The FDA authorized a prescription immersive virtual reality (VR) system, EaseVRx, to help manage pain in adult patients with chronic lower back pain.
The device—which is intended for at-home use and consists of a VR headset, a controller, and a “Breathing Amplifier” attached to the headset that directs a patient’s breath to the headset’s microphone in order to facilitate deep breathing exercises—utilizes the principles of cognitive behavioral therapy and other behavioral therapy techniques in order to reduce pain.
“The device’s VR program uses established principles of behavioral therapy intended to address the physiological symptoms of pain and aid in pain relief through a skills-based treatment program,” the FDA explained. “These principles include 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.”
The VR treatment program is delivered over the course of 56 sessions that are between 2-16 minutes in length and intended for use as part of a daily eight-week treatment program, the agency noted. Each session “incorporates elements of the aforementioned principles to provide the user with skills to achieve relief and reduction in the interference of pain in daily activities.”
“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a statement. “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.”
This authorization was based on findings from a randomized, double-blind clinical study in which 179 patients with chronic lower back pain were randomized to either the EaseVRx 3-D program or a control 2-D program that didn’t include CBT. Patients were followed for 8.5 months, including a two-week baseline assessment, the eight-week VR program, post-treatment assessment, and follow-up at one, two, three, and six months post-completion.
At the end of the eight-week treatment program, participants were asked to rate their pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep, and pain interference on stress on a 10-point scale, with 10 being the most severe.
“At the end of treatment, 66% of EaseVRx participants reported a greater than 30% reduction in pain, compared to 41% of control participants who reported a greater than 30% reduction in pain,” the FDA wrote. “Furthermore, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared to 26% of control participants. At one-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain and at the two- and three-month follow-up marks, the 30% reduction in pain remained for all outcomes with the exception of pain intensity. In contrast, the control group reported a reduction in pain below 30% at one-, two-, and three-month follow-up for all outcomes.”
Patients experienced a decrease in pain intensity of around 1.31 points over the course of the eight-week program, as well as a decrease in pain interference for all measured outcomes ranging from 0.95-1.27 points from the respective scores at baseline. No serious adverse events were reported, though roughly 20.8% of participants reported discomfort with the VR headset and 9.7% reported motion sickness and nausea.
EaseVRx is manufactured by AppliedVR.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 725
Topic ID: 88,725,393,730,192,725,925
