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

Christopher Eccleston, Emma Fisher, Sammeli Liikkanen, Toni Sarapohja, Carina Stenfors, Satu K. Jääskeläinen, Andrew S.C. Rice, Leena Mattila, Taru Blom, J. Raymond Bratty

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
Pages (from-to)1700-1715
Number of pages16
JournalPain
Volume163
Issue number9
Early online date25 Mar 2022
DOIs
Publication statusPublished - 1 Sep 2022

Keywords

  • Chronic low back pain
  • Feasibility study
  • Psychological treatment
  • Randomized controlled trial
  • Virtual reality

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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