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Open Access Study protocol

Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669)

Annette Bishop1*, Gwenllian Wynne-Jones1, Sarah A Lawton1, Danielle van der Windt1, Chris Main1, Gail Sowden1, A Kim Burton2, Martyn Lewis1, Sue Jowett3, Tom Sanders1, Elaine M Hay1, Nadine E Foster1 and on behalf of the SWAP study team

Author Affiliations

1 Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG, UK

2 Institute for Research in Citizenship and Applied Human Sciences, University of Huddersfield, Huddersfield, UK

3 School of Health and Population Sciences, University of Birmingham, Birmingham, UK

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BMC Musculoskeletal Disorders 2014, 15:232  doi:10.1186/1471-2474-15-232

Published: 10 July 2014

Abstract

Background

Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness.

Methods/Design

This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (nā€‰=ā€‰6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors.

Discussion

This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues.

Trial registration

Current Controlled Trials ISRCTN52269669.

Keywords:
Cluster randomised trial; Musculoskeletal pain; Primary care; Vocational advice; Case management; Work