An immersive virtual reality (VR) system incorporating cognitive behavioral therapy (CBT) and other methods was approved to help treat chronic lower back pain, the FDA announced [November 16].
“Pain reduction is a crucial component of living with chronic lower back pain,” [said FDA’s Christopher Loftus]. “Today’s authorization 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.”
The prescription EaseVRx device consists of a VR headset and controller, with a breathing amplifier attached to the headset that directs a patient’s breath during deep-breathing exercises. It is intended for home-based use.
The skill-based EaseVRx program incorporates CBT principles to engage patients in pain and symptom self-management, teaching deep relaxation, attention-shifting, awareness, healthy movement, visualization, knowledge of pain and rehabilitation, and other skills. It consists of 56 VR sessions 2 to 16 minutes long, which are part of a daily 8-week treatment plan.
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Participants were followed for 8.5 months total. At the end of the 8-week treatment program, 66% of the EaseVRx group and 41% of the sham VR group reported greater than 30% reduction in pain. Nearly half (46%) of EaseVRx participants reported a greater than 50% reduction in pain, compared with 26% of sham VR participants.
