Placebo-arm RCTs in hand surgery

A recent systematic review identified 63 placebo surgery trials in the literature (Wartolowska 2016). None involved the hand or upper extremity. Placebo interventions are an important methodological option in trial design but face both scientific and ethical challenges. The placebo effect is the perceived therapeutic benefit not attributed to the surgery and leads to an overestimation of the specific (true) effect of the intervention. Before developing hand surgery trials with a placebo arm, it is important to understand patient and surgeon attitudes to them and the potential barriers to implementation.

Question

Is it feasible to conduct a hand surgery randomized controlled trial with a placebo arm?

Plan

The project has three main components:

  1. A national survey of hand surgeons and hand therapists to investigate their beliefs and attitudes towards placebo interventions. This will build on recent placebo surgery surveys from NDORMS (Wartolowska 2014; Baldwin 2016) and use the RSTN / BSSH to enable comprehensive national and international coverage.
  1. Create a priority-setting scheme to identify procedures or interventions patients, surgeons and therapists have most doubt about. These might include surgical procedures such as a simple trapiezectomy for OA or repairing a digital nerve, or interventions such as steroid injections for flexor tenosynovitis or osteoarthritis. After an initial survey, a workshop will be organized to discuss the final candidates.
  1. Patient and public engagement to explore attitudes towards placebo interventions in hand surgery and acceptability of possible trial ideas.

These three streams will run in parallel over one year. A consensus meeting will be held at the end to bring together stakeholders and discuss a definitive trial design.

Register your interest

The project will use¬†similar methodology to the WIRE Study. Collaborators will submit a ‘denominator’ list of all eligible hand surgeons and therapists and be expected to get a high response rate. This will lead to Pubmed citation as a collaborator.

The surveys are currently being finalised. Please register below to express your interest in being a collaborator.



  • Clinician survey
  • University ethics approval
  • Data collection
  • Data analysis
  • Manuscript submission
  • Publication
Matthew D. Gardiner (Chief Investigator)
Centre for OA Pathogenesis
Kennedy Institute of Rheumatology
NDORMS, University of Oxford

Pragash Kamalathevan
Foundation Trainee

Cushla Cooper
Research Manager
SITU
NDORMS, University of Oxford

Jonathan Cook
Associate Professor, Deputy Director
SITU
NDORMS, University of Oxford

Tonia Vincent
Professor of Experimental Rheumatology
Centre for OA Pathogenesis
Kennedy Institute of Rheumatology
NDORMS, University of Oxford

David Beard
Professor and Co-director of SITU
NDORMS, University of Oxford

Abhilash Jain
Associate Professor in Plastic Surgery
NDORMS, University of Oxford

Collaborators will be listed here in due course.
Surgical Interventions Trials Unit (SITU), NDORMS, University of Oxford
£10K British Society for Surgery of the Hand Research Grant 2016
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