FDA https://www.fda.gov has authorized marketing of EaseVRx, a prescription-use immersive Virtual Reality (VR) system. The system uses cognitive behavioral therapy and other behavioral methods to help reduce pain in patients 18 years and older with diagnosed chronic lower back pain.
Christopher M. Loftus, MD., Acting Director, Office of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health reports, “Pain reduction is a crucial component of living with chronic lower back pain. FDA’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.”
Current treatment plans for chronic lower back pain can include prescription and over-the-counter pain medications, exercise, steroid injections, surgery, transcutaneous electrical nerve stimulation, plus Cognitive Behavioral Therapy (CBT) may also be used to reduce chronic pain.
EaseVRx system uses the principles of CBT and other behavioral therapy techniques to help reduce the pain. The prescription device intended for home self-use, consists of a VR headset and controller along with a “Breathing Amplifier” attached to the headset directing a patient’s breath toward the headset’s microphone for use in deep breathing exercises.
The device’s VR program uses established principles of behavioral therapy that include deep relaxation, attention shifting, and interoceptive awareness. The EaseVRx treatment program consists of 56 VR sessions which are used as part of a daily eight week treatment program.
FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double blinded clinical study of 179 participants with chronic lower back pain that were assigned to one of two eight week VR programs.
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 greater than 30% reduction in pain.
Go to https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-virtual-reality-system-chronic-pain-reduction for more information.