Optimising management of complex regional pain syndrome to improve clinical outcomes throughout the therapy care pathway in England: Protocol for a qualitative interview and observational study with patients and clinicians

Introduction: Complex Regional Pain Syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. Guidelines recommend early referral for therapies that promote movement of the painful limb. However, evidence suggests a lack of defined therapy pathways for CRPS. Aims: The current study aims to explore CRPS therapy management in centres of excellence in England, and outside of these settings, to understand what facilitates and hinders best practice. The overall aim is to develop a draft stratified package of care to expedite patient access to optimal CRPS therapy across the management pathway. Methods and Analysis: Semi-structured interviews will be conducted with therapists working in CRPS centres of excellence and with therapists in other settings. Observations of therapy interventions in CRPS centres of excellence and interviews with patients who have received this care, will also help to identify potential key care package components. Interview data will be analysed using thematic analysis, mapped to the Theoretical Domains Framework (TDF), and Intervention Mapping Adapt (IMA) framework. Observations will be described and documented using the TDF headings. Conclusion: A triangulation protocol for qualitative health research will be used to integrate all data. Online stakeholder events will be held using consensus methods to agree a draft package of care for future implementation following further refinement, testing and evaluation. Clinical Trial Registration: The trial was registered with ISRCTN registry on 24 February 2022 (ISRCTN16917807)