The US Food and Drug Administration (FDA) has approved the first virtual reality (VR) system that uses cognitive behavioral therapy (CBT) in an immersive environment to help treat chronic lower back pain without opioids. EaseVRx is approved for use in adults 18 years and older diagnosed with chronic lower back pain, according to a statement released by the agency. EaseVRx was granted Breakthrough Device designation.
“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,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.
“Current treatment plans for chronic lower back pain often include, among other options, prescription and over-the-counter pain medications, exercise, steroid injections, surgery, and transcutaneous electrical nerve stimulation,” the FDA stated. “CBT may be used to reduce the burden of chronic pain and increase function through an emotional, cognitive, and behavioral approach to shift negative beliefs held by patients about the relationship between their pain and movement.”
The device, which requires a prescription, is meant for at-home use and consists of a VR headset and a controller. A breathing amplifier is attached to the headset and is used for deep breathing exercises.
The principles of CBT employed by EaseVRx include:
- Deep relaxation
- Interoceptive awareness and perspective-taking
- Immersive enjoyment
- Healthy movement
- Knowledge of pain
“The EaseVRx treatment program consists of 56 VR sessions that are 2 to 16 minutes long, intended to be used as part of a daily 8-week treatment program,” the FDA reported. “Each session incorporates elements of the principles to provide the user with skills to achieve relief and reduction in the interference of pain in daily activities.”
The approval of EaseVRx was based on the safety and efficacy data from a randomized double-blinded study involving 179 participants with chronic lower back pain. Participants were assigned to either 1 of 2 programs: the EaseVRx immersive 3-D program or a control 2-D program that did not utilize CBT. Participants were followed for a total of 8.5 months.
At the end of treatment, 66% of EaseVRx participants reported a greater than 30% reduction in pain compared with 41% of control participants. In addition, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared with 26% of control participants. For patients in the EaseVRx arm of the trial, reductions in pain continued at 1-month follow-up and remained at 2- to 3-month follow-up.
No serious adverse events were observed or reported during the study. Approximately 20.8% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.
EaseVRx is manufactured by AppliedVR.
US Food and Drug Administration. FDA authorizes marketing of virtual reality system for chronic pain reduction. October 27, 2021. Accessed November 17, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-virtual-reality-system-chronic-pain-reduction?utm_medium=email&utm_source=govdelivery