CEO and co-founder of AppliedVR, said in a statement.

“Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.” 

AppliedVR funded a recent clinical trial that showed VR therapy can be self-administered at home to treat chronic pain. Patients living with fibromyalgia or chronic lower back pain were given VR headsets and instructed to watch at least one virtual reality program daily for 21 days.

The programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is to help patients learn how to manage their pain and other symptoms by distracting them and making their pain seem less important

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy. Their pain intensity was reduced an average of 30 percent. Physical activity, mood, sleep and stress levels also improved.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Beth Darnall, PhD, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

PNN columnist Madora Pennington, who lives with chronic pain from Ehlers-Danlos Syndrome, recently reviewed one of AppliedVR’s headsets. She said watching VR programs helped calm and relax her.

“The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to,” Madora wrote. “After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.”

AppliedVR’s technology is being used in hundreds of hospitals, but is not expected to be available for home use until next year. The company is working with Geisinger Health and Cleveland Clinic on two studies to see if VR therapy can be used as an opioid-sparing tool for acute and chronic pain.

VR for Phantom Limb Pain

Virtual reality technology received another boost this week when the Department of Defense awarded Chicago-based Coapt a $2.3 million grant to develop virtual reality therapies for phantom limb pain. Wounded veterans and amputees who have lost arms or legs often suffer from nerve pain and other sensations from their missing limbs.

"Phantom limb pain is a serious and persistent challenge for many upper and lower-limb amputees, and new, technology-based therapies have incredible promise," Blair Lock, co-founder and CEO of Coapt, said in a statement. "Preliminary work has shown that VR-based, actuated therapy can manage pain more effectively and have lasting effects. This grant will allow us to further study this therapy and bring to market a solution for those suffering from phantom limb pain in a way that also happens to be engaging."

Coapt has previously developed a VR-based therapy to help upper-limb amputees improve control of their prostheses. The technology also shows promise as a treatment for phantom limb pain. Coapt will use the grant money to further study the effectiveness of VR therapy and create a commercially viable product for both civilians and veterans with upper and lower-limb amputations.

Study Finds Microdosing THC Reduces Pain Levels

By Pat Anson, PNN Editor

Very low doses of inhaled THC – the psychoactive ingredient in cannabis – can significantly reduce pain levels in chronic pain patients, according to a small study conducted in Israel.

The concept of “microdosing” cannabis isn’t new, but this was the first clinical study to demonstrate its effectiveness in temporarily relieving pain. The study was sponsored by Syqe Medical, an Israeli medical technology company that makes an inhaler designed to deliver microdoses of cannabis and other drugs.

The study involved 27 patients living with neuropathy, radiculopathy, phantom limb pain or Complex Regional Pain Syndrome (CRPS), who self-reported pain levels of at least 6 on a zero to 10 pain scale. Participants were randomly assigned to three groups that inhaled either a placebo or two different microdoses of THC.  

The most effective dose to relieve pain was just 500 micrograms of THC, inhaled 3-4 times per day. Participants reported a 2 to 3 point reduction in their pain levels for 150 minutes.  

A typical cannabis patient might consume 150,000 micrograms of THC per day – about 75 times more than the highest dose used in the study. Researchers say their findings, published in the European Journal of Pain, suggest that pain patients can benefit from dramatically lower doses.

"We can conclude from the study results that low doses of cannabis may provide desirable effects while avoiding cognitive debilitations, significantly contributing to daily functioning, quality of life, and safety of the patient,” said lead researcher Elon Eisenberg, PhD, Director of the Multidisciplinary Pain Relief Unit at Rambam Health Care Campus in northern Israel.

“The doses given in this study, being so low, mandate very high precision in the treatment modality. This precision is unique to the Syqe drug delivery technology, enabling cannabis dosing at pharmaceutical standards."

There were side effects from inhaling microdoses of THC. About 20% of patients reported feeling “high” or experienced dizziness, sleepiness, nausea, cough or dry mouth. But researchers said there was “no evidence of consistent impairment” in any of the participants.

The risk of impairment from THC is one reason researchers and cannabis companies have largely focused on the medical benefits of cannabidiol (CBD), a compound also found in marijuana. CBD is not psychoactive, while THC can make people impaired – at least in high doses.

"This study is the first to show that human sensitivity to THC is significantly greater than previously assumed, indicating that if we can treat patients with much higher precision, lower quantities of drug will be needed, resulting in fewer side effects and an overall more effective treatment,” said Perry Davidson, CEO of Syqe Medical.

“The Syqe drug delivery technology is also applicable to opioids and other compounds that, while potentially effective, are notoriously associated with dangerous side effects. The introduction of a tool to prescribe medications at such low doses with such high resolution may allow us to achieve treatment outcomes that previously were not possible."

