Sociodemographic Predictors of Clinical Effectiveness, Therapeutic Program Engagement, and Device Usability for an In-Home Virtual Reality Program for Chronic Low Back Pain: Secondary Analysis of a Randomized Controlled Trial.

Abstract

Health care inequities are well-established in chronic pain care. Immersive digital therapeutics may transcend such barriers by offering in-home access with no Wi-Fi connectivity required, and easy to use, gaze-based navigation, and therapeutic delivery. The objective of this report is to determine whether clinical effectiveness, therapeutic program engagement, and virtual reality (VR) device usability of an Food and Drug Administration (FDA)-authorized, proprietary skills-based VR program for chronic pain (i.e., RelieVRx^®) are affected by key sociodemographic factors (age, gender, race/ethnicity, and socioeconomic status [SES]) often associated with reduced patient engagement and clinical effectiveness. We report a secondary analysis of a large (n = 1,093) randomized controlled trial that compared skills-based VR with active sham VR. The sample was demographically diverse with self-reported nonmalignant chronic low back pain ≥3 months duration with average pain intensity and pain interference ≥4/10. Data were collected from January 31, 2022, to October 31, 2022. The clinical effectiveness, therapeutic program engagement, and VR device usability of skills-based VR were generally unaffected by age (<65 vs. 65+ years), gender (male vs. female), race/ethnicity (White vs. Black vs. other), and SES (education and income), with a few exceptions (age difference for therapeutic program engagement; race/ethnicity difference for device usability). National calls for improved access to nonpharmacological pain care are addressed with this skills-based VR program, which is self-administered in-home, requires no Wi-Fi connectivity, uses gaze-based navigation, and requires on average 6 min/day. TRIAL REGISTRATION: ClinicalTrials.gov NCT05263037.