Clinical trials for complex regional pain syndrome rarely recruit adequate numbers of participants to enable robust evaluation of rehabilitation interventions. Innovative methods are required to overcome barriers to identifying, recruiting, treating and retaining participants in rehabilitation trials for CRPS and other rare pain conditions.
We developed a decentralised trial model to identify, screen, randomise, and treat people with CRPS. A targeted social media advertising strategy is used to identify community-dwelling people with complex regional pain syndrome. Interested participants are screened in 3-stages: (i) automated assessment of participant-reported information in REDCap, an online data capture platform; (ii) telephone screening with research staff (iii) and Telehealth-adapted CRPS diagnosis according to the IASP Budapest criteria. Randomisation is done centrally using a web-based platform. Self-report outcome measures are completed via REDCap, including PROMIS computerised adaptive tests to reduce participant burden. The trial intervention, GMI, has been adapted to allow delivery via Telehealth, over seven 60-minute sessions with pain specialist physiotherapists. An online platform (Pathwright) was established to deliver a pain science education module to accompany the GMI intervention.
From May 2021 to October 2 2024, 13,913 people provided initial screening data in REDCap. Of these, 1861 met the broad trial eligibility criteria (diagnosis of CRPS ≤5 years). Research staff made successful phone contact with 1631 people and 262 met the telephone screening criteria. The trial physician screened 222 participants, confirming the Budapest CRPS diagnosis in 142 participants who were then randomised. This represents the largest CRPS trial ever conducted in Australia. The digital advertising cost per CRPS contact was AUD $93, with AUD $1,218 per randomised participant. Most participants (72%) resided in non-metropolitan areas of Australia. GMI session attendance and completeness of outcome data were high (90% and 95%, respectively).
Decentralised trials represent an efficient and cost-effective method for conducting clinical trials of rare pain conditions, enabling larger and more representative samples of participants. Future studies may incorporate use of health records and other instruments to increase robustness of screening processes and improve diagnostic accuracy.
Future rehabilitation trials for rare pain conditions, including CRPS, can implement decentralised models to increase participant recruitment rates, equity of trial access, rehabilitation session attendance, and outcome completeness.
rehabilitation
decentralised trials
