(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% of EaseVRx participants reported a greater than 30% reduction in pain compared with 41% of those in the control group. A greater than 50% pain reduction was reported by 46% of the EaseVRx users compared with 26% 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% of EaseVRx users reported discomfort with the headset, and about 10% reported motion sickness and nausea, but there were no serious side effects associated with the system, which is made by AppliedVR.
