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Protocol for a scoping review of interventional trials in complex regional pain syndrome: evaluation of adherence to the core outcome set, SPIRIT-PRO and CONSORT-PRO guidelines

bmjopen · 2026-05-14 · canonical JSON source

8 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction Complex regional pain syndrome (CRPS) is a debilitating chronic pain condition that severely reduces quality of life. Physiotherapy is a key component of management; however, high-quality evidence to inform optimal practice is limited. Variability in outcome measurement and poor reporting quality may hinder the ability to synthesise findings and inform best practice.Although international guidelines for reporting patient-reported outcomes (PROs) have been developed to address these issues and a CRPS Core Outcome Set (COS) has been published, the extent to which they have been adopted in CRPS research remains unclear. This protocol describes a scoping review, which aims to explore whether randomised controlled trials evaluating physiotherapy interventions for adults with CRPS adhere to COS recommendations and comply with PRO reporting guidelines.Methods and analysis The design of the scoping review will align with the Joanna Briggs Institute methodology. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews will be used to guide reporting. Electronic databases including MEDLINE, CINAHL, Embase, CENTRAL and PsycINFO will be searched in addition to the WHO International Clinical Trials Registry Platform (WHO-ICTRP). Titles, abstracts and full texts will be screened by two independent reviewers. Data extraction and synthesis will follow, with discrepancies resolved through discussion with a third reviewer. Adherence to the CRPS COS will be assessed by mapping trial outcomes to COS domains, and compliance with Standard Protocol Items Recommendations for Interventional Trials: Patient-Reported Outcome Extension (SPIRIT-PRO) and Consolidated Standards of Reporting Trials: PRO Extension (CONSORT-PRO) guidelines will be evaluated against checklist items. Data will be summarised descriptively, with subgroup analysis comparing trials initiated before and after COS publication.Ethics and dissemination Ethical approval is not required as the study involves no collection of primary data. Findings will be disseminated via peer-reviewed journals, conference presentations and concise reports prepared for key stakeholders.Registration This protocol is registered on Open Science Framework and is available at https://doi.org/10.17605/OSF.IO/BFH82.