The US Food and Drug Administration (FDA) has cleared EaseVRx (AppliedVR), an immersive virtual reality (VR) system that uses the principles of cognitive behavioral therapy and other behavioral therapy techniques to reduce pain and pain interference in adults with chronic lower back pain.
"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," Christopher M. Loftus, MD, acting director, Office of Neurological and Physical Medicine Devices, FDA Center for Devices and Radiological Health, said in a news release.
"Pain reduction is a crucial component of living with chronic lower back pain. [This] 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 Loftus.
EaseVRx is a prescription device patients use at-home. It consists of a VR headset and a controller, along with a "breathing amplifier" for use in deep breathing exercises.
The VR program uses established principles of behavioral therapy intended to address the physiologic symptoms of pain and aid in pain relief through a skills-based treatment program.
"These principles include deep relaxation, attention-shifting, interoceptive awareness — the ability to identify, access, understand and respond appropriately to the patterns of internal signals — and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation," the FDA explains in the news release.
The EaseVRx treatment program comprises 56 VR sessions, each lasting between 2 and 16 minutes, and are intended to be used as part of a daily 8-week treatment program.
The EaseVRx system was tested in a randomized, double-blinded study of 179 adults with chronic lower back pain who were assigned to the EaseVRx immersive 3-D program or a control 2-D program that did not utilize skills-based CBT methods of treatment.
All participants were followed for 8 ½ months, including a 2-week baseline assessment period, an 8-week VR program, a posttreatment assessment, and follow-up at 1, 2, 3, and 6 months after completing the program.
At the end of treatment, a >30% reduction in pain was reported by 66% of EaseVRx participants compared with 41% of control participants. In addition, 46% of EaseVRx participants reported a >50% reduction in pain compared to 26% of control participants.
At 1-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain, which remained at 2 and 3 months follow-up. In contrast, the control group reported a reduction in pain below 30% at 1, 2, and 3 months.
On average, EaseVRx participants experienced a decrease in pain intensity of 1.31 points (on a 10-point scale) over the 8 weeks of treatment. They also reported a decrease in pain interference.
No serious adverse events were observed or reported during the study. About 21% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.
EaseVRx was granted breakthrough device designation and was reviewed through the de novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type.
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Cite this: FDA Clears Virtual Reality System to Ease Chronic Back Pain - Medscape - Nov 16, 2021.