FDA Grants Approval for Treatment Of Chronic Back Pain With VR System

Dec, 2021 - By SMI

The U.S. FDA approved a VR system, EaseVRx combined with a system designed for reducing chronic lower back pain using cognitive behavioural therapy. 

A year ago, the U.S. FDA granted approval to EaseVRx system developed by AppliedVR making it one of the first VR-based digital therapeutic systems to get the designation. Now a year later, the FDA approved the marketing of EaseVRx, a system using cognitive behavioural therapy and other behavioural methods that help to reduce pain in patients above 18 years of age with chronic back pain.

The VR system, EaseVRx includes a VR headset with controller, and a breathing amplifier that is designed to direct breathing sounds back into the microphone of the headset, which helps breathing-based biofeedback exercises. This program uses pre-existing cognitive behavioural therapy (CBT) principles. The device was tested in clinical trial having a group of 179 subjects suffering from chronic pain, which showed positive results. Half of the participants were assigned with eight-week EaseVRx program, and the other half received a VR headset. However, only the headset in the second group has only experienced sessions featuring 2D footage of nature without CBT.

When the eight-week treatment period ended, it was observed that 2/3^rd of the EaseVRx group reported 30% pain reduction and 46% of the group reported 50% pain reduction. While in the control group, 41% of participants reported 30+% reduction in pain and 26% of the group reported 50+ % drop in pain. A three months follow up period was also included in the trial to assess the long-term effects of the therapy. The VR group strongly held the ratings for pain reduction for three months, while the control group small amounts of benefits after 12 weeks. The marketing of EaseVRx shall be started soon, yet the cost of the device is no revealed.