The Food and Drug Administration authorized a virtual reality system as a prescription treatment for chronic back pain, the agency announced today. The therapy, called EaseVRx, joins the short list of digital therapeutics cleared by the agency over the past few years.
EaseVRx includes a VR headset and a device that amplifies the sound of the user’s breath to assist in breathing exercises. It uses principles from cognitive behavior therapy, which aims to help people recognize and understand various thought patterns and emotions. The program addresses pain through relaxation, distraction, and improved awareness of internal signals, the FDA said in its statement.
The FDA authorized EaseVRx based on data from an eight-week study in 179 people with low back pain that had lasted six months or longer. Half used the EaseVRx program and half participated in another, two-dimensional virtual reality program that did not use cognitive behavioral therapy methods. Around two-thirds of participants using EaseVRx said they had more than 30 percent reduction in pain, while only 41 percent of the control group had a similar reduction. The reduced pain lasted for up to three months after the study for people in the EaseVRx group but not for the control group.
The VR system could be an alternative option to opioid medications for back pain, Christopher Loftus, acting director of the Office of Neurological and Physical Medicine Devices at the FDA, said in a statement. Research shows that psychological approaches can be effective treatments for chronic pain for some people, and proponents stress that targeting those components to pain doesn’t mean the pain is any less real. Still, cognitive behavioral therapy for pain is sometimes controversial and efforts to integrate it into standard care have been met with worries that it’ll be used as an excuse to pull people off needed medications.
EaseVRx was developed by the company AppliedVR, which is also testing its platform as a treatment for fibromyalgia pain, burn pains, or pain during childbirth.
Its clearance for back pain comes around a month after the FDA approved another VR treatment, used to treat a visual disorder in children. The agency has also cleared a prescription video game called EndeavorRx to treat ADHD in kids between eight and 12 years old.