In addition to cannabis, the company is also exploring the use of its inhaler to deliver other drugs for treating pain, sleep, anxiety and cancer. The Syqe inhaler is sold in Israel by Teva Pharmaceuticals. Approval is also being sought to begin sales in Europe, Canada and Australia. Syqe is planning to submit a medical device application to the Food and Drug Administration in the United States.

Experimental Treatment Targets Neuropathic Pain

By Pat Anson, PNN Editor

Researchers in Denmark have developed a promising new compound to treat neuropathy that targets the hyper-sensitized nerves that cause chronic pain. The experimental compound – a peptide called Tat-P4-(C5)2 -- has only been tested in mice, but researchers hope to begin clinical trials on humans soon.

"We have developed a new way to treat chronic pain. It is a targeted treatment. That is, it does not affect the general neuronal signaling, but only affects the nerve changes that are caused by the disease," says Kenneth Lindegaard Madsen, PhD, Associate Professor at the University of Copenhagen.

"We have been working on this for more than ten years. We have taken the process all the way from understanding the biology, inventing and designing the compound to describing how it works in animals, affects their behaviour and removes the pain.”

Madsen and his colleagues recently published their findings in the journal EMBO Molecular Medicine .

The image below shows the compound Tat-P4-(C5)2 after it is injected into the spinal cord. The compound (purple) penetrates the nerve cells of the spinal cord (yellow), but not the surrounding cells (the cell nuclei are blue). The compound blocks neuropathic pain signals – the kind associated with diabetic neuropathy, shingles, phantom limb pain and chemotherapy-induced pain — from being sent to the brain.

UNIVERSITY OF COPENHAGEN

In a previous study, the researchers showed in an animal model that use of the compound can also reduce tolerance and the risk of addiction. They believe the compound will be more effective and safer than the anti‐convulsants, antidepressants and opioid medications now used to treat neuropathy.

"The compound works very efficiently, and we do not see any side effects. We can administer this peptide and obtain complete pain relief in the mouse model we have used, without the lethargic effect that characterises existing pain-relieving drugs," said Madsen.

"Now, our next step is to work towards testing the treatment on people. The goal, for us, is to develop a drug, therefore the plan is to establish a biotech company as soon as possible so we can focus on this."

Help Us Get Our Lives Back

By Andrea Giles, Guest Columnist

I am a 49-year old disabled nurse living in Wyoming. Since 2010, I have been diagnosed with ankylosing spondylitis, phantom limb pain and severe osteoarthritis with multiple major joint deformities.  My remaining knee is now bone on bone, requiring me to use a wheelchair. 

I lost my right leg and half of my pelvis after a total hip replacement due to the osteoarthritis, after which I developed a severe MRSA bacterial infection that resulted in the total hip disarticulation. I’ve had horrible phantom limb pain since the amputation. I also had 2 failed spinal fusions, leaving me with chronic back pain and nerve damage. Since 2010, I have had a total of 52 surgeries.

From 2010 to 2016, I was treated with opioid medication by a pain management physician, with a stable, safe, effective and legal regimen. I followed all of the requirements, such as urine drug tests, pill counts, using the same pharmacy, etc.

Then, at an appointment in 2016, my physician told me that because of the CDC guidelines, he would no longer prescribe opioid medication to me. I was forced off my high dose (120MME) cold turkey. I was lucky, as I didn’t experience withdrawal symptoms other than the reappearance of severe, intractable pain.

I tried to use NSAIDS for the pain and developed a severe, life threatening reaction to them called Stevens-Johnson Syndrome. I came very close to death and was in intensive care for 6 weeks. Because of that, I will be unable to take NSAIDs for the rest of my life.

Because of the MRSA infection, no physician will perform any further surgeries or steroid injections on me because of the risk of activating another infection.

I have tried acupuncture, massage, chiropractic therapy, mirror therapy, physical therapy, water therapy, many different herbal and nutritional supplements, aromatherapy, music therapy, psychotherapy, hypnotherapy and mindfulness. All without relief of the severe, intractable pain.

When I was forced off opioids, I also lost my career as a very good ER nurse. I went from a functional member of society to a home-bound, miserable person who hurts too badly to keep my house clean like I always prided myself on. Many days I’m in too much pain to even shower or complete daily activities of living.

My husband and children have lost the wife and mother they were able to interact with, go places with, share activities with, everything. I have gained 50 pounds because the pain has left me unable to exercise.

After I stopped taking opioids, I developed hypertension.  Before, my blood pressure had never been higher than 130/80. Now I take medication for high blood pressure and it is still usually around 150/90.

I also developed heart arrhythmia and last year suffered 2 sudden cardiac arrests. I only survived because both times they were witnessed by my husband, who is also an ER nurse, so he immediately started CPR. The cardiologist could find no underlying causes and told me that the arrhythmia and cardiac arrests were probably due to longstanding, untreated severe pain.

There is no physician that I can find that will accept me as a chronic pain patient and my primary care doctor refuses to prescribe opioids anymore. I have literally tried every pain management physician in Wyoming and in Montana, which would have required a 6 to 7-hour drive for each appointment.

