A prospective, double-blind, pilot, randomized, controlled trial of an “embodied” virtual reality intervention for adults with low back pain

Abstract

Adults with chronic low back pain, disability, moderate-to-severe pain, and high fear of movement and reinjury were recruited into a trial of a novel, automated, digital therapeutics, virtual reality, psychological intervention for pain (DTxP). We conducted a 3-arm, prospective, double-blind, pilot, randomized, controlled trial comparing DTxP with a sham placebo comparator and an open-label standard care. Participants were enrolled for 6 to 8 weeks, after which, the standard care control arm were rerandomized to receive either the DTxP or sham placebo. Forty-two participants completed assessments at baseline, immediately posttreatment (6-8 weeks), 9-week, and 5-month follow-up. We found that participants in the DTxP group reported greater reductions in fear of movement and better global impression of change when compared with sham placebo and standard care post treatment. No other group differences were noted at posttreatment or follow-up. When compared with baseline, participants in the DTxP group reported lower disability at 5-month follow-up, lower pain interference and fear of movement post treatment and follow-up, and lower pain intensity at posttreatment. The sham placebo group also reported lower disability and fear of movement at 5-month follow-up compared with baseline. Standard care did not report any significant changes. There were a number of adverse events, with one participant reporting a serious adverse event in the sham placebo, which was not related to treatment. No substantial changes in medications were noted, and participants in the DTxP group reported positive gaming experiences.

Body movement as a biomarker for use in chronic pain rehabilitation: An embedded analysis of an RCT of a virtual reality solution for adults with chronic pain

“…The VIRPI study was registered on ClinicalTrials.gov (NCT04225884). The study design was a double blind three-arm prospective, double-blind, randomized controlled trial comparing a digital therapeutics software solution for chronic pain (DTxP), a Sham placebo comparator, both against standard care ( 19 ). Adults with chronic low back pain were recruited from the community between January 2020 to October 2020, screened and then randomly allocated to one of the study arms.…”

“…The DTxP was a fully immersive VR experience with 24 modules (= individual days of intervention) over 6–8 weeks. It took place in a lakeshore environment, and had e.g., behavior change content provided by a virtual disembodied mentor, and physiotherapeutically designed gamified tasks ( 19 ). The Sham placebo comparator was the same VR environment as in the DTxP arm however it contained no behavior change content ( 19 ).…”

“…It took place in a lakeshore environment, and had e.g., behavior change content provided by a virtual disembodied mentor, and physiotherapeutically designed gamified tasks ( 19 ). The Sham placebo comparator was the same VR environment as in the DTxP arm however it contained no behavior change content ( 19 ). These participants were advised to relax while in the same virtual environment as with DTxP.…”

“…The study was conducted fully remotely in 2020 and 2021. The Virtual Reality (VR) intervention was effective in reducing fear of movement, and in improving subjectively reported quality of life when compared to a sham VR comparator and treatment as usual ( 19 ). Important here is that adults experienced about 30 daily sessions of treatment.…”

The Design and Development of an Embodied Semi-Autonomous Mentoring Intelligence (SAMI) for Use in Virtual Reality Interventions, Operationalized for the Self-Management of Chronic Pain

“…In 2019 we developed a Virtual Reality (VR) intervention for adults (>17 years) with chronic low back pain and a high fear of movement, and we investigated its efficacy and safety in a clinical trial (Eccleston et al, 2022). In the fully immersive environment, patients were guided by a virtual mentor who provided health information and tasks to perform.…”