ABSTRACT
Objective: The primary aim of this pilot study was to test the feasibility and acceptability of a prototype of a novel digital system enabling somatosensory training at home by means of a gamified mobile application in patients with chronic pain. The secondary aims were to test the effect size of the intervention on clinical outcomes to power a subsequent randomized controlled trial. Materials and Methods: We conducted a pilot randomized controlled trial in patients with fibromyalgia. This was an 8-week crossover study, which included a 4-week somatosensory training phase (daily use with the novel digital system) and a 4-week control phase (no use of this new system) in a random order. Feasibility was tested by objectively measuring the adherence and retention rates. Acceptability and changes in pain and disability were measured through data from subjective questionnaires. Results: Thirty-five patients completed the study. The satisfaction questionnaire indicated high training enjoyment, ease of use for daily training and interest to continue to use the intervention after the study. The adherence (93%) and retention (94%) rates were high. The effect sizes were moderate for pain intensity (0.57). Conclusion: The novel gamified technology for remotely delivered somatosensory training is feasible in a group of patients with fibromyalgia, and results in high engagement, satisfaction, and adherence. A subsequent clinical trial with the final version of the technology platform, including a longer training with more sensory training tasks and a bigger sample size is necessary.
