VR Treatment for Chronic Pain Gets FDA Approval

The Food and Drug Administration has authorized a virtual reality system as a prescription treatment for chronic back pain, the agency announced today. The therapy, called EaseVRx, joins the shortlist of agency-approved digital therapies in recent years.

EaseVRx includes a virtual reality viewer and a device that amplifies the sound of the user's breathing to aid in breathing exercises. It uses principles of cognitive-behavioural therapy, which is to help people recognize and understand various patterns of thought and emotions. The program addresses pain via relaxation, distraction, and a better awareness of internal cues, the FDA said in its statement.

The FDA cleared EaseVRx based on data from an eight-week study of 179 people with lower back pain that lasted almost six months or more. Half used the EaseVRx program, and the other half participated in another two-dimensional virtual reality program that did not use cognitive behavioural therapy methods. About two-thirds of the participants who used EaseVRx said they had a pain reduction of more than 30 percent, while only 41 percent of the control group had a similar decline. In addition, pain reduction lasted up to three months after the study for people in the EaseVRx group, but not for the control group.

The virtual reality system could be an alternative option to opioid drugs for back pain, Christopher Loftus, acting director of the FDA's Office of Neurological and Physical Medicine Devices, said in a statement. Research shows that psychological approaches can be effective treatments for chronic pain for some people, and advocates emphasize that targeting those components at pain does not make the pain any less accurate. However, cognitive-behavioural therapy for pain is sometimes controversial, and efforts to integrate it into standard care have been met with concerns that it will be used as an excuse for people to abandon necessary medications.

EaseVRx was developed by the AppliedVR company, which is also testing its platform to treat fibromyalgia pain, burn pain, or labor pain.

Its approval for back pain comes about a month after the FDA approved another virtual reality treatment used to treat visual disorders in children. The agency also approved a prescription video game called EndeavorRx to treat ADHD in children ages eight to 12.