Dataset Information

Effect of a Behavioral Therapy-Based Virtual Reality Application on Quality of Life in Chronic Low Back Pain.

ABSTRACT:

Objectives

Low back pain is the leading cause of years lived with disability with a large impact on quality of life and resistance to a broad array of current treatments. This study aimed to investigate the effect of a novel self-administered behavioral therapy-based virtual reality (VR) application on the quality of life of patients with nonspecific chronic low back pain (CLBP).

Methods

A pilot randomized controlled trial was conducted in adults with nonspecific CLBP with moderate to severe pain, waiting for treatment in a teaching hospital-based pain clinic. The intervention group used a self-administered behavioral therapy-based VR application for at least 10 minutes daily for 4 weeks. The control group received standard care. The primary outcome was quality of life at 4 weeks measured by the short form-12 physical and mental scores. Secondary outcomes were daily worst and least pain, pain coping strategies, activities of daily living, positive health, anxiety, and depression. Discontinuation of therapy and adverse events were analyzed as well.

Results

Forty-one patients were included. One patient withdrew due to personal reasons. No significant treatment effect was found for the short form-12 physical score (mean difference: 2.6 points; 95% CI: -5.60 to 0.48) and mental score (-1.75; -6.04 to 2.53) at 4 weeks. There was a significant treatment effect for daily "worst pain score" ( F [1, 91.425] = 33.3, P < 0.001) and "least pain score" ( F [1, 30.069] = 11.5, P = 0.002). Three patients reported mild and temporary dizziness.

Discussion

Four weeks of self-administered VR for CLBP does not improve quality of life, however, it may positively affect daily pain experience.

SUBMITTER: Groenveld TD

PROVIDER: S-EPMC10205123 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Effect of a Behavioral Therapy-Based Virtual Reality Application on Quality of Life in Chronic Low Back Pain.

Groenveld Tjitske D TD Smits Merlijn L M MLM Knoop Jesper J Kallewaard Jan Willem JW Staal J Bart JB de Vries Marjan M van Goor Harry H

The Clinical journal of pain 20230601 6

<h4>Objectives</h4>Low back pain is the leading cause of years lived with disability with a large impact on quality of life and resistance to a broad array of current treatments. This study aimed to investigate the effect of a novel self-administered behavioral therapy-based virtual reality (VR) application on the quality of life of patients with nonspecific chronic low back pain (CLBP).<h4>Methods</h4>A pilot randomized controlled trial was conducted in adults with nonspecific CLBP with moderat ...[more]

PMID: 37002877

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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: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.

Project description: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/NCT04415177.International registered report identifier (irrid)RR2-10.2196/25291.

Project description:BackgroundChronic low back pain (cLBP) can interfere with daily activities, and individuals with elevated pain-related fear (also known as kinesiophobia or the fear of injury due to movement) can develop worse long-term disability. Graded exposure (GEXP) protocols use successive participation in avoided activities to help individuals overcome fearful movement appraisals and encourage activity. We sought to develop a series of GEXP virtual reality (VR) walking and reaching scenarios to increase the exposure and engagement of people with high kinesiophobia and cLBP.ObjectiveThis study aims to (1) determine GEXP content validity of the VR application and (2) determine the feasibility of individuals with cLBP performing locomotion-enabled physical activities.MethodsWe recruited 13 individuals with cLBP and high pain-related fear to experience six VR modules, which provide progressive movement exposure over three sessions in a 1 week period. At session 1, participants ranked each module by likelihood to avoid and assigned an expected pain and concern for harming their back rating to each module. Participants provided a rating of perceived exertion (RPE) after experiencing each module. To test feasibility, we administered the system usability scale (SUS) and treatment evaluation inventory (TEI) following the final session. In addition, we measured pain and pain-related fear at baseline and follow-up.ResultsThe 12 participants who completed the study period assigned higher avoidance (P=.002), expected pain (P=.002), and expected concern (P=.002) for session 3 modules compared with session 1 modules. RPE significantly increased from session 1 (mean 14.8, SD 2.3) to session 3 (mean 16.8, SD 2.2; P=.009). The VR application showed positive feasibility for individuals with cLBP through acceptable SUS (mean 76.7, SD 13.0) and TEI (mean 32.5, SD 4.9) scores. Neither pain (P=.20) nor pain-related fear (P=.58) changed significantly across sessions.ConclusionsThe GEXP VR modules provided progressive exposure to physical challenges, and participants found the VR application acceptable and usable as a potential treatment option. Furthermore, the lack of significant change for pain and pain-related fear reflects that participants were able to complete the modules safely.

Dataset Information

Effect of a Behavioral Therapy-Based Virtual Reality Application on Quality of Life in Chronic Low Back Pain.

Objectives

Methods

Results

Discussion

Publications

Effect of a Behavioral Therapy-Based Virtual Reality Application on Quality of Life in Chronic Low Back Pain.

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