At-Home Virtual Reality Program for Chronic Low Back Pain: A Randomized Controlled Trial in a Clinically Severe and Demographically Diverse Sample

Chronic low back pain (CLBP) is the most prevalent chronic pain condition worldwide.1 As healthcare professionals reduce their reliance on opioids to treat cLBP, clinicians are faced with few low-risk options for patients who remain in severe pain. Chronic pain experts recommend pain education and cognitive behavior therapy (CBT) as first-line treatments for cLBP that are effective. 2, 3, 4 The CDC and CMS 5, 6 concur, but also cite the need to improve patient access to effective treatments. CBT and other behavior interventions often require multiple sessions with a trained therapist. Thus access to care remains poor due to barriers such as few trained and available local therapists, health insurance limits, and burdens associated with travel and treatment time.7 There is an urgent need for effective, accessible, in-home, low-risk treatments that are acceptable to people with cLBP. The growing field of digital therapeutics, in particular immersive therapeutics like virtual reality (VR), offers the promise of home-based care, broad availability of treatment and the potential to address the needs of underserved populations with cLBP. 

We recently completed a double-blind, randomized placebo-controlled comparison of an FDA authorized 8-week self-administered behavioral skills-based VR program (RelieVRxR) with shamVR in 188 adults with cLBP.8 Both treatments were delivered via the same commercial VR headsets and involved 56 brief (6 minutes per day) daily treatment sessions. Clinically meaningful reductions (≥ 30% or 2 points) in pain intensity and pain interference were observed at end of treatment (ref) for the RelieVRx program and were significantly larger than for Sham. 

Although these results are promising, the sample size was modest (< 200), and homogeneous (predominantly female, white, college educated, without depressive symptoms). To address these shortcomings we conducted a double-blind, randomized placebo-controlled comparison of the RelieVRx program with Sham in N=1093 adults with cLBP. Recruitment was targeted to obtain more male and demographically diverse participants, including more non-Caucasians and a broad array of education and economic levels. We also enrolled participants across a range of depressive symptom severity with no limitation or threshold. Finally, we obtained participant consent to access medical records and claims.

Purpose/Objectives:

A national online sample of nearly 1100 individuals with self-reported non-malignant low back pain > 3 months duration and with average Brief Pain Inventory pain intensity and pain interference > 4/10 were enrolled and randomized 1:1 to one of two daily (56-day) VR programs: (1) RelieVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). 

The RelieVRx program is an immersive multi-modal, skills-based, pain self-management VR program that incorporates evidence-based principles of CBT, mindfulness, and pain neuroscience education. The RelieVRx program combines biopsychosocial education, diaphragmatic breathing training, relaxation response exercises that activate the parasympathetic nervous system, and executive functioning games to provide a mind-body approach toward pain relief. The standardized 56-day program delivers a multifaceted combination of pain relief skills training through a prescribed sequence of daily immersive experiences. Each VR experience is 2-16 minutes in length (average of 6 minutes). The VR treatment modules were designed to minimize triggers of emotional distress or cybersickness. In compliance with Virtual Reality Clinical Outcomes Research Experts (VR-CORE) clinical trial guidelines, we selected an active control that utilizes non-immersive, two-dimensional (2D) content within a VR headset as the most rigorous VR placebo.9 The Sham VR headset displayed 2D nature footage (e.g., wildlife in the savannah) with neutral music selected to be neither overly relaxing, aversive nor distracting. The experience of Sham VR is similar to viewing nature scenes on a large screen television and is not interactive. Experiences varied in length from 1:42 to 6:30 minutes.

Self-reported data were collected at pre-treatment, twice a week during the treatment, and immediately at the end of treatment.

Method:

The study sample was 1093 demographically diverse adults (female: 77%; non-Caucasian: 32%; high school or less education: 19%; mean age: 50.8). The sample was also clinically severe with baseline pain intensity = 6.6, baseline pain interference = 6.2, baseline disability in the severe/disabled range, no exclusions for depression level, and moderate to severe sleep disturbance. 

At the end of treatment (EoT) relative to pre-treatment, the RelieVRx group demonstrated an average pain intensity drop of 2.0 points (effect size = 1.02), and an average pain interference drop of 2.2 points (effect size = 1.04); both significantly larger than for the Sham group (p = .0004 for intensity, p = .00001 for interference).

