Optimising clinical trial methods for complex regional pain syndrome: a methodological framework (OptiMeth-CRPS)

Area of Science:

• Pain Medicine
• Clinical Trial Methodology
• Rare Diseases

Background:

• Complex regional pain syndrome (CRPS) is a rare, debilitating pain condition.
• Existing systematic reviews highlight a significant deficit in high-quality clinical trial evidence for CRPS management.
• There is a critical need to overcome methodological hurdles in conducting CRPS clinical trials.

Purpose of the Study:

• To develop a methodological framework, named OptiMeth-CRPS, to optimize future clinical trials in CRPS.
• To enhance the quality and rigor of research investigating CRPS treatments and interventions.

Main Methods:

• An international network of experts, including individuals with lived experience of CRPS, CRPS trialists, evidence synthesists, and rare disease trial methodologists, collaborated on this project.
• A consensus-based approach was employed, involving iterative online and face-to-face meetings, review and approval of meeting minutes, and manuscript revisions.

Main Results:

• The OptiMeth-CRPS framework comprises 9 key optimization strategies designed to elevate the methodological quality of CRPS trials.
• These strategies encompass optimizing the trial team, research questions, governance, design, population, intervention/comparator groups, outcomes, data analysis, and reporting.
• Specific emphasis is placed on strategies tailored to address the unique challenges inherent in conducting clinical trials for individuals with CRPS.

Conclusions:

• A comprehensive methodological framework (OptiMeth-CRPS) for optimizing CRPS clinical trials has been successfully developed.
• This framework is anticipated to empower the CRPS research community to conduct superior clinical trials.
• Implementation of the OptiMeth-CRPS framework has the potential to enhance the evidence base underpinning clinical decisions and management guidelines for CRPS.