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.

Laura M Garcia,Todd Maddox,Robert G Louis,Beth D Darnall,Vafi Salmasi,Ian G Mackey,Parthasarathy Krishnamurthy,Josh Sackman,Brandon J Birckhead

doi:10.2196/26292

Abstract

BackgroundChronic 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.ObjectiveWe aimed 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.MethodsA national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills 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 the between-group effect of EaseVRx versus Sham VR across time points, and the between–within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (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.ResultsThe study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre–post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR.ConclusionsEaseVRx 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 nonpharmacologic treatment for chronic low back pain.Trial RegistrationClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177International Registered Report Identifier (IRRID)RR2-10.2196/25291

Highlights

Chronic low back pain is the most prevalent chronic pain condition worldwide [1]. cLBP can be disabling, costly, and confer suffering to individuals and their families
While cognitive behavioral therapy (CBT) has not shown efficacy for reducing pain intensity, it has small to moderate effects for reducing depressive symptoms [7], pain bothersomeness [6,7], and pain catastrophizing [6,7] (Darnall et al, unpublished data) in mixed etiology chronic pain as well as cLBP
Because of the scope and impact of cLBP, there is an urgent need for effective, accessible, low-risk treatments that are acceptable to people who have back pain

Summary

Introduction

Chronic low back pain (cLBP) is the most prevalent chronic pain condition worldwide [1]. cLBP can be disabling, costly, and confer suffering to individuals and their families. An expert evidence review and consensus panel recommended pain education and cognitive behavioral therapy (CBT) as first-line treatments for cLBP [3] with both modalities supplying self-help information for back pain. Beyond the context of back pain, the Centers for Disease Control and Prevention [4] (CDC) and the Centers for Medicare & Medicaid Services (CMS) [5] have recommended nonpharmacologic therapies as first-line treatments for chronic pain, with the latter citing a need to improve patient access to effective treatment options. Despite demonstrated efficacy for these multisession behavioral pain treatments, access to care remains poor due to barriers such as few trained and available local therapists, health insurance limits, and burdens associated with travel and treatment time [8]. 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

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Results

Conclusion