Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study.

BACKGROUND: Background: Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapeutic with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations.

OBJECTIVE: Objectives: The primary goal of this study was to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary goal was to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary goal was to conduct a randomized controlled trial (RCT) and compare the VR treatment to an audio-only treatment; this comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect.

METHODS: Methods: We conducted an RCT involving an online convenience sample of adults (N=97) 18-65 years of age with self-reported chronic non-malignant chronic low back pain or fibromyalgia with an average pain intensity > 4 over the past month, and chronic pain duration > 6 months. Enrolled participants were randomly assigned to one of two unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) Audio: an audio-only version of the 21-day VR program. The analytic dataset included participants who completed at least one of eight surveys administered during the intervention period: VR (n=39) and Audio (n=35).

RESULTS: Results: The VR group launched a total of 1067 sessions vs. 1048 sessions for Audio group. The majority of VR participants (19 of 25; 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (24 of 29; 83%) and Audio (26 of 33; 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001) with results strengthening after two weeks. Importantly, significant time x group effects were found in favor of the VR group for average pain intensity (P=.036), and pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain-catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups.

CONCLUSIONS: Conclusions: High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability for at-home skills-based VR for chronic pain. Significant reduction in pain outcomes over the course of the 21-day treatment both within VR group and compared to an audio-only version suggests VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain.

CLINICALTRIAL: Our CT.gov is in progress and will be received this week (clearly retrospective). The efficacy aim of our pilot study was exploratory and we applied appropriate statistical corrections for multiple comparisons.