Chris Littlewood1, Peter Malliaras2, Sue Mawson3, Stephen May4, Stephen J Walters5. 1. School of Health & Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK. Electronic address: c.littlewood@sheffield.ac.uk. 2. Centre for Sports and Exercise Medicine, Queen Mary, University of London, Mile End Hospital, London, UK. Electronic address: p.malliaras@qmul.ac.uk. 3. Director of the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research & Care (CLAHRC) for South Yorkshire, Sheffield Teaching Hospitals, 11 Broomfield Road, Sheffield S10 2SE, UK. Electronic address: s.mawson@sheffield.ac.uk. 4. Faculty of Health & Wellbeing, Sheffield Hallam University, Sheffield S10 2BP, UK. Electronic address: s.may@shu.ac.uk. 5. School of Health & Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK. Electronic address: s.j.walters@sheffield.ac.uk.
Abstract
OBJECTIVES:Rotator cuff tendinopathy is a common source of shoulder pain characterised by persistent and/or recurrent problems for a proportion of sufferers. The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. DESIGN: A single-centre pragmatic unblinded parallel group pilot randomised controlled trial. SETTING: One private physiotherapy clinic, northern England. PARTICIPANTS: Twenty-four participants with rotator cuff tendinopathy. INTERVENTIONS: The intervention was a programme of self-managed loaded exercise. The control group received usual physiotherapy treatment. MAIN OUTCOMES: Baseline assessment comprised the Shoulder Pain and Disability Index (SPADI) and the Short-Form 36, repeated three months post randomisation. RESULTS: The recruitment target was met and the majority of participants (98%) were willing to be randomised. 100% retention was attained with all participants completing the SPADI at three months. Exercise adherence rates were excellent (90%). The mean change in SPADI score was -23.7 (95% CI -14.4 to -33.3) points for the self-managed exercise group and -19.0 (95% CI -6.0 to -31.9) points for the usual physiotherapy treatment group. The difference in three month SPADI scores was 0.1 (95% CI -16.6 to 16.9) points in favour of the usual physiotherapy treatment group. CONCLUSIONS: In keeping with previous research which indicates the need for further evaluation of self-managed loaded exercise for rotator cuff tendinopathy, these methods and the preliminary evaluation of outcome offer a foundation and stimulus to conduct a substantive study.
RCT Entities:
OBJECTIVES:Rotator cuff tendinopathy is a common source of shoulder pain characterised by persistent and/or recurrent problems for a proportion of sufferers. The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. DESIGN: A single-centre pragmatic unblinded parallel group pilot randomised controlled trial. SETTING: One private physiotherapy clinic, northern England. PARTICIPANTS: Twenty-four participants with rotator cuff tendinopathy. INTERVENTIONS: The intervention was a programme of self-managed loaded exercise. The control group received usual physiotherapy treatment. MAIN OUTCOMES: Baseline assessment comprised the Shoulder Pain and Disability Index (SPADI) and the Short-Form 36, repeated three months post randomisation. RESULTS: The recruitment target was met and the majority of participants (98%) were willing to be randomised. 100% retention was attained with all participants completing the SPADI at three months. Exercise adherence rates were excellent (90%). The mean change in SPADI score was -23.7 (95% CI -14.4 to -33.3) points for the self-managed exercise group and -19.0 (95% CI -6.0 to -31.9) points for the usual physiotherapy treatment group. The difference in three month SPADI scores was 0.1 (95% CI -16.6 to 16.9) points in favour of the usual physiotherapy treatment group. CONCLUSIONS: In keeping with previous research which indicates the need for further evaluation of self-managed loaded exercise for rotator cuff tendinopathy, these methods and the preliminary evaluation of outcome offer a foundation and stimulus to conduct a substantive study.
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