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.

FDA Approves First Virtual Reality Device for Chronic Low Back Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has authorized the marketing of the first home-based virtual reality (VR) device for the treatment of chronic lower back pain in adults.

The EaseVRx headset uses guided VR programs to help patients relax, meditate and distract themselves from their pain, using the principles of cognitive behavioral therapy (CBT). The device is made by AppliedVR, a Los Angeles-based company that is developing therapeutic VR programs to help treat pain and other conditions.

"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," Christopher Loftus, MD, acting director of the FDA’s Office of Neurological and Physical Medicine Devices, said in a statement. “Today's authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain."

Chronic lower back pain is defined as moderate to severe pain in the lower back lasting longer than three months. It is one of the most common chronic pain conditions and a leading cause of disability.

The FDA’s marketing approval is based a clinical study of 179 participants with chronic lower back pain. Half were given an EaseVRx headset to watch immersive 3-D programs daily for 8 weeks. The other half also used the headset, but only watched routine nature scenes as a sham treatment.

APPLIEDVR IMAGE

At the end of treatment, 66% of those who watched VR programs reported at least a 30% reduction in pain, compared to 41% of participants in the sham control group.

Nearly half of those in the EaseVRx group reported at least a 50% reduction in lower back pain.

No serious adverse events were reported during the study. About 20% of participants reported discomfort with the headset and nearly 10% reported motion sickness and nausea.

EaseVRx was given a Breakthrough Device Designation by the FDA in 2020 for treating fibromyalgia and chronic lower back pain. The designation speeds up the development and review of new medical devices.

Marketing approval of EaseVRx – known as a "De Novo pre-market review" – creates a new regulatory classification for VR devices. It clears the way for similar devices with the same intended use to obtain marketing authorization – a significant development for the fledgling virtual reality industry.

"We worked tirelessly over the past few years to build an unmatched body of clinical evidence that demonstrates the power of VR for the treatment of pain, and couldn't be more thrilled to achieve this important milestone," said Josh Sackman, AppliedVR’s co-founder and president. "But, our mission does not stop with this one approval. We're committed to continuing research that validates our efficacy and cost-effectiveness for treating chronic pain and other indications."

EaseVRx will only be available by prescription. Its software programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.  The content also incorporates biopsychosocial pain education, diaphragmatic breathing, mindfulness, and relaxation exercises.

AppliedVR headsets are already being used for pain management in over 200 hospitals and healthcare systems. A company spokesman told PNN that EaseVRx will be available on a limited basis through select providers toward the middle of 2022, with a full commercial launch expected in 2023. AppliedVR's is currently building a distribution network and working with insurers -- Medicare, Medicaid and commercial -- to establish reimbursement levels. No pricing plans have been announced for its VR headset or programs.

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. 

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.

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.

Finding Pain Relief in a Virtual World

By Madora Pennington, PNN Columnist

I am sitting on a deserted beach in Tasmania, listening to the gently lapping waves. All my worries fade in just 3 minutes.

While on my couch, I am touring the famous sites of London. Have I been on vacation? I feel as if I have.

I am by a creek in Bavaria. Water gently crashes against the rocks. Leaves fall to the ground. In four minutes, I am in state of joy.

Underwater with a school of dolphins, twisting my head to get the best views as they swim above me and all around, I forget anything that bothers me, physical or mental.

How can I be in so many places? I am using a virtual reality program designed to relieve chronic pain. I love it. I look forward to doing it every day.

Later, when I am out and about, a sound I heard during my VR sessions, perhaps the swaying of a tree, makes my body relax without effort.

The AppliedVR headset I am using looks like a blacked-out snorkeling mask. It came with a warning not to expose it to direct sunlight, and to take great care not to scratch the lenses. The company loaned me the device to try at no cost and with no stipulations for this review.

Virtual reality (VR) had its start as entertainment in video gaming. Headsets have speakers or earphones, and are usually connected to a joystick or hand controller. When the user moves their head, tracking software shifts the images, providing an immersive experience into a full 360-degree view of a 3D world.

