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

Abstract

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.

Authors 13

1. Keith Matthew Smart
2. Victoria Abbott-Fleming
3. Frank Birklein
   Affiliation as printed

   Victoria Abbott-Fleming Burning Nights CRPS Support , Derbyshire , United Kingdom (UK

4. Stephen P. Bruehl

   Vanderbilt University Medical Center · University Medical Center of the Johannes Gutenberg University Mainz

   Affiliation as printed

   Department of Anesthesiology , Vanderbilt University Medical Center , Nashville , Tennessee , USA

   Department of Neurology , University Medical Centre , Mainz , Germany

5. Simon Day
   Affiliation as printed

   Chronic Pain Ireland , Carmichael Centre , North Brunswick Street , Dublin , Ireland

6. Michael C Ferraro
7. Sharon Grieve

   University of the West of England · Royal United Hospital · Royal United Hospital Bath NHS Trust

   Affiliation as printed

   Royal United Hospitals Bath NHS Foundation Trust , Combe Park , Bath , UK ; School of Health and Social Wellbeing ,

   University of the West of England , Blackberry Hill , Bristol , UK

8. R.-D Hilgers Aachen Institute of Medical Statistics

   RWTH Aachen University

   Affiliation as printed

   Institute of Medical Statistics , RWTH Aachen University , Aachen , Germany

9. Carolyn Ingram Aachen Institute of Medical Statistics

   RWTH Aachen University · University College Dublin

   Affiliation as printed

   Institute of Medical Statistics , RWTH Aachen University , Aachen , Germany

   UCD School of Public Health , Physiotherapy and Sport Science , University College Dublin , Dublin , Ireland

10. David J. Keene

    University of Exeter

    Affiliation as printed

    Faculty of Health and Life Sciences , Exeter Medical School , University of Exeter , Exeter , UK

11. Franz König

    University of Exeter

    Affiliation as printed

    Faculty of Health and Life Sciences , Exeter Medical School , University of Exeter , Exeter , UK

12. Stavros Nikolakopoulos

    University of Ioannina

    Affiliation as printed

    Department of Psychology , University of Ioannina , Ioannina , Greece

13. Neil Edward O'Connell