The U.S. Food and Drug Administration recently approved the marketing of EaseVRx, a program created by VR therapeutic company AppliedVR to help with chronic back pain.
EaseVRx is an immersive program that uses a combination of techniques such as cognitive behavioral therapy alongside other behavioral therapy methods to reduce pain.
Using these methods to help people comprehend emotions and thinking, the program relieves pain by working on principles such as relaxation, healthy movement and visualization. According to a statement released by the FDA, the program also incorporates interoceptive awareness which is the capability to recognize internal signals and respond to them.
Released as a prescription treatment for chronic back pain, EaseVRx is made up of 56 VR sessions. The program is intended for daily use for a total of eight weeks with each session lasting two to 16 minutes. In addition to a headset, recipients will receive a “Breathing Amplifier.” This device is put on the headset to move the user’s breath to the microphone to intensify the sound during breathing exercises and further immerse them.
The FDA came to the decision after an eight-week study was conducted. The study consisted of 179 people that reported having lower back pain for six months or more. The research participants were split into two groups.
One group was given EaseVRx while the other was given a 2-D VR program made without cognitive behavior therapy. Both groups were then asked a series of questions on a 10-point rating scale,
About 66% of those using EaseVRx reported a 30% or more decrease in pain while only 41% of the participants in the other group reported the same results. When the participants came in for a one-month check-up, those that used EaseVRx maintained the 30% or more pain reduction.
The new program provides an alternative method to opioid medication.
“[EaseVRx] offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices at the FDA, in the statement for the authorization.
The program’s use of cognitive-behavioral therapy however can be a source of controversy. The method of treatment has been previously accused of being a way of getting people off of necessary medication.
The FDA’s decision to allow the product to go through to marketing comes after other recent VR-related approvals. In addition to EaseVRx, the FDA gave the okay for the use of VR when it comes to children with lazy eyes.
