OptiMeth-CRPS: A Methodological Framework for Optimising Clinical Trial Methods for Complex Regional Pain Syndrome (CRPS)

Complex regional pain syndrome (CRPS) is a rare and disabling pain disorder. Systematic reviews have identified a critical lack of adequately powered, high quality clinical trial evidence to inform the management of CRPS. There is an urgent need to find solutions to the methodological challenges of undertaking clinical trials in CRPS. The aim of the ‘Optimising clinical trial methods for complex regional pain syndrome’ (OptiMeth-CRPS) network project was to develop a methodological framework for optimising the planning, design, conduct and reporting of future clinical trials in CRPS (OptiMeth-CRPS). We employed an ‘Experience and expertise’ approach to develop a methodological framework. The framework was developed by an international group with expertise in the lived experience of CRPS, CRPS research, clinical trials, CRPS evidence synthesis and rare disease research methods. We used an iterative process of i) online and face-to-face meetings, ii) reviewing and approving meeting notes detailing the group’s discussions and iii) revising draft manuscripts to develop the framework. This white paper presents the discussions and recommendations of the OptiMeth-CRPS network project. The OptiMeth-CRPS methodological framework presents nine key optimisation strategies for improving the planning, design, conduct and reporting of CRPS trials. These include strategies for optimising i) the trial team, ii) research questions, iii) trial governance and management, iv) trial design, v) the trial population, vi) intervention and comparator groups, vii) trial outcomes, viii) data analysis, and xi) openness, transparency and reporting. The OptiMeth-CRPS methodological framework is offered as a tool to support the CRPS research community to undertake high quality clinical trial research and improve the quality of the evidence upon which clinical decisions and guidelines for the management of CRPS are based.