Elsevier

Physiotherapy

Volume 100, Issue 1, March 2014, Pages 54-60
Physiotherapy

Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial

https://doi.org/10.1016/j.physio.2013.06.001Get rights and content

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.

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

References (23)

  • J. Williams et al.

    Measuring shoulder function with the shoulder pain and disability index

    J Rheumatol

    (1995)
  • Cited by (0)

    View full text