Besides gaming, VR has a growing number of practical uses. VR technology is used to teach dangerous jobs like piloting or to give doctors simulated practice at surgery. The U.S. military uses VR to train soldiers to fight and build mental resilience for battle. Ford employees use VR to inspect and look for problems in virtual automobiles before they are even manufactured. Architects and engineers use it to evaluate and find problems in their design work.

In a medical setting, VR therapy was first used in caring for patients who suffered burn wounds, which can be so painful that even opioids can be insufficient. A study found that VR, when coupled with pain medication, provided burn patients with significant relief.

More Than Just Distraction

How does VR make such a difference in pain?

“The most acceptable theory is the Gate theory of attention. It postulates that VR reduces the perception of pain by absorbing and diverting attention away from pain,” says Dr. Medhat Mikhael, a pain management specialist.

But there’s more to it. Dr. Brennan Spiegel, director of Cedars-Sinai's Health Service Research, completed a VR study on 120 hospitalized patients in 2019, which showed that VR significantly reduces pain. It was most effective for severe pain.

“Virtual reality is a mind-body treatment that is based in real science. It does more than just distract the mind from pain, but also helps to block pain signals from reaching the brain, offering a drug-free supplement to traditional pain management," Spiegel said.

Short-term, acute pain is a different beast than chronic pain. Only a few studies have been done using VR to treat chronic pain, which can overwhelm the nervous system, making the body even more sensitive to and aware of pain. This cycle can become so entrenched it can cause the body to interpret benign stimuli, such as the light brush of fabric against skin, as painful.

Early studies on VR for chronic pain are promising. In a study published in 2016, chronic pain patients had an average 60% reduction in pain from VR treatment. A third of the participants experienced total pain relief while doing VR sessions. They had a wide variety of conditions, such as spine pain, hip pain, myalgia, connective tissue disease, interstitial cystitis, chest pain, shoulder pain, abdominal pain and neuropathy. 

Another study recently found that VR reduces pain and improves mood and sleep in people living with fibromyalgia or chronic lower back pain.  

Pain Drifts Away

I’ve had a lifetime of chronic pain from the collagen disease, Ehlers-Danlos Syndrome. My body is very weak and flimsy. Having chronic pain and disability sometimes makes me feel resentful and betrayed by my own body.

In one VR session, I stare into the heavens. I am shown a projection of a human body and nervous system. A kind, encouraging woman explains simply and compassionately the phenomenon of pain. I hate my body less in two minutes.

Ordinarily, I would never play a video game. I don’t like cartoons. Meditating makes me anxious. I find it difficult to even lose myself watching a movie. I would not have thought I would respond well to virtual reality. But from the first brief session, I did.

I learned how to calm and balance my nervous system in an animated forest. Gently encouraged to breathe in time with a giant whimsical tree, the ground and surrounding plants change, becoming ever more colorful each time I exhale. The loving woman tells me I have changed myself and the outside world. I have to agree.

Some sessions are games that teach me to redirect my attention away from pain. In a cartoon winter wonderland, I shoot snowballs at happy teddy bears, who giggle when I hit them. I have made the teddy bears and myself happy.

In others programs, I swim with jellyfish. Or sunbathe on a beach in Australia. Or sit by a stream in the snowfall. You can watch a sample of these programs below.

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.

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.

VR reminds me of times in my life when I was fully engaged in the moment and overwhelmed by wonder or beauty. As a child swimming in the ocean, once I was surrounded by dolphins. They clicked and called to each other. I immediately forgot how cold I was and how my wet-suit was cutting off the circulation in my hands.

VR took me back to other transcendent moments of my life, like playing in an orchestra, surrounded by instruments producing layers of organized sound. Standing in front of Van Gogh’s Bedroom. A ride at Disneyland. Falling in love.

My only criticism of VR is the weight of the headset. The device is heavy and could be difficult for someone with neck or head pain to tolerate.

