Feasibility study of a home-based sensory training system (STS) device for type 1 complex regional pain syndrome in England: Lessons learnt.

Introduction: Sensory discrimination training has demonstrated improvements in two-point discrimination and pain reduction in people with chronic pain. We tested the feasibility and acceptability of a novel Sensory Training System (STS) device in the homes of people with Type 1 Complex Regional Pain Syndrome (CRPS).

Methods: Participants meeting CRPS diagnostic criteria were invited to use the STS for a minimum of 30 minutes per day for 30 days. Device usage data were captured by the STS. Assessments at baseline and after 30 days were: two-point discrimination ability, pain intensity and interference, sensitivity and emotions towards CRPS limb. Qualitative interviews were conducted at the end of the study to capture participants' feedback on the device.

Results: A total of 10 participants (female n = 7) completed the study. Participants' mean age was 56.4 years (range: 24-78 years), and mean disease duration was 9.37 years (range: 4.25-26.5). Eight had lower limb CRPS. The mean STS device use was 27.3 ± 3.4 days and mean daily usage of training games was 00:27:11 ± 00:07:52 (hh:mm:ss). No patterns or trends were evident between device usage and outcome data.

Conclusion: This feasibility study of a home-based STS for people with CRPS revealed key areas for improvement in the device's hardware and software and outlined the challenges of development and testing during the COVID-19 pandemic, while also capturing valuable usability insights from participant feedback. Key recommendations include early and ongoing collaboration with users, securing sufficient funding, ensuring correct device setup by participants, conducting interim analysis, and using online tools to enhance participant experience and data collection.

Study registration: The study was registered with ISRCTN registry on 28^th May 2021 (https://doi.org/10.1186/ISRCTN89099843).