Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial

Abstract

Background We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). Objective This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. Methods E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Results Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Conclusions Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. Trial Registration ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID) RR2-10.2196/25291

Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial

“…Nonpharmacological analgesic approaches include distraction, meditation, music, and relaxation—although there is currently sparse evidence supporting benefit. Various randomized trials of virtual reality presentations in patients with chronic lumbar pain or fibromyalgia report high user satisfaction, reduced pain, and meaningful reductions in pain-related interference with activity, mood, sleep, and stress, 19–21 as well as durability of the treatment effect for several months. 10 However, evidence is less consistent for acute or postoperative pain treatment with virtual reality–based interventions.…”

Digital therapeutics in the clinic

“…Patients can use this intervention to guide their motions to correctly perform the exercises and improve urinary incontinence symptoms. RelieVRx is approved for reducing pain intensity of patients suffering from chronic lower back pain 67,68 . In clinical trials, under an 8‐week period of intervention, patients in the RelieVRx treatment group reported lower indices for pain intensity compared to the sham group.…”

Effects of Fetal Images Produced in Virtual Reality on Maternal-Fetal Attachment: Randomized Controlled Trial

“…Virtual reality (VR) is the newest trend in computer-based technology that simulates objects or situations regardless of location or time [19,20]. It has been applied in numerous fields of health care, such as providing treatment [21][22][23], facilitating pain management [24][25][26], simulating surgery [27,28], providing guidance for rehabilitation [29], and enhancing medical education [30,31]. Because pregnant women are not able to see their babies before giving birth, they perceive the existence of the fetus by indirect factors, such as fetal movement or grayscale videos viewed during ultrasonography examinations.…”