Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study)
Abstract Background Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed,...
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BMC
2019-06-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-019-3407-3 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Chris Littlewood Marcus Bateman Kendra Cooke Susie Hennnings Tina Cookson Kieran Bromley Martyn Lewis Lennard Funk Jean Denton Maria Moffatt Rachel Winstanley Saurabh Mehta Gareth Stephens Lisa Dikomitis Linda Chesterton Nadine E. Foster |
spellingShingle |
Chris Littlewood Marcus Bateman Kendra Cooke Susie Hennnings Tina Cookson Kieran Bromley Martyn Lewis Lennard Funk Jean Denton Maria Moffatt Rachel Winstanley Saurabh Mehta Gareth Stephens Lisa Dikomitis Linda Chesterton Nadine E. Foster Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study) Trials Rehabilitation Physiotherapy Exercise Rotator cuff Shoulder Randomised controlled trial |
author_facet |
Chris Littlewood Marcus Bateman Kendra Cooke Susie Hennnings Tina Cookson Kieran Bromley Martyn Lewis Lennard Funk Jean Denton Maria Moffatt Rachel Winstanley Saurabh Mehta Gareth Stephens Lisa Dikomitis Linda Chesterton Nadine E. Foster |
author_sort |
Chris Littlewood |
title |
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study) |
title_short |
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study) |
title_full |
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study) |
title_fullStr |
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study) |
title_full_unstemmed |
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study) |
title_sort |
protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the racer study) |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-06-01 |
description |
Abstract Background Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this. Methods/design RaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions. Discussion Research to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation. Trial registration ISRCTN Registry, 18357968. Registered on 10 August 2018. |
topic |
Rehabilitation Physiotherapy Exercise Rotator cuff Shoulder Randomised controlled trial |
url |
http://link.springer.com/article/10.1186/s13063-019-3407-3 |
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doaj-37731fb110484ef1bb34c30d4a5de3bb2020-11-25T04:02:12ZengBMCTrials1745-62152019-06-0120111210.1186/s13063-019-3407-3Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study)Chris Littlewood0Marcus Bateman1Kendra Cooke2Susie Hennnings3Tina CooksonKieran Bromley4Martyn Lewis5Lennard Funk6Jean Denton7Maria Moffatt8Rachel Winstanley9Saurabh Mehta10Gareth Stephens11Lisa Dikomitis12Linda Chesterton13Nadine E. Foster14Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and Keele Clinical Trials Unit, Keele UniversityDerby Shoulder Unit, University Hospitals Derby & Burton NHS Foundation TrustArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and Keele Clinical Trials Unit, Keele UniversityArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and Keele Clinical Trials Unit, Keele UniversityArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and Keele Clinical Trials Unit, Keele UniversityArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and Keele Clinical Trials Unit, Keele UniversityWrightington, Wigan and Leigh NHS Foundation TrustThe Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation TrustWrightington, Wigan and Leigh NHS Foundation TrustRoyal Stoke University Hospital, University Hospitals of North Midlands NHS TrustRoyal Stoke University Hospital, University Hospitals of North Midlands NHS TrustThe Royal Orthopaedic Hospital NHS Foundation TrustArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and School of Medicine, Keele UniversityArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and School of Medicine, Keele UniversityArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences and Keele Clinical Trials Unit, Keele UniversityAbstract Background Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this. Methods/design RaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions. Discussion Research to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation. Trial registration ISRCTN Registry, 18357968. Registered on 10 August 2018.http://link.springer.com/article/10.1186/s13063-019-3407-3RehabilitationPhysiotherapyExerciseRotator cuffShoulderRandomised controlled trial |