title: 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).
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN52269669.
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG, UK. a.bishop@keele.ac.uk.
authors.forename: Annette
authors.initials: A
authors.lastname: Bishop
authors.forename: Gwenllian
authors.initials: G
authors.lastname: Wynne-Jones
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Lawton
authors.forename: Danielle
authors.initials: D
authors.lastname: van der Windt
authors.forename: Chris
authors.initials: C
authors.lastname: Main
authors.forename: Gail
authors.initials: G
authors.lastname: Sowden
authors.forename: A Kim
authors.initials: AK
authors.lastname: Burton
authors.forename: Martyn
authors.initials: M
authors.lastname: Lewis
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.forename: Tom
authors.initials: T
authors.lastname: Sanders
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Hay
authors.forename: Nadine E
authors.initials: NE
authors.lastname: Foster
mesh_terms: D000041:Absenteeism; D019090:Case Management; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D004739:England; D058006:General Practice; D017048:Health Care Costs; D006801:Humans; D059352:Musculoskeletal Pain / Q000175:diagnosis / Q000191:economics / Q000628:therapy*; D009784:Occupational Diseases / Q000175:diagnosis / Q000191:economics / Q000628:therapy*; D009786:Occupational Health Services / Q000191:economics; D011320:Primary Health Care / Q000191:economics; D019057:Quality-Adjusted Life Years; D012107:Research Design; D018582:Sick Leave; D013997:Time Factors; D016896:Treatment Outcome