Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff
NCT04027205 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2021-02-18
Summary
The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.
Conditions
- Traumatic Rotator Cuff Tear
Interventions
- OTHER
-
Physiotherapist-led exercise
A programme of physiotherapist-led exercise over approximately 12 weeks.
- PROCEDURE
-
Surgical repair
Surgical repair of the rotator cuff plus usual post-operative rehabilitation
Sponsors & Collaborators
-
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
University Hospitals of Derby and Burton NHS Foundation Trust
collaborator OTHER -
University Hospitals, Leicester
collaborator OTHER -
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
collaborator OTHER_GOV -
University Hospitals of North Midlands NHS Trust
collaborator OTHER -
University Hospitals Coventry and Warwickshire NHS Trust
collaborator OTHER -
Airedale NHS Foundation Trust
collaborator OTHER -
Liverpool University Hospitals NHS Foundation Trust
collaborator OTHER_GOV -
University Hospital Birmingham NHS Foundation Trust
collaborator OTHER -
Keele University
lead OTHER
Principal Investigators
-
Chris Littlewood, PhD · Manchester Metropolitan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-03
- Primary Completion
- 2021-02-03
- Completion
- 2021-02-03
Countries
- United Kingdom
Study Locations
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