Next we examined the percentage of participants who achieved a clinically meaningful pain reduction (≥ 30% or 2 points). For both pain intensity and pain interference, the RelieVRx group had a significantly higher odds of being a pain intensity and pain interference responder (largest p = .005). For RelieVRx group, 46% of participants achieved at least a 2 point reduction in pain intensity, 51% of participants achieved at least a 2 point reduction in pain interference, and 44% of participants achieved at least a 2 point reduction in both pain intensity and interference. A similar pattern held for percent pain reduction. At the end of treatment (EoT) relative to pre-treatment, the RelieVRx group demonstrated a significantly larger reduction in the PROMIS Depression, PROMIS Sleep Disturbance, Oswestry Disability Score, and Concerns about Pain (largest p = .004). 

With this large sample size, we were able to conduct exploratory sub-groups analysis aimed at identifying participant groups for which the RelieVRx program is especially advantageous. We conducted a number of univariate analyses dividing the RelieVRx program and Sham participants into those high or low on each metric using clinically validated thresholds to separate participants. We found that participants above the threshold on baseline pain intensity, pain interference, depression, sleep disturbance, disability and catastrophizing showed a larger pain intensity and pain interference reduction (of at least 2.0 points) than those below the threshold. For Sham, on the other hand, no pain intensity or pain interference reduction met the 2.0 point reduction threshold. This pattern was enhanced when we examined participants above threshold on pairs of baseline measures. Thus, the RelieVRx program appears to be especially effective in patients with severe pain and related disorders.

Results:

We conducted a placebo-controlled randomized clinical trial of the RelieVRx program, an FDA authorized skills-based, pain self-management VR program for cLBP, in a national sample of 1093 individuals with cLBP. This sample was larger, with more severe symptoms, and was more demographically diverse than in our previous RCT.8 We found clinically meaningful pain intensity and pain interference reductions at end of treatment in the RelieVRx group that were statistically larger than in the Sham. The proportion of RelieVRx participants achieving clinically meaningful reductions was also statistically larger in the RelieVRx group than in Sham. In addition, the RelieVRx program led to statistically larger reductions in depression, sleep disturbance, disability and catastrophizing. Exploratory sub-groups analysis suggested that participants with high baseline pain severity, depression, sleep disturbance, disability and catastrophizing showed larger pain intensity and pain interference reductions (at least 2.0 points) than those below the threshold, with no Sham group reaching the 2.0 point threshold. This pattern was enhanced for participants high on pairs of baseline measures. Thus, the RelieVRx program is especially effective in patients with severe pain and related disorders. In-home, easy-to-use immersive VR may expand access to effective and on-demand non-pharmacologic treatments for cLBP.

Conclusions: 1. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: ABlueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press; 2011

2. Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet 2018 Jun 09;391(10137):2368-2383. [CrossRef] [Medline]

3. Williams AC de C, Fisher E, Hearn L, Eccleston C. Psychological therapies for the management of chronic pain (excluding headache) in adults. Vol. 2020, Cochrane Database of Systematic Reviews. 2020.

4. Monticone M, Cedraschi C, Ambrosini E, Rocca B, Fiorentini R, Restelli M, et al. Cognitive-behavioural treatment for subacute and chronic neck pain. Vol. 2015, Cochrane Database of Systematic Reviews. 2015.

5. Medicaid Strategies for Non-Opioid Pharmacologic and NonPharmacologic Chronic Pain Management. 2019. URL: https://www.medicaid.gov/sites/default/files/federal-policy-guidance/downloads/cib022219.pdf [accessed 2021-02-03]

6. CMS Interagency report: U.S. Department of Health and Human Services (2019, May). Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health and Human Services website: https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf

7. Darnall BD, Scheman J, Davin S, Burns JW, Murphy JL, Wilson AC, et al. Pain Psychology: A Global Needs Assessment and National Call to Action. Pain Med 2016 Feb 23;17(2):250-263

8. Garcia L, Birckhead B, Krishnamurthy P, Sackman J, Mackey I, Louis R, Salmasi V, Maddox T, Darnall B An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19 J Med Internet Res 2021;23(2):e26292 URL: https://www.jmir.org/2021/2/e26292 DOI: 10.2196/26292.

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