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P-001 - The Promise of In-Home VR-Delivered Skills-Based Therapy for Chronic Low Back Pain: Results from Two Randomized Sham-Controlled Trials

POSTER ABSTRACT
Location:  Exhibit Hall
Abstract Title: The Promise of In-Home VR-Delivered Skills-Based Therapy for Chronic Low Back Pain: Results from Two Randomized Sham-Controlled Trials

Background: 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 available to people with cLBP.5, 6 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.

Purpose/Objectives: The purpose of this research is to summarize the results from two decentralized randomized sham-controlled trials completed by our research group. The first compared a 56-session self-administered in-home Skills-Based VR-delivered program (RelieVRx®) with Sham VR in a small (N < 200), homogeneous, and clinically moderate sample of adults with cLBP.8 The second compared the Skills-Based VR program with Sham VR in a large (N > 1000), demographically diverse and clinically severe sample of adults with cLBP9. In both trials, the Skills-Based VR and Sham VR programs were delivered via the same commercial VR headsets and involved 56 brief (6 minutes per session) daily treatment sessions. This report summarizes the results from these two randomized controlled trials at end-of-treatment and at 12- and 24-months post-treatment. We also report the results from two secondary analyses of the larger sample RCT.


Methods: In our first randomized controlled trial, a national online sample of N=188 individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 were enrolled and randomized 1:1 to one of two 56-session VR-delivered programs: (1) Skills-Based VR (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). In our second randomized controlled trial, a national online sample of N=1093 individuals with self-reported non-malignant low back pain > 3 months duration and with average pain intensity and pain interference > 4/10 were enrolled and randomized 1:1 to the same: (1) Skills-Based VR or (2) Sham VR programs. The fixed-sequence Skills-Based VR-delivered program is an immersive multi-modal, skills-based, pain self-management program that incorporates evidence-based principles of CBT, mindfulness, and pain neuroscience education. In compliance with 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.10 The Sham VR headset displayed 2D nature footage (e.g., wildlife in the savannah). Self-reported data were collected at pre-treatment, twice a week during the treatment, and immediately at the end of treatment.

Results: Garcia et al8 compared Skills-Based VR-delivered therapy with sham in N=188 adults with cLBP that was homogeneous (female: 76%, non-white: 8%, high school or less: 8%) and clinically moderate (baseline pain intensity = 5.1; baseline pain interference = 4.8, disability = within normal range; sleep disturbance = mild)8. Clinically meaningful reductions (≥ 2 points11) in pain intensity (2.2) and pain interference (2.6) were observed for the Skills-Based VR-delivered program that were significantly larger than for Sham. Pain reductions remained at 24-months post-treatment although they were attenuated (pain intensity reduction = 1.2, pain interference reduction = 2.212). Maddox et al9 conducted a similar trial in N=1093 adults with cLBP that was demographically diverse (female: 72%, non-white: 32%, high school or less: 20%) and clinically severe (baseline pain intensity = 6.6; baseline pain interference = 6.2, disability = severe/completely disabled; sleep disturbance = moderate/severe). Clinically meaningful reductions in pain intensity (2.0) and pain interference (2.3) were observed for the Skills-Based VR program that were significantly larger than for Sham. Pain reductions remained at 12-months post-treatment although they were attenuated (pain intensity reduction = 1.7, pain interference reduction = 1.913). Across both studies, therapeutic program engagement was high ranging from 4.7 - 5.4 sessions per week, and device usability received an A+ rating based on the System Usability Scale.

The large sample in the Maddox et al9 trial allows us to conduct secondary analyses. First, we examined the clinical effectiveness, therapeutic program engagement, and VR device usability of Skills-Based VR across several socio-demographic factors. We found that clinical effectiveness, therapeutic program engagement, and VR device usability of Skills-Based VR was generally unaffected by age (< 65 vs. 65+), gender (male vs. female), race/ethnicity (White vs. Black vs. Other), and socioeconomic status (low vs. high), with a few exceptions (age difference for therapeutic program engagement; race/ethnicity difference for device usability)14. Second, we found that higher baseline pain intensity ratings were associated with larger reductions in pain intensity, and that higher baseline pain interference ratings were associated with larger reductions in pain interference following Skills-Based VR therapy15.

Conclusions/Implications for future research and/or clinical care: Across two decentralized, randomized sham-controlled trials that compared a 56-session self-administered in-home Skills-Based VR-delivered program (RelieVRx®) with Sham VR, we found clinically meaningful reductions in pain intensity and pain interference at end-of-treatment that were statistically larger than in the Sham. Long-term clinical effectiveness was observed at 12- and 24-months post-treatment across both trials. The clinical effectiveness, therapeutic program engagement, and VR device usability of Skills-Based VR was generally unaffected by age (< 65 vs. 65+), gender (male vs. female), race/ethnicity (White vs. Black vs. Other), and socioeconomic status (education and income), suggesting that the Skills-Based VR-delivered program mitigates uncertainty about the degree to which underrepresented populations may benefit from home-based digital therapeutics. The clinical effectiveness of Skill-Based VR was enhanced for participants with high baseline levels of pain intensity and pain interference, suggesting that the Skills-Based VR program is especially effective in patients with severe pain.


References: 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.



9. Maddox, T., Oldstone, L., Sparks, C., Sackman, J., Oyao, A., Garcia, L., Maddox, R., Ffrench, K., Garcia, H., Irvin, A., Maislin, D., Keenan, B., Bonakdar, R., & Darnall, BD. At-home virtual reality program for chronic lower back pain: A randomized sham-controlled effectiveness trial in a clinically severe and diverse sample. Mayo Clinic Proceedings: Digital Medicine, 2023;1(4):563-573. URL: https://www.sciencedirect.com/science/article/pii/S2949761223000834.



10. Birckhead B, Khalil C, Liu X, et al. Recommendations for methodology of virtual reality clinical trials in health care by an international working group: Iterative study. JMIR Ment Health. 2019;6(1). doi:10.2196/11973.



11. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2). doi:10.1016/S0304-3959(01)00349-9.



12. Maddox T, Sparks C, Oldstone L, et al. Durable Chronic Low Back Pain Reductions to 24-Months Post-Treatment for An Accessible, 8-Week, In-Home Behavioral Skills-Based Virtual Reality Program: A Randomized Controlled Trial. Pain Medicine. Published online May 23, 2023. doi:10.1093/pm/pnad070



13. Maddox T, Oldstone L, Sackman, J., et al. 12-month results for a randomized sham-controlled effectiveness trial of an in-home skills-based virtual reality program for chronic low back pain. Submitted for publication, 2024.



14. Maddox T, Oldstone L, Sackman, J., et al. Socio-demographic predictors of clinical effectiveness, therapeutic program engagement, and device usability for an in-home virtual reality program for chronic low back pain: Secondary analysis of a randomized controlled trial. Journal of Medical Extended Reality, 2024



15. Maddox T, Oldstone L, Linde-Zwirble, W., et al. Who benefits most from Skills-based VR-delivered therapy? Secondary analysis of a randomized controlled trial in chronic low back pain. Submitted for publication, 2024