Virtual reality (VR) interventions have previously shown therapeutic promise for acute pain, but few studies have examined the effects of this relatively new approach for chronic pain. In a recent paper published in the BMJ Open, a team of researchers presented a study protocol for a trial evaluating the efficacy of 3 forms of VR interventions for patients with highly prevalent chronic lower back pain (cLBP).
In the proposed National Institute of Health (NIH) Back Pain Consortium (BACPAC) VR trial (ClinicalTrials.gov Identifier: NCT04409353), study researchers plan to randomly assign a total of 360 patients with cLBP into 3 different VR intervention arms.
The first skills-based VR intervention will incorporate principles of mindful meditation, cognitive behavioral therapy, and physiological biofeedback with embedded biometric sensors. The second distraction-based VR treatment arm will use 360-degree immersive video content as a means of distracting patients from their chronic pain. Finally, the third sham VR control group will watch nonimmersive, 2-dimensional videos using a VR headset.
Study investigators will monitor participants for a total of 12 weeks. They will use patient-reported outcomes as well as wearable sensor data and electronic health record data as the primary data for monitoring. The investigators will then evaluate and compare changes on the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale during the 12-week period.
Additionally, the study researchers hope to evaluate changes on the PROMIS Anxiety and PROMIS Sleep Disturbance scales, opioid prescription, and Pain Catastrophizing Scale Short Form scores as secondary outcomes. Patient-level predictors of VR efficacy will also be explored in a subgroup analysis.
A total of 96 participants have been randomly assigned to the VR intervention arms as of May 2021. The protocol for this study was created in collaboration with a chronic pain patient advocate. Recruitment for the trial began in September 2020 and, according to the study researchers, is expected to end sometime in September 2023.
Birckhead B, Eberlein S, Alvarez G, et al. Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021;11(6):e050545. doi:10.1136/bmjopen-2021-050545