Virtual reality program for back pain superior to sham device 3 months after treatment

Three months after a cohort of patients used a home-based therapeutic virtual reality program called EaseVRx, data indicated it was superior to a sham device in several clinical measures related to the user’s chronic lower back pain.

“Back pain is the leading type of pain globally,” Beth Darnall, PhD, the director of the Stanford Pain Relief Innovations Lab, told Healio. “Currently available treatments for back pain may be effective but often are inaccessible. For other people, currently available treatments, including pharmaceuticals, may be insufficient or unwanted. Home-based treatment options are needed to scale convenient access to whole person pain care.”

According to a press release, EaseVRx (AppliedVR) includes a VR headset with skill-based programs that cover topics such as deep relaxation, attention-shifting, interoceptive awareness (which includes the ability to access, understand and respond appropriately to the patterns of signs that indicate pain), as well as perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation.

The “sham virtual reality involved 2D nature scenes and neutral music delivered in a virtual reality headset,” Darnall explained. “Instead of the 3D immersive experience of therapeutic virtual reality, the sham virtual reality was like watching a TV screen inside a headset that restricted vision and limited sound.”

EaseVRx also includes a controller and a device that assist in the user’s deep breathing exercises. A full EaseVRx treatment consists of 56 sessions (one daily for 8 weeks) that range from 2 to 16 minutes in length. The FDA authorized marketing of the device in November after a randomized controlled study of 188 patients with chronic lower back pain and other similar characteristics showed that significantly more EaseVRx users reported a reduction in pain greater than 30% at the end of treatment compared with those who used the sham device.

“Importantly, therapeutic virtual reality involves experiences and exercises that encourage interoceptive awareness and self-regulation; the sham virtual reality had no such therapeutic content,” Darnall said.

In the new paper, Darnall and colleagues analyzed surveys that all trial participants completed 3 months after finishing their respective treatment and reported that:

• Mean pain intensity improvement was 30.3% for those in the EaseVRx group and 15.8% in the sham VR cohort.
• Mean improvement in pain interference with activity was 36.6% and 15.7%, respectively.
• Mean improvement in pain interference with mood was 28.8% and 14%, respectively.
• Mean improvement for pain interference with sleep was 19.8% and 19.1%, respectively.
• Mean improvement in pain-interference with stress was 37.4% and 17%, respectively.
• Mean physical function improvement was 8.9% and 5.2%, respectively.
• Mean improvement for sleep disturbance was 2.2% and 4.3%, respectively.

All the variables, except for mean improvement for sleep disturbance, had an effect that was considered either medium or large, according to the researchers. Future studies will examine EaseVRx’s effectiveness 6 months after finishing treatment, and “should prioritize diversity in race, ethnicity and education,” the researchers wrote.

Darnella added in the interview that “self-administered virtual reality makes home-based pain care possible. The headset can arrive at a person’s home, enabling them to begin immediate self-treatment with a standardized, evidence-based program. Our results suggest that the virtual reality program reduces pain intensity and pain interference across a range of domains, with results lasting 3 months post-treatment.”

She added that EaseVRx is meant to be prescribed by health care providers and reimbursed by a payer, and added that the efforts are underway in those areas in an attempt to make EaseVRx “fully market active in 2023.”

References

FDA authorizes marketing of virtual reality system for chronic pain reduction. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-virtual-reality-system-chronic-pain-reduction?utm_medium=email&utm_source=govdelivery. Published Nov. 16, 2021. Accessed Jan. 5, 2022.

Garcia LM, et al. J Pain. 2021;doi:10.1016/j.jpain.2021.12.002.