According to the press release of Food and Drug Administration (FDA) on November 16, 2021, the prescription-use immersive virtual reality (VR) system has been granted marketing authorization for pain relief in patients aged 18 years and above with chronic low back pain. The VR system uses cognitive behavioural therapy (CBT) and other behavioural methods for the same.

Chronic pain is associated with disruption of day-to-day activities, anxiety and depression, poor perceived health or poor quality of life and opioid dependence. This authorized, easy to use at home, VR system is based on the principles of CBT and other behavioural therapy practices for pain reduction which works on the principles of behavioural therapy used are deep relaxation, interoceptive awareness, understanding and responding suitably to the patterns of internal signals and perspective-taking, knowledge of pain and rehabilitation, etc.

The therapy program includes 56 VR sessions of 2 to 16 minutes intended to be used as part of the everyday 8-week treatment program for effective pain relief. The safety and efficacy of this device have been assessed in 179 chronic low back pain patients who were allotted to one of two 8-week VR programs: the VR 3-D program or a control 2-D program with a follow-up of 8.5 months. Pain reductions reported by the end of treatment is depicted in Table 1:

A 10-point scale was used for efficacy assessment where the patients were asked to rate pain intensity, and pain interference on activity, mood, sleep and stress after 8 weeks. The patients reported a reduction in pain intensity of 1.31 points on average. Although no severe adverse events were reported, 20.8% of patients had uneasiness with headset and 9.7% had motion sickness.

This prescription device has been permitted as Breakthrough Device designation. The FDA assessed this VR device via a regulatory pathway, known as De Novo premarket review pathway used for new low-to moderate-risk devices.