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

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.

Trial registration: ClinicalTrials.gov NCT04225884.

Conflict of interest statement

The authors have no conflicts of interest to declare.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.

Figures

Figure 1.
Figure 1.
Study design.
Figure 2.
Figure 2.
Exploring the “cabin” inside space used for the Digital Therapeutics for Pain (DTxP) intervention and the sham intervention. The participant in this image was a member of the design team demonstrating the environments, not study participant.
Figure 3.
Figure 3.
Exploring the outside space used for the Digital Therapeutics for Pain (DTxP) intervention and the sham intervention. The participant in this image was a member of the design team demonstrating the environments, not study participant.
Figure 4.
Figure 4.
CONSORT Flow diagram.
Figure 5.
Figure 5.
Tampa Scale of Kinesiophobia scores between groups.
Figure 6.
Figure 6.
Game Experience Questionnaire at posttreatment.
Figure 7.
Figure 7.
Modified Game experience Questionnaire at posttreatment.

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