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.
摘要：
目标：这项初步研究的主要目的是测试一种新型数字系统原型的可行性和可接受性，该系统可通过游戏化移动应用程序在慢性疼痛患者中进行在家进行体感训练。次要目的是测试干预对临床结果的影响大小，以支持随后的随机对照试验。材料和方法：我们在纤维肌痛患者中进行了一项随机对照试验。这是一项为期8周的交叉研究,其中包括随机顺序的4周体感训练阶段（每天使用新型数字系统）和4周控制阶段（不使用此新系统）。通过客观测量依从性和保留率来测试可行性。通过主观问卷的数据测量疼痛和残疾的可接受性和变化。结果：35例患者完成研究。满意度问卷显示培训享受度较高，便于日常训练和兴趣继续使用干预后的研究。依从性（93％）和保留率（94％）很高。疼痛强度的效应大小适中(0.57)。结论:远程传递体感训练的新型游戏化技术在一组纤维肌痛患者中是可行的,并导致高参与度，满意,和坚持。随后的临床试验与技术平台的最终版本，包括更长的训练，更多的感官训练任务和更大的样本量是必要的。
