An immersive virtual reality (VR) system incorporating cognitive behavioral therapy (CBT) and other methods was approved to help treat chronic lower back pain, the Tuesday.
"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," said Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, in a statement.
"Pain reduction is a crucial component of living with chronic lower back pain," Loftus added. "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.
The FDA's decision was based on a of 179 people with chronic lower back pain who were randomly assigned to one of two 8-week VR programs: the EaseVRx immersive 3-D program or sham VR, a 2-D program without skills-based CBT methods. (The research team included Beth Darnall, PhD, of Stanford University School of Medicine in California, who is a member of the 鶹ý editorial board and chief science officer of AppliedVR, maker of EaseVRx.)
Participants were followed for 8.5 months total. At the end of the 8-week treatment program, 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.
At 1 month, all participants in the EaseVRx group continued to report a 30% reduction in pain. At 2 and 3 months, the 30% reduction in pain remained for all outcomes except pain intensity. In contrast, the sham VR group reported a reduction in pain below 30% at 1, 2, and 3 months for all outcomes.
Overall, the EaseVRx group experienced an average decrease in pain intensity of 1.31 points on a 10-point scale over 8 weeks of treatment. No serious adverse events were observed or reported during the study; 9.7% of EaseVRx users reported motion sickness and nausea.
EaseVRx was reviewed through the FDA's for low-to moderate-risk devices of a new type. Device maker Applied VR recently secured funding to to support other health conditions.