Chris Littlewood1,2, Julia Wade3, Stephanie Butler-Walley4,5, Martyn Lewis4,5, David Beard6, Amar Rangan6,7, Gev Bhabra8, Socrates Kalogrianitis9, Cormac Kelly10, Saurabh Mehta11, Harvinder Pal Singh12, Matthew Smith13, Amol Tambe14, James Tyler15, Nadine E Foster4. 1. School of Primary, Community and Social Care, Keele University, Staffordshire, UK. c.littlewood@mmu.ac.uk. 2. Department of Health Professions, Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, UK. c.littlewood@mmu.ac.uk. 3. Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. 4. School of Primary, Community and Social Care, Keele University, Staffordshire, UK. 5. Keele Clinical Trials Unit, Keele University, Keele, UK. 6. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. 7. Department of Health Sciences & Hull York Medical School, University of York, York, UK. 8. University Hospitals Coventry & Warwickshire, Coventry, UK. 9. Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. 10. The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, UK. 11. Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Stoke, UK. 12. Leicester Shoulder Unit, University Hospitals of Leicester NHS Trust, Leicester, UK. 13. The Liverpool Upper Limb Unit, The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. 14. Derby Shoulder Unit, University Hospitals Derby & Burton NHS Foundation Trust, Derby, UK. 15. Airedale General Hospital, Airedale NHS Foundation Trust, Keighley, UK.
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. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04027205 ) - Registered on 19 July 2019. Available via.
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. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04027205 ) - Registered on 19 July 2019. Available via.
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