New research on therapeutic virtual reality reports that an in-home, interactive program for chronic pain appeared superior to a non-interactive sham app experience for reducing multiple measures of pain among participants with self-reported chronic low back pain.

Published earlier this week in JMIR, the study was funded by therapeutic VR company AppliedVR and conducted by its employees alongside Stanford University School of Medicine and Hoag Memorial Hospital researchers.

Alongside the pain measures, the double-blind study suggested that participants were satisfied with the eight-week EaseVRx program and largely adhered to the treatment.

Notably, participants received financial compensation for completing study questionnaires, and were eligible to receive a VR headset as a gift as a result of their participation.

In addition, the investigation was conducted remotely during the COVID-19 pandemic, when interest in an at-home program could be greater among participants, the researchers wrote.

TOP-LINE DATA

The 179 adults included as participants were 90.5% Caucasian, 76.5% female, a mean 51.5 years of age and largely reporting some amount of college education. At baseline, two-thirds reported that their back pain duration had been present for five or more years, and on average self-rated the intensity of their pain as a five out of 10.

Based on device use data collected by the headsets and self-report surveys, engagement was statistically similar between the study and sham groups (5.4 sessions per week versus 6 per week).

Nausea and motion sickness was reported by 9.7% and 6.7% of the treatment and sham group participants who completed a post-treatment survey, which was again a nonsignificant difference. No participants reached out to study staff regarding adverse events of any type during the treatment phase itself.

While both groups had a significant decrease in average pain intensity over time (P < .001), the researchers observed significantly lower average pain intensity among the treatment group compared to the sham group overall (P = .001) and over time (P < .001). Overall average reduction in pain intensity among those who received the therapeutic VR program was 42%, with 87% of those who received EaseVRx reporting any reduction in pain.

This general trend persisted across most measures of pain-related interference (activity, mood and stress), where both groups would demonstrate a significant treatment effect that was greater among those receiving EaseVRx. Pain interference with sleep was the only exception, where both groups were significantly effective, but there was no difference between groups over time (P = .755).

Participants reported greater satisfaction with the EaseVRx program compared to the sham, and said they were more likely to recommended VR to someone else and keep using the software if they could keep their device (P < .001 for all). Neither group reduced their use of prescription opioid, although over-the-counter analgesic use dropped significantly for EaseVRx users (P < .01).

HOW IT WAS DONE

The researchers recruited a nationwide convenience sample of individuals with self-reported chronic lower back pain through chronic pain organizations, Facebook online advertisements and professional contacts at medical clinics. These participants completed a baseline survey, three pain surveys during a two-week assessment period, twice weekly during the treatment phase, and at treatment completion.

Objective use data was collected directly from the VR headsets. Meanwhile, the surveys included standardized scales for measuring average pain intensity, pain interference, impression of change, physical function, sleep disturbances, pain-related emotion, treatment satisfaction, medication use and other related metrics.

Participants were incentivized to complete these surveys with gift cards (up to a possible $126), and had the option of receiving a VR headset after study completion (77 of which were claimed).

All participants received a Pico G2 4K VR headset through the mail at no cost. For some, these were loaded with the EaseVRx software, an interactive program that includes pain education, pain distraction games, mindful escapes and breathing-based biofeedback training. Others received the sham VR app, which displayed 2-D scenes of nature that were accompanied by "neutral" music and were not interactive.

THE LARGER TREND

VR is being investigated for clinical applications that run the gamut of behavioral health and neurorehabilitation, but the lion's share of encouraging literature to date has been in regard to pain reduction.

While these studies have frequently been conducted within the hospital setting, VR stakeholders like Hoag Memorial Hospital's Dr. Robert Louis (also a coauthor on the AppliedVR study) told MobiHealthNews last year that the pandemic has led his organization reevaluate their in-hospital projects. Similarly, Dr. Brennan Spiegel, director of health services research at Cedars-Sinai and a therapeutic VR advocate, said that his organization saw interruptions to VR research with the sole exception of a program shipping headsets directly to patients at home.

AppliedVR has also been maintaining a forward momentum throughout the pandemic. The company backed another study over the summer that found self-administered, at-home VR outperformed an audio-only resource for chronic pain. In October, the company landed an FDA Breakthrough Device designation for EaseVRx, an update that the company noted could pan out into temporary Medicare coverage thanks to a rule recently finalized by CMS.

“After yet another successful clinical trial, we’ve reinforced AppliedVR’s unwavering commitment to being the most effective, cost-conscious and data-backed VR-based solution for chronic pain on the market,” Josh Sackman, cofounder and president of AppliedVR, said in a statement highlighting the study results.

“And now that CMS and forward-thinking commercial payers are seeing the outcomes that digital therapeutics like ours can deliver, we fully expect EaseVRx to soon be a provider-prescribed, payer-reimbursed treatment for multiple chronic-pain indications.”

AppliedVR isn't alone in the space, either. XRHealth, for instance, offers a range of VR-based applications and telehealth services focused on pain management, stress, motor function and other areas. It also announced a $7 million funding round last spring, and told MobiHealthNews shortly after that it was seeing increased demand during the pandemic.

IN CONCLUSION

"The findings broadly suggest that VR holds promise as effective, stand-alone, home-based digital behavioral medicine for chronic pain. Additional studies are needed, including larger sample sizes, diverse chronic pain conditions, longer duration of study to best characterize the efficacy of VR in chronic pain management, and the impact of VR on other factors such as pain medication use and medical care utilization. Future studies may further elucidate the VR mechanisms of action and VR’s role in expanding access to multimodal behavioral medicine for chronic pain," the researchers concluded.