Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study)

Chris Littlewood*, Julia Wade, Stephanie Butler-Walley, Martyn Lewis, David Beard, Amar Rangan, Gev Bhabra, Socrates Kalogrianitis, Cormac Kelly, Saurabh Mehta, Harvinder Singh, Matthew Smith, Amol Tambe, James Tyler, Nadine Foster

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Abstract

Background
Clinically, a distinction is made between types of rotator cuff tear, traumatic and non-traumatic, and this sub-classification currently informs the treatment pathway. It is currently recommended that patients with traumatic rotator cuff tears are fast tracked for surgical opinion. However, there is uncertainty about the most clinically and cost-effective intervention for patients with traumatic rotator cuff tears and further research is required.
SPeEDy will assess the feasibility of a fully powered, multi-centre randomised controlled trial (RCT) to test the hypothesis that, compared to surgical repair (and usual post-operative rehabilitation), a programme of physiotherapist-led exercise is not clinically inferior, but is more cost-effective for patients with traumatic rotator cuff tears.

Methods
SPeEDy is a two-arm, multi-centre pilot and feasibility RCT with integrated Quintet Recruitment Intervention (QRI) and further qualitative investigation of patient experience. A total of 76 patients with traumatic rotator cuff tears will be recruited from approximately eight UK NHS hospitals and randomly allocated to either surgical repair and usual post-operative rehabilitation or a programme of physiotherapist-led exercise. The QRI is a mixed-methods approach that includes data collection and analysis of screening logs, audio recordings of recruitment consultations, interviews with patients and clinicians involved in recruitment, and review of study documentation as a basis for developing action plans to address identified difficulties whilst recruitment to the RCT is underway. A further sample of patient participants will be purposively sampled from both intervention groups and interviewed to explore reasons for initial participation, treatment acceptability, reasons for non-completion of treatment, where relevant, and any reasons for treatment crossover.

Discussion
Research to date suggests that there is uncertainty regarding the most clinically and cost-effective interventions for patients with traumatic rotator cuff tears. There is a clear need for a high-quality, fully powered, RCT to better inform clinical practice. Prior to this, we first need to undertake a pilot and feasibility RCT to address current uncertainties about recruitment, retention and number of and reasons for treatment crossover.
Original languageEnglish
Article number17
Number of pages11
JournalPilot and Feasibility Studies
Volume7
Issue number1
DOIs
Publication statusPublished - 7 Jan 2021

Bibliographical note

Funding Information:
The authors acknowledge the support of Stacey Lalande, Aidan O?Shea, Karen Larsen, Larry Koyoma, Laura Hedley, Elaine Wilmore, Ellie Richardson, Gordon Smith, James Roberts, Rachel Winstanley, Catrin Astbury, Lisa Pitt, Andrew Cuff and members of the Research User Group from the Primary Care Centre Versus Arthritis, Keele University who contributed to the development of the physiotherapist-led exercise intervention. This study is sponsored by University Hospitals of Derby and Burton NHS Foundation Trust.

Funding Information:
The authors acknowledge the support of Stacey Lalande, Aidan O’Shea, Karen Larsen, Larry Koyoma, Laura Hedley, Elaine Wilmore, Ellie Richardson, Gordon Smith, James Roberts, Rachel Winstanley, Catrin Astbury, Lisa Pitt, Andrew Cuff and members of the Research User Group from the Primary Care Centre Versus Arthritis, Keele University who contributed to the development of the physiotherapist-led exercise intervention. This study is sponsored by University Hospitals of Derby and Burton NHS Foundation Trust.

Funding Information:
CL is supported by a National Institute for Health Research Post-Doctoral Fellowship (PDF-2018-11-ST2-005) for this research project.

Publisher Copyright:
© 2021, The Author(s).

Keywords

  • Surgery
  • Physiotherapy
  • Exercise
  • Rotator cuff tear
  • Shoulder
  • Randomised controlled trial

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