Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial

Abstract

IntroductionChronic pain is highly prevalent and associated with a large burden of illness; there is a pressing need for safe, home-based, non-pharmacological, interventions. Virtual reality (VR) is a digital therapeutic known to be effective for acute pain, but its role in chronic pain is not yet fully elucidated. Here we present a protocol for the National Institute of Health (NIH) Back Pain Consortium (BACPAC) VR trial that evaluates the effectiveness of three forms of VR for patients with chronic lower back pain (cLBP), a highly prevalent form of chronic pain.Methods and analysisThe NIH BACPAC VR trial will randomise 360 patients with cLBP into one of three arms, each administered through a head-mounted display: 1) skills-based VR, a program incorporating principles of cognitive behavioural therapy, mindful meditation and physiological biofeedback therapy using embedded biometric sensors; 2) distraction-based VR, a program using 360-degree immersive videos designed to distract users from pain; and 3) sham VR, a non-immersive program using two-dimensional videos within a VR headset. Research participants will be monitored for 12 weeks using a combination of patient-reported outcomes administered via REDCap (Research Electronic Data Capture), wearable sensor data collected via Fitbit Charge 4 and electronic health record data. The primary outcome will be the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale. Secondary outcomes will include PROMIS Anxiety, PROMIS Sleep Disturbance, opioid prescription data and Pain Catastrophizing Scale Short Form. A subgroup analysis will explore patient level predictors for VR efficacy.Ethics and disseminationEthics approval was obtained from the Institutional Review Board of Cedars-Sinai Health System in April 2020. The results will be disseminated in a peer-reviewed journal.Trial registration numberNCT04409353.

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

“…These results add to the emerging RCT evidence base for the potential utility of VR as a tool to deliver psychological interventions in a physical rehabilitation context. 4,12,23–25,61 This is the first such demonstration of a fully automated system.…”

“…Although there are many reports of VR for analgesia 30,49,56 and sedation, 54 there are few examples of attempted use in chronic pain. 34 Notable exceptions include randomized controlled trials of skills-based interventions with a focus on emotional self-regulation 4,12,24,25 and rehabilitation interventions with a focus on education and increasing movement. 23,61 We designed, developed, and tested a VR intervention for use in adults with chronic pain who have high disability and high fear of movement and reinjury.…”

A virtual reality home-based training for the management of stress and anxiety among healthcare workers during the COVID-19 pandemic: study protocol for a randomized controlled trial

“…In our study, healthcare workers will access the VR training directly in their homes and at times that are most convenient for them. Data collected by this study will offer helpful insights on the efficacy and acceptability of VR-based training, which represents an interesting new way to offer remote pisco support and which could facilitate treatment adherence compared to face-to-face VR interventions [ 61 – 63 ]. Importantly, in this study, we will use VR standalone systems, which, compared to other types of immersive systems that are easy to use even at home, such as mobile ones, offer a higher quality experience with more possibilities for interaction.…”

“…Healthcare workers may be unable or reluctant to participate in face-to-face sessions to use VR, especially at times of crisis, primarily due to workload and variable schedules [ 60 ]. Importantly, recent standalone VR systems have made this technology feasible for everyday in-home use [ 61 ]. Thanks to this fact, home-based VR programs represent new promising interventions for remote psychological support [ 61 – 63 ], including relaxation training [ 64 , 65 ].…”

“…Importantly, recent standalone VR systems have made this technology feasible for everyday in-home use [ 61 ]. Thanks to this fact, home-based VR programs represent new promising interventions for remote psychological support [ 61 – 63 ], including relaxation training [ 64 , 65 ]. The second main limitation of VR interventions tested by previous studies is related to their content [ 58 , 59 ].…”