EaseVRx utilizes cognitive behavioral therapy and other behavioral therapy techniques.
The US Food and Drug Administration has authorized the marketing of a new prescription-use immersive virtual reality system for chronic pain reduction called EaseVRx.
The approval allows AppliedVR to move forward with the platform that utilizes cognitive behavioral therapy and other behavioral methods to reduce pain in adult patients with chronic lower back pain.
The virtual reality platform uses the principles of CBT and other behavioral therapy techniques for pain reduction and pain interference. Intended for at-home self-use, EaseVRx consists of a headset, controller, and a Breathing Amplifier that directs the users breath toward the headset’s microphone for deep breathing exercises.
The VR program addresses the physiological symptoms of pain and aids in pain relief through a skills-based treatment program that includes 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 platform includes 56 sessions between 2-16 minutes long over a daily 8 week program.
The approval was based on the results of a randomized, double-blinded clinical trial involving 179 patients with chronic lower back pain. Each participant was assigned to either the EaseVRx immersive 3D program or a control 2D program that did not utilize skills-based CBT methods of treatment.
Each patient was followed for 8.5 months, including a 2-week baseline assessment period, an 8 week VR program, a post-treatment assessment, and a follow-up at 1, 2, 3, and 6 months following completion of the program.
At the conclusion of the study, 66% of EaseVRx users reported a greater than 30% reduction in pain, compared to 41% of the control group. In addition, 46% of EaseVRx users reported a greater than 50% reduction in pain, compared to 26% of the control group.
At the end of the 1-month follow-up, the EaseVRx group continued to report a 30% reduction in pain, which remained at 2 and 3 months for all measures other than pain intensity.
EaseVRx was previously granted Breakthrough Device designation.
“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.”