EaseVRx (AppliedVR) is approved by the US Food and Drug Administration (FDA). This immersive virtual reality (VR) system makes use of cognitive behavioral therapy principles and other techniques for behavioral therapy to decrease pain and interfere for people suffering from chronic lower back pain..
“Millions of Americans suffer from chronic lower back pain that affects the quality of their lives in many ways,” Christopher M. Loftus MD, acting director, Office of Neurological and Physical Medicine Devices FDA Center for Devices and Radiological Health announced in a press release.
“Pain relief is an essential aspect of living with chronic lower back pain. This authorization offers an option for pain relief that does not contain opioid pain medication when combined with other treatment methods for chronic lower back pain,” said Loftus.
EaseVRx is a prescription device patients use at-home. It includes a VR headset, a controller, and a “breathing amplifier” to aid in breathing exercises.
The VR program uses established principles of behavioral therapy designed to address the physiological symptoms of pain. It also assists in pain relief by utilizing an individualized treatment program based on skills.
The FDA stated in a news release that these guidelines include deep relaxation and attention-shifting. They also include interoceptive consciousness, which is the ability to detect, comprehend and respond to internal signals.
The EaseVRx treatment program comprises 56 VR sessions that last between 2 and 16 minutes, and are intended to be utilized as part of a daily 8-week program of treatment.
The EaseVRx system was tested in a double-blinded, randomized study of 179 adults with chronic lower back pain. They were randomized to either the EaseVRx immersive 3-D program or to a 2-D program that did not use CBT strategies based on the use of skills.
All participants were monitored for 8 1/2 months. This included a 2 week baseline assessment, an 8-week VR course, and a post-treatment assessment. Follow-up was available at 1 2, 3, and 6 months.
66% of EaseVRx participants reported a reduction of pain by more than 30% compared to 41% of control participants. In addition 46% of EaseVRx participants reported a >50% reduction in pain in comparison to 26% of control participants.
After a one-month follow-up all participants in the EaseVRx group continued to report a reduction of 30% in pain, which was maintained at 2 and 3 months after follow-up. The control group reported a reduction in pain that was less than 30% at 1, 2, and 3 months.
EaseVRx participants saw an average decrease in pain intensity by 1.31 points (on the 10-point scale) over the course of 8 weeks. They also noted a decrease in pain interference.
No serious adverse events were reported or observed during the study. About 21% of participants experienced discomfort with the headset, while 9.7 percent reported experiencing motion sickness or nausea.
EaseVRx was granted the designation of breakthrough device and was evaluated through the de-novo premarket review process, an approved regulatory process for low-to moderate-risk devices of a new kind.
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