Evidence map›Paper›PMID 41064466›Full record

ArticlePain reports2025

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

Keith M Smart, Victoria Abbott-Fleming, Frank Birklein, Stephen Bruehl, Erica Corcoran, Simon Day, Michael C Ferraro, Sharon Grieve, Ralf-Dieter Hilgers, Carolyn Ingram and 5 more

Abstract read
In one paragraph

Article in Pain reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Keith M SmartUCD School of Public Health, Physiotherapy and Sport Science, University College Dublin, Dublin, Ireland.
Victoria Abbott-FlemingBurning Nights CRPS Support, Derbyshire, United Kingdom.ORCID https://orcid.org/0009-0004-3953-8040
Frank BirkleinDepartment of Neurology, University Medical Centre, Mainz, Germany.ORCID https://orcid.org/0000-0002-6672-4226
Stephen BruehlDepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-2264-4758
Erica CorcoranChronic Pain Ireland, Carmichael Centre, Dublin, Ireland.
Simon DayClinical Trials Consulting and Training Limited, North Marston, Buckinghamshire, United Kingdom.ORCID https://orcid.org/0000-0002-5672-6818
Michael C FerraroCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.ORCID https://orcid.org/0000-0003-0563-1832
Sharon GrieveRoyal United Hospitals Bath NHS Foundation Trust, Combe Park, Bath, United Kingdom.ORCID https://orcid.org/0000-0002-3509-3468
Ralf-Dieter HilgersInstitute of Medical Statistics, RWTH Aachen University, Aachen, Germany.ORCID https://orcid.org/0000-0002-5945-1119
Carolyn IngramUCD School of Public Health, Physiotherapy and Sport Science, University College Dublin, Dublin, Ireland.ORCID https://orcid.org/0000-0002-3789-1463
David J KeeneFaculty of Health and Life Sciences, Exeter Medical School, University of Exeter, Exeter, United Kingdom.ORCID https://orcid.org/0000-0001-7249-6496
Franz KönigCenter for Medical Data Science, Institute for Medical Statistics. Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0002-6893-3304
Candida McCabeSchool of Health and Social Wellbeing, University of the West of England, Blackberry Hill, Bristol, United Kingdom.ORCID https://orcid.org/0000-0002-3593-0027
Stavros NikolakopoulosDepartment of Psychology, University of Ioannina, Ioannina, Greece.ORCID https://orcid.org/0000-0002-9769-3725
Neil E O'ConnellDepartment of Health Sciences, Centre for Wellbeing Across the Lifecourse, Brunel University London, United Kingdom.ORCID https://orcid.org/0000-0003-1989-4537

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Complex regional pain syndrome (CRPS) is a rare, disabling pain disorder. Systematic reviews have identified a critical lack of 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 this project was to develop a methodological framework for optimising future clinical trials in CRPS (OptiMeth-CRPS). Methods: An international network with expertise in the lived experience of CRPS, CRPS trials and evidence synthesis, and rare disease trial methods developed the framework using an "Experience and expertise" approach through an iterative process of (1) online and face-to-face meetings, (2) reviewing and approving meeting notes, and (3) revising draft manuscripts to develop the framework. Results: The OptiMeth-CRPS methodological framework presents 9 key optimisation strategies for improving the methodological quality of CRPS trials. These include strategies for optimising (1) the trial team, (2) research questions, (3) trial governance and management, (4) trial design, (5) the trial population, (6) intervention and comparator groups, (7) trial outcomes, (8) data analysis, and (9) openness, transparency, and reporting. We highlight those optimisation strategies that specifically address the challenges of undertaking clinical trials in people with CRPS. Conclusion: A methodological framework for optimising clinical trials in CRPS has been developed. The OptiMeth-CRPS methodological framework may support the CRPS research community to undertake high-quality clinical trials and improve the quality of the evidence on which clinical decisions and guidelines for the management of CRPS are based.

Indexed as

Clinical trialComplex regional pain syndromeMethodological framework

Identifiers

PMID41064466
PMCPMC12503147

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.