WEDNESDAY, Nov. 17, 2021 (HealthDay News) -- A three-dimensional (3-D) virtual reality system to treat back pain was approved by the U.S. Food and Drug Administration on Tuesday. The EaseVRx system is a prescription device for at-home use that combines cognitive behavioral therapy (CBT) and other behavioral methods to treat patients 18 years and older with chronic lower back pain.
The EaseVRx system includes a virtual reality headset and controller and a "breathing amplifier" that directs a patient's breath toward the headset microphone for use in deep breathing exercises. The system uses a number of CBT methods to achieve pain relief, including deep relaxation, self-compassion, acceptance, visualization, attention shifting and healthy movement, the FDA said in the release. A treatment program includes 56 virtual reality sessions that are two to 16 minutes long as part of a daily eight-week treatment program.
The FDA approval is based on a clinical trial that included 179 patients with chronic lower back pain assigned to one of two eight-week virtual reality programs: the EaseVRx 3-D program or a control 2-D program that did not feature CBT methods. At the end of treatment, 66 percent of EaseVRx participants reported a greater than 30 percent reduction in pain compared with 41 percent of those in the control group. A greater than 50 percent pain reduction was reported by 46 percent of the EaseVRx users compared with 26 percent of those in the control group, according to the FDA. One, two, and three months after treatment, all EaseVRx users still reported a 30 percent reduction in pain, which was higher than in the control group.
Nearly 21 percent of EaseVRx users reported discomfort with the headset, and about 10 percent reported motion sickness and nausea, but there were no serious side effects associated with the system, which is made by AppliedVR.