Poster Number-50 - At-Home Virtual Reality Program for Chronic Low Back Pain: Durability of a Randomized, Placebo-Controlled Trial to 18-months Post-Treatment

Chronic low back pain (CLBP) is the most prevalent chronic pain condition worldwide.1 CLBP can be disabling, costly, and confer suffering to individuals and their families. The incidence and prevalence of CLBP continue to rise despite the increasing use of pharmacological and surgical interventions.2 Pain education and cognitive behavioral therapy (CBT) are recommended as first line treatments for CLBP.3 CBT for chronic pain engages participants in active pain and symptom self-management,4,5,6 sometimes on 1-on-1 sessions and sometimes in group settings, and typically involving 8-12 two-hour treatment sessions (16-24 hours total treatment time). Although CBT is generally effective, access to care remains poor due to barriers such as few trained and available local therapists, health insurance limits, and burdens associated with travel, scheduling, and treatment time.7 There is an urgent need for effective, accessible treatments for the many people who suffer from back pain. On-demand digital therapeutics provide home-based access to pain education and skills-based pain self-management. 

A recent surge of pain mitigation solutions have been developed that utilize virtual reality (VR) headsets. VR provides a unique environment comprising three-dimensional (3D) visually immersive experiences enriched with sounds, colors and scenic environments that facilitate the enhancement and activation of the central nervous system. VR broadly engages multiple pain and learning centers in the brain in synchrony. This has the potential to speed the development of behavioral skills and habits known to be effective at mitigating pain. 
The purpose of the present study is to test the durability of the pain reduction to 18-months post treatment for AppliedVR’s RelieVRx solution, an 8-week, self-administered at-home behavioral skills-based therapeutic VR solution for chronic low back pain. RelieVRx includes VR modules that incorporate principles and elements drawn from CBT, mindfulness and acceptance-based treatments for chronic pain. RelieVRx was compared with an active control that utilized non-immersive VR. We conducted a placebo-controlled RCT in community-based individuals with CLBP assigned to receive therapeutic VR (RelieVRx) or Sham VR8. and found superior outcomes for RelieVRx for all baseline to post-treatment comparisons. In this study we examine durability of effect to 18-months post-treatment.

Methods:

A national online convenience sample of 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 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). 

RelieVRx is an immersive multi-modal, skills-based, pain self-management VR program that incorporates evidence-based principles of CBT, mindfulness, and pain neuroscience education. RelieVRx 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. Durability of the pain treatment effect was evaluated by collecting data on pain intensity and pain-related interference with activity, stress, mood, and sleep at 1, 2, 3, 6, and 18-months post-intervention. Results for the end of treatment, 1, 2, and 3 month durability, and 6-month durability are available in these three peer-reviewed publications. 10, 11, 12

Results:

The study sample was 188 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. At the end of treatment (EoT) relative to pre-treatment, and at 6 months post-treatment relative to pre-treatment, clinically meaningful reductions (i.e., those 30% or greater) in pain intensity (EoT = 42%; 6 mo = 31%), as well as pain interference with activity (EoT = 49%; 5 mo = 35%), sleep (EoT = 52%; 6 mo = 45%), mood (EoT = 56%; 6 mo = 39%), and stress (EoT = 57%; 6 mo = 43%) were observed for the RelieVRx group. These pain reductions were significantly larger than those observed in the Sham VR group for all metrics at both EoT and 6 months post-treatment (all p’s < .05). 

At 18-months post-treatment relative to pre-treatment, clinically meaningful reductions in pain interference with activity (42%), sleep (38%), mood (47%), and stress (48%) were observed for the RelieVRx group. Only pain intensity (26%) did not reach the 30% threshold. These pain reductions were significantly larger than those observed in the Sham VR group for pain intensity and pain interference with activity and stress (p’s < .05). 

To determine whether participants with 30%+ pain reductions at EoT showed durability at 6 or 18 months post-treatment, we computed the percentage of participants who achieved 30%+ reductions at EoT and 6 months post-treatment and the percentage of participants who achieved 30%+ reductions at EoT and 18 months post-treatment. We compared these percentages with those for participants who did not achieve 30% reductions at EoT and 6 months post-treatment and who did not achieve 30% reductions at EoT and 18 months post-treatment.

First, for RelieVRx, nearly half (45%) of participants showed 30%+ pain reductions that were durable to 6 months, whereas only 20% of Sham participants showed the same pattern. For RelieVRx, only 20% of participants do not show 30%+ pain reductions at both EoT and 6 mo, whereas 54% of Sham participants showed this pattern.

Second, for RelieVRx, 1/3rd (33%) of participants showed 30%+ pain reductions that were durable to 18 months, whereas only 6% of Sham participants showed the same pattern. For RelieVRx, only 32% of participants do not show 30%+ pain reductions at both EoT and 18 mo, whereas nearly half (48%) of Sham participants showed this pattern.

Conclusion:

The observed benefit of RelieVRx at 6 months post-treatment in pain-related interference with activity, sleep, mood, and stress persisted at 18 months post-treatment. Only the reduction in pain intensity at 18 months did not persist at the clinically meaningful extent of at least 30% reduction. In addition, nearly half of RelieVRx participants showed clinically meaningful pain intensity reductions at both EoT and 6 months post-treatment, and 1/3rd of RelieVRx participants showed clinically meaningful pain intensity reductions at both EoT and 18 months post-treatment. Clinical outcomes suggest that RelieVRx helps patients develop behavioral skills and habits that are applied outside of the headset. Home-based RelieVRx is an effective, on-demand non-pharmacologic treatment for chronic low back pain with sustained durability of benefits for up to a year and a half after treatment. Future research could investigate whether a booster regimen of RelieVRx may expand the degree and duration of benefit of this novel FDA-authorized treatment for chronic low back pain. 

References:

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. Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, et al. The rising prevalence of chronic lowback pain. Arch Intern Med 2009 Feb 09;169(3):251-258 [FREE Full text] [doi: 10.1001/archinternmed.2008.543] [Medline:19204216]
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10. 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.
11. Garcia L, Birckhead B, Krishnamurthy P, Sackman J, Mackey I, Louis R, Salmasi V, Maddox T, Darnall B Three-month follow-up results of a double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain. Journal of Pain, 23(5), 822-840.
12. Garcia L, Birckhead B, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Castro C, Maddox R, Maddox T, Darnall B
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 J Med Internet Res 2022;24(5):e37480 URL: https://www.jmir.org/2022/5/e37480 DOI: 10.2196/37480