FDA Authorizes EaseVRx Virtual Reality System To Reduce Chronic Pain
The U.S. Food and Drug Administration has authorized marketing of virtual reality or VR system, EaseVRx, to reduce chronic pain.
EaseVRx, manufactured by AppliedVR, is a prescription-use immersive VR system that uses principles of cognitive behavioral therapy or CBT and other behavioral methods for the purpose of reduction of pain and pain interference. The system helps with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.
The prescription device is intended for at-home self-use. It consists of a VR headset and a controller, along with a “Breathing Amplifier” attached to the headset that directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises.
The device’s VR program addresses the physiological symptoms of pain and aid in pain relief through a skills-based treatment program, which consists of 56 VR sessions that are 2-16 minutes in length.
This is in comparison to current treatment plans for chronic lower back pain that often include prescription and over-the-counter pain medications, exercise, steroid injections, surgery and transcutaneous electrical nerve stimulation, among other options.
For the approval, the regulator evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain. The participants were assigned to one of two eight-week VR programs: the EaseVRx immersive 3-D program or a control 2-D program that did not utilize skills-based CBT methods of treatment.
At the end of treatment, 66 percent of EaseVRx participants reported more than 30 percent reduction in pain and 46 percent, more than 50 percent reduction in pain, compared to 41 percent and 26 percent, respectively, of control participants.
In the follow-up period also, EaseVRx group participants continued to report improved results compared to the control group. During the study, no serious adverse events were observed or reported.
EaseVRx was earlier granted Breakthrough Device designation, for which a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet certain criteria.
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