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Abstract
Introduction Exercise therapy is the treatment of choice for the management of patients with shoulder subacromial pain. However, we do not know whether a tailored rehabilitation programme is more effective than a standardised strengthening programme. The aim of this feasibility trial is to assess: (1) participant recruitment rate, (2) the proportion of participants enrolled from the total number screened, (3) adherence to the rehabilitation programme, (4) drop-out rates, (5) obtain estimates of adverse reactions to treatment, (6) obtain estimates of intervention effects in order to inform the sample size of the fully-powered randomised controlled trial, (7) conduct a preliminary cost-effectiveness analysis of the standardised strengthening and the tailored rehabilitation interventions.
Methods The MAnagement of Subacromial disorders of The shouldER (MASTER) trial, is a two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial. Participants will be randomly allocated into one of the interventions group: tailored or standardised rehabilitation. To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. To determine whether it is feasible to conduct the full trial, we will consider 75% CI as the probability threshold at 3-month follow-up.
Ethics and dissemination This study was approved by the University of Otago Ethics Committee (Ref: H17/080). Findings from this study will be presented at national and international conferences, and will be submitted for publication in a peer-reviewed journal.
Trial registration number ANZCTR: 12617001405303
- shoulder
- rehabilitation
- manual therapy
- randomised controlled trial
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Footnotes
Contributors DCR and ZJT conceived the research question. DCR was responsible for the design of the trial, and is the guarantor. ZJT and GS contributed to the design of interventions. JHA provided guidance on the design the trial and economic analysis. DCR led efforts for securing funding, with the contributions from ZJT, GS and JHA. All authors revised and approved the protocol for the study. All authors revised the manuscript for important content and approved the final version.
Funding This work is supported by Health Research Council New Zealand (Grant number: 17/536). The trial sponsor is the University of Otago. The trial started in August 2017, and is funded until July 2019. This research was conducted during tenure of The Sir Charles Hercus Health Research Fellowship of the Health Research Council of New Zealand (Grant number: 18/111) awarded to DCR. The Health Research Council – New Zealand had no role in the design of the trial and will have no role in its execution, data analysis and interpretation, or on the submission of the studies for publication.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval University of Otago Ethics Committee (Ref: H17/080).
Provenance and peer review Not commissioned; externally peer reviewed.