Virtual reality (VR) interventions have previously demonstrated a therapeutic promise for acute pain, but few studies have examined the effects of this relatively new approach to chronic pain. In a recent article published in BMJ Open, a team of researchers presented a study protocol for a trial evaluating the effectiveness of 3 forms of VR interventions in patients with chronic prevalent low back pain (cLBP).
In the Back Pain Consortium (BACPAC) VR trial proposed by the National Institutes of Health (NIH) (ClinicalTrials.gov identifier: NCT04409353), the study researchers plan to randomly assign a total of 360 patients with cLBP in 3 different VR intervention arms.
The first skill-based VR intervention will incorporate principles of conscious 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 to distract patients from chronic pain. Finally, the third VR simulation control group will make two-dimensional non-immersive videos using a virtual reality headset.
Study researchers will monitor participants for a total of 12 weeks. They will use the results reported by the patient, as well as portable sensor data and electronic health record data as primary data for control. The researchers will then evaluate and compare changes in the pain interference scale (PROMIS) of the Pain Information System (POMIS) of the Patient Reporting Information System (NIH) over the period weeks.
In addition, the study’s researchers hope to evaluate changes in the PROMIS Anxiety and PROMIS sleep disturbance scales, opioid prescription, and short-form scales of the pain catastrophe scale as secondary outcomes. Patient-level VR efficacy predictors will also be explored in a subgroup analysis.
A total of 96 participants were randomly assigned to the virtual reality intervention arms in May 2021. The protocol for this study was created in collaboration with an advocate for the patient with chronic pain. Recruitment for the trial began in September 2020 and, according to researchers in the study, is expected to end someday in September 2023.
Birckhead B, Eberlein S, Alvarez G, et al. Home-based virtual reality for chronic pain: protocol for a randomized controlled trial supported by NIH. BMJ Open. 2021; 11 (6): e050545. doi: 10.1136 / bmjopen-2021-050545