Dataset Information

Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial.

ABSTRACT: Whereas the fear-avoidance model of chronic low back pain (CLBP) posits a generic avoidance of movement that is perceived as threatening, we have repeatedly shown that individuals with high fear and CLBP specifically avoid flexion of the lumbar spine. Accordingly, we developed a virtual dodgeball intervention designed to elicit graded increases in lumbar spine flexion while reducing expectations of fear and harm by engaging participants in a competitive game that is entertaining and distracting. We recruited 52 participants (48% female) with CLBP and high fear of movement and randomized them to either a game group (n = 26) or a control group (n = 26). All participants completed a pregame baseline and a follow-up assessment (4-6 days later) of lumbar spine motion and expectations of pain and harm during standardized reaches to high (easier), middle, and low (hardest to reach) targets. For 3 consecutive days, participants in the game group completed 15 minutes of virtual dodgeball between baseline and follow-up. For the standardized reaching tests, there were no significant effects of group on changes in lumbar spine flexion, expected pain, or expected harm. However, virtual dodgeball was effective at increasing lumbar flexion within and across gameplay sessions. Participants reported strong positive endorsement of the game, no increases in medication use, pain, or disability, and no adverse events. Although these findings indicate that very brief exposure to this game did not translate to significant changes outside the game environment, this was not surprising because graded exposure therapy for fear of movement among individuals with low back pain typically last 8 to 12 sessions. Because of the demonstration of safety, feasibility, and ability to encourage lumbar flexion within gameplay, these findings provide support for a clinical trial wherein the treatment dose is more consistent with traditional graded exposure approaches to CLBP.This study of a virtual reality dodgeball intervention provides evidence of feasibility, safety, and utility to encourage lumbar spine flexion among individuals with CLBP and high fear of movement.

SUBMITTER: Thomas JS

PROVIDER: S-EPMC5125833 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial.

Thomas James S JS France Christopher R CR Applegate Megan E ME Leitkam Samuel T ST Walkowski Stevan S

The journal of pain 20160909 12

Whereas the fear-avoidance model of chronic low back pain (CLBP) posits a generic avoidance of movement that is perceived as threatening, we have repeatedly shown that individuals with high fear and CLBP specifically avoid flexion of the lumbar spine. Accordingly, we developed a virtual dodgeball intervention designed to elicit graded increases in lumbar spine flexion while reducing expectations of fear and harm by engaging participants in a competitive game that is entertaining and distracting. ...[more]

PMID: 27616607

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Project description:BackgroundChronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed.ObjectiveIn this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP).MethodsWe will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data.ResultsThe study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020.ConclusionsEffectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches.Trial registrationClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.International registered report identifier (irrid)RR1-10.2196/25291.

Project description:Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program.The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability.A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points.Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ?4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant.Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements.ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).

Dataset Information

Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial.

Publications

Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial.

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