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NOVEMBER 5, 2020
Virtual Reality Device Gets FDA Approval for Fibromyalgia, Low Back Pain
Originally published in our sister publication, Pain Medicine News.
The FDA has granted breakthrough device designation to EaseVRx (AppliedVR) for the treatment of resistant fibromyalgia and chronic intractable lower back pain. The designation was based in part on a randomized controlled trial of the device evaluating the feasibility, efficacy and acceptability of virtual reality (VR)-based digital behavioral therapy for self-management of chronic pain at home.
The researchers, led by Beth Darnall, PhD, an associate professor of anesthesiology and perioperative and pain medicine at Stanford University’s School of Medicine in Palo Alto, Calif., cited a need in the clinical literature for research on skills-based VR behavioral programs for chronic pain populations (JMIR Form Res 2020;4[7]:e17293).
To that end, 97 adults (age range, 18-75 years) with self-reported chronic nonmalignant low back pain or fibromyalgia (average pain intensity >4 in the past month and chronic pain duration exceeding six months) were randomly assigned, unblinded, to either 21 days of skills-based VR (n=39) or an audio-only version of the 21-day VR program (n=35). A total of 1,067 sessions were conducted in the VR group and 1,048 in the audio group.
High levels of satisfaction in the VR group (24/29 [83%], compared with 26/33 [72%] in the audio program) and a favorable side-effect profile (six subjects in the VR group reported nausea or motion sickness) “support the feasibility and acceptability of at-home, skills-based VR for chronic pain,” the authors concluded. They cited clinically significant reductions (30% or better) that strengthened over time in several pain measures (pain intensity, pain-related activity interference, pain-related mood interference, pain-related sleep interference and pain-related stress interference) over the course of the 21-day treatment, both in the VR group and compared with the audio-only version.
AppliedVR, which was also shown to effectively treat acute pain in hospital settings (JMIR Ment Health 2017;4[1]:e9), will be the subject of two National Institutes of Health–funded clinical trials to study VR as an opioid-sparing tool for acute and chronic pain.
—AN Staff