FDA Approves First Virtual Reality Pain Treatment

Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older. It is now the first FDA-approved, at-home, immersive virtual reality pain treatment for a chronic pain condition.

AppliedVR is focused on pioneering the next generation of immersive therapeutics for chronic pain. Prior to the FDA approval, the company’s EaseVRx received breakthrough device designation in 2020.

Immersive techniques use artificial or simulated environments to immerse users in their learning.

EaseVRx is a non-invasive, prescription-use virtual reality pain treatment that uses cognitive behavioral therapy (CBT) and other behavioral approaches to help patients achieve relief for back pain. It contains preloaded software content on a proprietary hardware platform that delivers automated behavioral skills content for pain treatment. This includes exercises, games and lessons designed to reduce pain, which include training in breathing, mindfulness exercises, executive functioning games, biopsychosocial pain education and relaxation exercises.

The immersive software is loaded onto a virtual reality headset and used by patients in sessions that range from two to 16 minutes in length. The self-administered virtual reality pain treatment system is designed for at-home use seven days a week for eight weeks.

The approval for the device comes after Los Angeles-based AppliedVR announced it had secured $36 million in a series B funding round earlier this month, which brings the company’s total funding to $71 million. The funding round included investments from F-Prime Capital, JAZZ Venture Partners, Sway Ventures and SVB Ventures.

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Chronic lower back pain is characterized by moderate to severe pain in the lower back that lasts longer than three months. It is one of the most common chronic pain conditions in the US and worldwide and is a major reason for missing work, according to Bone and Joint Initiative USA.

It is also an expensive burden on healthcare; when combined with neck pain treatments, it costs almost $77 billion to private insurers, $45 billion to public insurance and $12 billion in out-of-pocket costs for patients. A study from Johns Hopkins several years ago suggested that cumulatively, chronic pain can cost as much as $635 billion annually, which is more than the yearly costs of heart disease, diabetes and cancer combined.

Recent evidence shows that virtual reality is an effective tool for pain treatment. A study from Cedars-Sinai’s Health Service Research showed that virtual reality could alleviate pain in hospitalized patients. In addition, it can also be used to treat stress and depression.

How EaseVRx Virtual Reality Works

The EaseVRx virtual reality pain treatment system includes a VR headset, controller and a “Breathing Amplifier” attached to the headset, which channels the user’s breath toward the microphone on the headset for the deep breathing exercises. The VR program uses established behavioral therapy principles to target physiological symptoms of pain and delivers relief through behavioral skills-based treatment.

These principles include deep relaxation, attention-shifting, interoceptive awareness and aptly responding to the patterns of internal signals. It also involves perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization as well as knowledge of pain and rehabilitation. The system is for repeat use for a single patient, and is only effective for the treatment of chronic pain.

Chronic pain has significant negative impacts on mobility, daily activities and overall quality of life. Moreover, it has also been linked to anxiety and depression, poor perceived health and dependence on opioids. Conventional treatments for chronic lower back pain include prescription and over-the-counter medications, steroid injections, exercise, transcutaneous electrical nerve stimulation and surgery. Cognitive, emotional and behavioral approaches such as CBT can also be used to help convert negative thoughts and beliefs around pain and movement.

“Chronic low-back pain can be a debilitating and an incredibly costly problem, but now we’re one step closer to achieving our goal of making immersive therapeutics the standard of care for pain,” Matthew Stoudt, co-founder and CEO of AppliedVR, said in a press release.

Clinical Evidence for Virtual Reality Pain Treatment

The FDA approval for EaseVRx was based on data from two randomized control trials evaluating the efficacy of the VR-based system for at-home, self-administered treatment of chronic pain.

Both studies showed that the skills-based virtual reality pain treatment program improved multiple chronic pain outcomes, concluding that it was a “feasible and scalable way to treat chronic pain.”

The first study was published in JMIR Formative Research and analyzed data from individuals with chronic lower-back or fibromyalgia pain over a 21-day period. Participants using EaseVRx had significant reductions in five key pain indicators, as defined by a threshold of significance of 30 percent for each category.

In the second trial evaluating the safety and efficacy of EaseVRx over a period of eight weeks, patients that used EaseVRx reported significant improvements after treatment. This included a 42 percent reduction in pain intensity along with reductions in pain-related interferences in activity (49 percent), sleep (52 percent), mood (56 percent) and stress (57 percent).

AppliedVR is already being used across 200 health systems around the world, the company says. To date, approximately 60,000 patients have been treated with the VR system as part of pain management and wellness programs.

AppliedVR says it will continue testing the VR system to demonstrate both its clinical efficacy and cost-effectiveness to treat pain — for the latter, it plans to complete multiple health economics and outcomes (HEOR) studies with commercial payers. The company also has a collaboration with Geisinger and Cleveland Clinic for NIDA-funded clinical trials to evaluate VR as an opioid-sparing tool for acute and chronic pain.

Virtual reality treatment approaches for conditions including pain and depression are a growing area in medtech. In addition to AppliedVR, there are several other companies leveraging virtual reality technologies to treat chronic pain, including Tennessee-based BehaVR and XRHealth in Massachusetts among others.