Dataset Information

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 (d_s=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (d_s=0.34; P=.02 and d_s=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.

SUBMITTER: Garcia L

PROVIDER: S-EPMC9177046 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Garcia Laura L Birckhead Brandon B Krishnamurthy Parthasarathy P Mackey Ian I Sackman Josh J Salmasi Vafi V Louis Robert R Castro Carina C Maddox Roselani R Maddox Todd T Darnall Beth D BD

Journal of medical Internet research 20220525 5

<h4>Background</h4>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 ...[more]

PMID: 35612905

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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 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:BackgroundChronic low back pain (LBP) is a leading cause of disability worldwide. Biopsychosocial rehabilitation programs have been advocated for its management, especially since the widespread acceptance of the biopsychosocial model of chronic pain. Despite extensive evidence of its short-term benefits, few studies have reported on its long-term effect and more specifically on indirect outcomes such as return to work and quality of life (QoL). The present study evaluated the long-term effect of a multidisciplinary biopsychosocial rehabilitation (MBR) program for patients with chronic LBP, for which short- and intermediate-term efficacy had been established, with an emphasis on recovering work capability.MethodsThis prospective cohort study enrolled 201 patients on a four-week MBR program incorporating physical and occupational therapies and psychological counselling. Assessments occurred at program admission and discharge and at 6 and 18 months. Work capability, Oswestry Disability Index, Tampa Scale for Kinesiophobia, Core Outcome Measures Index (COMI), and Hospital Anxiety and Depression Scale were assessed. Multiple mixed models were used to detect changes in each outcome. Logistic regressions were calculated to identify predictors of recovery of work capability.ResultsOf the 201 patients who fulfilled the eligibility criteria, 160 (79.8%) attended the discharge assessment, 127 (63.2%) attended the 6-month follow-up, and 107 (53.3%) continued to the 18-month follow-up. Initially, 128 patients (71.5%) had been on sick leave. At 6 and 18 months, 72 (56.7%) and 84 (78.5%) participants had recovered their work capability, respectively. There were significant improvements in pain, disability, kinesiophobia, and anxiety and depression scores over time. Patients who recovered work capability showed significantly greater improvements in their total COMI score, general QoL, and disability, which were the best three predictors of recovering work capability.ConclusionsThis study extends previous results confirming the program's contribution to recovering work capability among chronic LBP patients.

Project description:BackgroundDuchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD) are neuromuscular diseases. DMD is the most prevalent in children. It affects dystrophin production, reducing the patient's mobility and quality of life. New technologies have become a part of physical therapy in DMD and BMD. During the COVID-19 pandemic, conducting telerehabilitation through virtual reality-based games could help these children maintain their physical abilities.ObjectiveThis study examined if the use of a virtual platform in a multimodal intervention program changes the results of the 6-minute walk test (6MWT) in children with DMD and BMD. The main objective was to test whether children with DMD and BMD obtain different results on the 6MWT after completing 10 telerehabilitation treatment sessions. The secondary objective was to measure whether other specific motor scales also produce different results after the 10 defined sessions.MethodsThis was a descriptive, open, and quasi-experimental study with a prospective A-B (control-intervention) design. A sample of 12 participants who fulfilled the inclusion criteria followed the program for 5 weeks with 10 telerehabilitation sessions. During the sessions, the participants used virtual reality glasses to train for the treatment goals. All participants were assessed in person before and after the intervention. Analysis was performed using R software according to the different functional assessments performed for each test.ResultsThe participants showed a 19.55-meter increase in the 6MWT. Motor function also remained stable according to other scales used to assess it. The North Start Ambulatory Assessment scores were stable in both treatment conditions (P=.20). Furthermore, the timed up and go test results were 0.1 seconds faster in the telerehabilitation condition, and the Motor Function Measure in all of the 3 dimensions showed no significant differences (P=.08). Finally, the Effort Perception Infant scale showed that during the training, fatigue increased in the middle and decreased by the end of the sessions, but the perception throughout the sessions was lower even as the exercise intensity increased.ConclusionsThere were no differences between conventional and telerehabilitation treatments, so the telerehabilitation tool could be used without harming children with DMD and BMD, facilitating their access to therapies and stimulating learning to maintain their functional capacity. Therefore, telerehabilitation in general may be helpful in maintaining motor function in children with DMD and BMD. The learning effect helped reduce the feeling of fatigue in the children during the program.

Project description:BackgroundVirtual reality (VR) is helpful for the management of stress and anxiety. However, current interventions have limitations related to location (ie, therapist's office or hospitals) and content (ie, virtual experiences only for relaxation).ObjectiveThis randomized pilot trial aims to investigate the efficacy and acceptability of a brief remote VR-based training for supporting stress and anxiety management in a sample of Italian health care workers.MethodsA total of 29 doctors and nurses (n=21; 72% female; mean age 35.6, SD 10.3 years) were recruited and randomized to a VR intervention group or a control group in a passive control condition. Participants assigned to the VR intervention group received remote VR-based training consisting of 3 sessions at home delivered in 1 week using the VR psychoeducational experience "MIND-VR" and the 360° relaxing video "The Secret Garden." The primary outcome measures were stress, anxiety, depression, and the knowledge of stress and anxiety assessed at baseline and posttreatment. We also evaluated the immediate effect of the remote VR-based training sessions on the perceived state of anxiety and negative and positive emotions. The secondary outcome measure was the usability at home of the VR system and content.ResultsThe VR intervention significantly reduced stress levels as assessed by the Perceived Stress Scale (6.46, 95% CI 2.77 to 10.5; P=.046) and increased the knowledge of stress and anxiety, as evaluated by the ad hoc questionnaire adopted (-2.09, 95% CI -3.86 to -0.529; P=.046). However, the home-based VR training did not yield similar reductions in stress, anxiety, and depression levels as assessed by the Depression, Anxiety, and Stress Scale-21 items or in trait anxiety as evaluated through the State-Trait Anxiety Inventory Form Y-1. After the home training sessions with VR, there was a significant decrease in anxiety, anger, and sadness and an increase in happiness levels. Analyses of the questionnaires on usability indicated that the health care workers found using the VR system at home easy and without adverse effects related to cybersickness. Of 33 participants, 29 (88%) adhered to the protocol.ConclusionsThe results of this randomized pilot study suggest that a week-long home VR intervention, created with content created specifically for this purpose and available free of charge, can help individuals manage stress and anxiety, encouraging further research investigating the potential of remote VR interventions to support mental health.Trial registrationClinicalTrials.gov NCT04611399; https://tinyurl.com/scxunprd.

Project description:BACKGROUND:Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations. OBJECTIVE:The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT) and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect. METHODS:We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35). RESULTS:The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants (n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio (n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups. CONCLUSIONS:High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain.

Dataset Information

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.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

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.

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