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)

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 (n = 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.