I, along with many other intractable pain patients, are working feverishly contacting our congressional representatives, federal government and civil rights groups, begging for help -- for anyone in a position of power to hear our cries of medical abandonment and neglect.

Our pleas mostly fall on deaf ears, as the government has convinced the media and the public that pain patients are all addicts and use opioids only to get high. They site false overdose statistics and refuse to acknowledge that while opioid prescriptions have declined -- causing devastating effects on the pain community -- the overdose rate continues to climb because the clear majority of overdoses are due to heroin, illicit fentanyl or polypharmacy with multiple drugs.

Many intractable pain patients are committing suicide because untreated pain takes away their quality of life and the will to live – something they had with legally prescribed and effective doses of opioid medication.

We are desperate. We don’t want to get high. We just want to make informed decisions with our physicians about our own healthcare, to regain access to opioid medication, and to get our lives back!

Andrea Giles lives in Wyoming with her family.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Cellphone Towers Amplify Pain in Amputees

By Pat Anson, Editor

For many years there has been a debate about the possible health effects of cell phone towers, power lines and other transmission devices that create electromagnetic fields (EMFs). These magnetic and electromagnetic frequency waves pass right through us, raising concern that they might cause cancer and other adverse health effects.

A new study by researchers at The University of Texas at Dallas suggests that cellphone towers may trigger neuropathic pain, especially in amputees that suffer from phantom limb pain.

"Our study provides evidence, for the first time, that subjects exposed to cellphone towers at low, regular levels can actually perceive pain," said Dr. Mario Romero-Ortega, senior author of the study and an associate professor of bioengineering in the University's Erik Jonsson School of Engineering and Computer Science. "Our study also points to a specific nerve pathway that may contribute to our main finding."

Most of the previous research into the possible health effects of cellphone towers has been conducted on individuals with no diagnosed, pre-existing conditions. This is one of the first studies to look at the effects of EMFs on amputees.

For years, retired Maj. David Underwood noticed that whenever he drove under power lines or near other electromagnetic fields, he would feel a buzz in what remained of his left arm. When traveling by car through Texas' open spaces, the buzz often became more powerful.

"When roaming on a cellphone in the car kicked in, the pain almost felt like having my arm blown off again," said Underwood, an Iraq War veteran who was injured by an improvised explosive device (IED). His injuries resulted in 35 surgeries and the amputation of his left arm.

"I didn't notice the power lines, cellphones on roam or other electromagnetic fields until I first felt them in my arm," says Underwood.

After learning about Underwood’s experiences, Romero-Ortega decided to study the phenomena.

He and his colleagues thought that neuromas -- inflamed peripheral nerve bundles that often form due to injury – could be more sensitive to EMFs. To test their theory in a laboratory, they assigned 20 rats into two groups -- one receiving a nerve injury that simulated amputation, and the other group receiving a sham treatment.

Researchers then exposed the rats to a radiofrequency electromagnetic antenna for 10 minutes, once per week for eight weeks. The antenna delivered a power density similar to what a human would be exposed to 125 feet away from a cellphone tower.

By the fourth week, 88 percent of the rats in the nerve-injured group demonstrated a behavioral pain response, while only one rat in the sham group exhibited pain. After growth of neuroma and resection -- the typical treatment in humans with neuromas who are experiencing pain -- the pain responses persisted.

"Many believe that a neuroma has to be present in order to evoke pain. Our model found that electromagnetic fields evoked pain that is perceived before neuroma formation; subjects felt pain almost immediately," Romero-Ortega said. "My hope is that this study will highlight the importance of developing clinical options to prevent neuromas, instead of the current partially effective surgery alternatives for neuroma resection to treat pain."

Romero-Ortega says since the research produced pain responses in rats similar to those in anecdotal reports from humans such as Major Underwood, the results "are very likely" generalizable to humans.

"There are people who live in caves because they report to be hypersensitive to radiomagnetism, yet the rest of the world uses cellphones and does not have a problem. The polarization may allow people to disregard the complaints of the few as psychosomatic," he said. "In our study, the subjects with nerve injury were not capable of complex psychosomatic behavior. Their pain was a direct response to man-made radiofrequency electromagnetic energy."

At one point in the study, members of the research group showed Underwood video of subjects in the experiment and their response to radiofrequency electromagnetic fields.

"It was exactly the same type of movements I would have around cellphones on roam, power lines and other electromagnetic fields," said Underwood.

Until the study was published online in PLOS ONE, there was no scientific evidence to back up the anecdotal stories of people like Underwood, who reported neuropathic pain around cellphone towers and other technology that produce EMFs. .

Phantom limb pain is a common and painful disorder that many amputees feel after their limbs are removed. The origin of the pain and sensations from the missing limb are not well understood. There are nearly 2 million amputees in the United States, according to the Centers for Disease Control and Prevention.