AppliedVR’s technology is being used in hundreds of hospitals, but it is not yet available for home use. The company hopes for a broader launch in 2021, but getting insurance coverage will be key.

"We know that living with and managing chronic pain can be a debilitating and costly challenge that is only exacerbated by the COVID crisis.  As such, we are focused on achieving our vision of delivering safe and effective VR therapeutics into the home where the need for non-opioid chronic pain treatment options is greatest,” says AppliedVR CEO Matthew Stoudt.

“We are now focused on partnering with payers to demonstrate how our chronic pain VR therapeutic improves health outcomes, reduces costs and empowers patients to lead their best lives.  This is the key to making VR a reimbursable standard of care for pain management."

In addition to pain, VR therapy is also being used to relax people going through dental procedures, chemotherapy, physical rehabilitation, phobias, anxiety and post-traumatic stress disorder (PTSD).

You cannot talk your brain out of perceiving pain, but with VR it finds other, better things to do than just focus on pain. Cognitive behavioral therapy and self-soothing techniques do that too, but VR disengaged my brain from the pain perception cycle at a much deeper level, just as pain once hijacked my thoughts and attention.

Madora Pennington writes about Ehlers-Danlos Syndrome and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Virtual Reality Therapy Can Reduce Chronic Pain at Home

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) can reduce chronic pain, improve mood and help people sleep, according to a small study of 74 patients living with fibromyalgia or chronic lower back pain.

The research, published online in JMIR-FR, is one of the first to look at the effectiveness of VR therapy when self-administered at home by chronic pain patients. It was funded by AppliedVR , a Los Angeles based company that is developing therapeutic VR content to help treat pain, depression, anxiety and other conditions.

“People with chronic pain often have limited access to comprehensive pain care that includes skills-based behavioral medicine. We tested whether VR that was self-administered at home would be an effective therapy for chronic pain,” said Beth Darnall, PhD, a pain psychologist who is AppliedVR’s chief scientific advisor.

“We found high engagement and satisfaction, combined with clinically significant reductions in pain and low levels of adverse effects, support the feasibility and acceptability for at-home, skills-based VR for chronic pain.”

Participants in the study were given VR headsets and instructed to have at least one session daily for 21 days. Half of the patients listened to audio-only programming, while the other half watched “virtual” programs in which they could swim with dolphins, play games or immerse themselves in beautiful scenery.

The programs are designed to help patients learn how to manage their pain and other symptoms by using cognitive behavioral therapy (CBT) to distract them and make their pain seem less important.

A sample of what they saw can be seen in this video:  

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy, which worked significantly better than the audio-only format in reducing five key pain indicators:

• Pain intensity reduced an average of 30%

• Physical activity improved 37%

• Mood improved 50%

• Sleep improved 40%

• Stress reduced 49%

Previous VR studies have had similar findings, but have largely focused on patients in hospitals and clinical settings. 

“This study is a fundamental step for advancing a clinically proven, noninvasive and safe digital therapeutic like VR for chronic pain, and demonstrates our platform is both viable and efficacious,” said Josh Sackman, co-founder and president of AppliedVR.

“Living with and managing chronic pain daily can be a debilitating and costly challenge, and many patients suffering from it can feel hopeless and desperate for any relief. So, as we engage in and accelerate more in-depth clinical research, we want them to know that we’re committed to making VR a reimbursable standard of care for pain.”

AppliedVR products are being used in hundreds of hospitals, but are currently only available to healthcare providers. The company recently partnered with University of California at San Francisco to study how VR therapy can improve patient care for underserved populations.

AppliedVR is also conducting two clinical trials to see if VR therapy can reduce the use of opioid medication for acute and chronic pain. The National Institute on Drug Abuse recently awarded nearly $3 million in grants to fund the trials.

The company is currently recruiting patients with chronic lower back pain for an 8-week trial of VR therapy. Headsets and other material will be mailed at no cost to participants at their homes. No in-person visits are required.