An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19 (Preprint)

Abstract

BACKGROUND Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE To conduct a double-blind, parallel arm, single cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS A national online convenience sample of individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two 56-day VR programs: (1) EaseVRx (pain relief skills immersive VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were change in average pain intensity and pain-related interference with activity, stress, mood, and sleep (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS The study sample was 179 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx vs. Sham VR (p<0.0001). Both groups improved significantly for all five primary outcomes; EaseVRx was superior to Sham VR for all primary outcomes except pain-related sleep interference. For EaseVRx, large pre-post effect sizes ranged from 1.06-1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. A greater proportion of participants in the EaseVRx group achieved > 30% reduction in pain intensity (EaseVRx: 65.5%; Sham VR: 40.5%), and 46% of EaseVRx achieved >50% reduction in pain. Physical function and sleep disturbance significantly improved for both treatment groups with superior improvements found for EaseVRx (p=0.0019 and p=.0353, respectively). Pain catastrophizing, pain self-efficacy, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p<0.01) but not for Sham VR. CONCLUSIONS EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand non-pharmacologic treatment for chronic low back pain. CLINICALTRIAL ClinicalTrials.gov, NCT04415177 https://clinicaltrials.gov/ct2/show/NCT04415177 INTERNATIONAL REGISTERED REPORT RR2-25291

Digital self-care in the management of spine musculoskeletal disorders: A systematic review and meta-analysis

“…Regarding the design of the studies, all of them were RCTs, published between 2002 and 2022 with predominance of 2019 with 6 (24%) (2,(6)(7)(18)(19)(20) and of 2021 with 4 (16%) (8,15,(21)(22) . Of the 25 studies, 9 (36%)…”

“…were conducted in the United States of America (6,21,(23)(24)(25)(26)(27)(28)(29) , 5 (20%) in Australia (8,(18)(19)(20)30) , 3 (12%) in Germany (2,14,31) , 2 (8%) in Spain (17,32) , and 1 (4%) each in several countries such as India (33) , Netherlands (7) , Iran (15) , Jordan (16) , Italy (34) , Denmark and Norway (22) . The overall total was 5,142 participants, varying from 30 to 779 subjects in each study; 9 (36%) studies had sample sizes smaller than 100 participants (2,(14)(15)(16)(17)(18)(19)30,33) .…”

“…Regarding the digital therapeutic technologies, 9 (36%) used smartphone apps (2,6,(15)(16)19,22,26,31,33) , 9 (36%) resorted to websites and online programs (7)(8)17,20,(23)(24)(27)(28)32) , 2 (8%) employed telephones (25,30) , 1 (4%) chat discussion (14) , 1 (4%) email (29) , 1 (4%) virtual reality (21) , 1 (4%) Telemedicine (34) , and 1 (4%) video game (18) .…”

“…In general, the interventions involved physical exercises (2,(6)(7)(15)(16)(17)(18)(19)22,27,(31)(32)(33)(34) , education (2,(6)(7)(8)(21)(22)(23)(26)(27)29,32) and CBT (6,(20)(21)(23)(24)(25)(26)30) . The physical exercises were provided in the form of videos, audios or image-based instructions and could include performance feedback or not.…”

“…In addition to that, there was technology with sensors to evaluate the activities (33) , physical exercises with wearable sensors (6) , use of a pedometer (27) and tracker of activities (19) . The educational material referred to the spine-related pain, and one study was based on the Neuroscience of pain (21) . The psychosocial Regarding the spine region affected, 22 (88%) studies investigated pain in the low back area, with 90.9% prevalence of chronic pain; 1 (4.5%) study evaluated subacute non-specific low back pain (32) , 1 (4.5%) low back pain of any duration (8) and, in 3 (12%) studies, the pain was in the cervical region (15,31,34) .…”