Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial
Introduction
Rotator cuff tendinopathy is regarded as a common and burdensome source of shoulder pain with prevalence estimated to be as high as 14% in the general working-age population [1]. Impaired shoulder function impacts significantly upon activities of daily living, including eating, dressing and working [2]. The course of rotator cuff tendinopathy, for a significant proportion of sufferers, is characterised by persistent pain and/or disability and/or recurrent episodes [3]. Costs in the first 6 months following primary care contact have been estimated to be €690 per person which means that costs attributable to shoulder pain in the United Kingdom are in the region of €345 million or £310 million per year [4], [5].
A range of interventions, both conservative and surgical, are currently used to treat this condition [5]. Although the mechanism of action is poorly understood [6], the potential benefits of loaded exercise, i.e. exercise against gravity or resistance, in comparison to other conservative or surgical treatment strategies have been reported in a systematic review [7]. However, this review, which included four studies regarded as presenting a low risk of bias, recognised the paucity of evidence and other methodological limitations of the evidence base, including no treatment control groups and a lack of use of validated outcome measures, when drawing this conclusion and subsequently recommended that further high-quality research should be conducted.
In keeping with the findings of the systematic review by Littlewood et al. [7], the purpose of this study was to pilot the methods proposed to conduct a substantive randomised controlled trial (RCT) to evaluate the effectiveness of a self-managed exercise programme versus usual physiotherapy treatment for rotator cuff disorders/tendinopathy.
Section snippets
Aims and objectives
The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the clinical and cost-effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. The objectives were to evaluate:
- a.
The process of recruitment and retention rates
- b.
Willingness of participants to be randomised
- c.
The extent of contamination between treatment groups
- d.
Participant adherence with treatment.
A secondary aim was to undertake a
Results
Fig. 1 shows the study profile; 45 people were assessed for eligibility and 30 (67%) of these were potentially eligible for the study. Only one out of 45 (2%) declined to participate due to an unwillingness to be randomised. Twenty-four participants were randomly assigned to the self-managed exercise or usual physiotherapy treatment groups. The mean age at baseline of the participants was 63.2 years (range 44–79) and 50% (12/24) were male. The mean duration of symptoms was 38.6 months (range 3
Discussion
The primary aim of this study was to pilot the research methods and self-managed exercise intervention proposed for a substantive study. With reference to the specific objectives of the pilot study; a) recruitment was to target and retention rates were excellent; b) the vast majority of participants were willing to be randomised; c) contamination was minimal, and; d) exercise adherence rates were excellent. Finally, the outcome measures used were acceptable, in terms of 100% completion at three
Conclusion
Disorders of the rotator cuff are a burdensome problem and there is a clear evidence deficit in relation to conservative management and specifically self-managed loaded exercise. The research methods employed within this pilot RCT appear to offer a suitable foundation upon which to conduct a substantive study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy treatment for chronic rotator cuff disorders/tendinopathy.
Acknowledgements
This work was funded by the International Mechanical Diagnosis and Research Foundation (IMDTRF) and produced by CL under the terms of a Doctoral Research Fellowship issued by the Secretary of State for Health.
This work has been developed in association with the NIHR Collaboration for Leadership in Applied Health Research & Care (CLAHRC) for South Yorkshire. The NIHR CLAHRC for South Yorkshire acknowledges funding from the NIHR. The views and opinions expressed are those of the authors, and not
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