Papers of the Week

Adults with chronic low back pain, disability, moderate to severe pain, and high fear of movement and re-injury were recruited into a trial of a novel, automated, digital therapeutics, virtual reality, psychological intervention for pain (DTxP). We conducted a three-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 6-8 weeks, after which, the standard care control arm were re-randomized to receive either the DTxP or sham placebo. Forty-two participants completed assessments at baseline, immediately post-treatment (6-8 weeks), 9-week, and 5-month follow-up. We found 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 post-treatment or follow-up. When compared to 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 post-treatment. The sham placebo group also reported lower disability and fear of movement at 5-month follow-up compared to 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.