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FDA Approves VR Treatment for Chronic Lower Back Pain

Analysis  |  By Eric Wicklund  
   November 18, 2021

Healthcare providers will soon be able to prescribe a virtual reality treatment that uses cognitive behavioral therapy to help patients manage their lower back pain.

Federal regulators have approved a prescription-based virtual reality platform designed to help people manage pain.

The US Food and Drug Administration this week authorized the marketing of AppliedVR’s EaseVRx product, which uses cognitive behavioral therapy (CBT)  and an immersive VR platform to help patients manage chronic lower back pain. The treatment, designed as a prescription for at-home use, consists of a VR headset, controller, and “breathing amplifier” that attaches to the headset and guides the user through breathing exercises.

“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 Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release issued by the FDA. “Pain reduction is a crucial component of living with chronic lower back pain. 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.”

The agency’s action continues a slow and steady advance for digital therapeutics, or digital health tools and platforms designed to support clinical treatment, in many cases replacing in-person services or even medications. Advocates say these tools can improve access to care for patients at home and help reduce the nation’s ongoing opioid abuse epidemic.

The treatment consists of 56 VR sessions of between two and 16 minutes in length, part of an eight-week regimen that includes behavioral therapy and is designed to give the user skills to “achieve relief and reduction in the interference of pain in daily activities.”

The FDA’s approval is based on a study of roughly 180 people living with chronic lower back pain who were assigned either the EaseVRx program or a control 2-D program that didn’t include skills-based CBT treatment. After an almost nine-month period that included baseline assessment, eight weeks of therapy and follow-up assessments, two-thirds of the EaseVRx participants reported a reduction in pain greater than 30 percent, compared to 41 percent of the control group, and 46 percent of the EaseVRx participants reported a reduction in pain of more than 50 percent, compared to 26 percent of the control group.

AppliedVR executives say the platform also reduces sleep interference and stress, improves mood and offers a high level of patient engagement, with more than 90 percent of those in the study seeing the program through to its end.

FDA officials say there were no adverse events associated with using the technology, though about 20 percent reported discomfort with the headset and about 10 percent experienced motion sickness and nausea.

Driven by the popularity of AR and VR technology in gaming, health systems have been experimenting with the technology for years, particularly in treatments that involve behaviors. This includes Cedars-Sinai in Los Angeles, which hosts an annual symposium on VR in healthcare.

Los Angeles-based AppliedVR, meanwhile, is partnering with the University of California at San Francisco on a business accelerator aimed at finding ways to use VR to improved access to care for underserved populations. And one of its chief competitors, Israel-based XRHealth, launched a handful of VR clinics last year where patients could be referred for VR therapy. 

Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.

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