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Business & Regulation Technology and Equipment, Digital Technologies, Standards & Regulation

FDA Authorizes VR for Pain Reduction

The FDA has given authorization to AppliedVR to market their virtual reality system, EaseVRx, as a prescribed treatment option for chronic lower back pain. Chronic lower back pain is defined as moderate to severe pain lasting more than three months – and is one of the most common chronic pain conditions in the US.

EaseVRx is self-administered by patients and takes them through a series of once-daily modules (lasting 2–16 minutes) that present concepts and techniques based on cognitive behavioral therapy, mindfulness, and biofeedback – including “deep relaxation, attention-shifting, interoceptive awareness – the ability to identify, access, understand and respond appropriately to the patterns of internal signals – and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation.”

It is designed to be used as part of a daily, eight-week treatment program.

The system comprises a VR headset, controller, and a breathing amplifier for use in deep breathing exercises. It is designed to be used as part of a daily, eight-week treatment program.

In a statement, Christopher M. Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, explained that the 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 FDA decision is based on the review of a clinical study where participants were assigned to one of two eight-week VR programs: the EaseVRx program or a control program. Around 46 percent of EaseVRx participants reported a greater than 50 reduction in pain compared with 26 percent of control participants. The EaseVRx group also continued to report a reduction in pain at two- and three-month follow ups. The study results have been published and can be reviewed online.

EaseVRx received breakthrough device designation in October 2020 and was reviewed through the FDA’s De Novo premarket review pathway, which assesses new devices that have a low-to-moderate risk. That said, it seems virtually(!) impossible to avoid side effects; some study participants reported discomfort with the headset and/or motion sickness.

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