title: A pilot cluster randomised controlled trial to investigate the addition of direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain: the STEMS pilot trial protocol (ISRCTN23378642).
abstract: BACKGROUND
  Musculoskeletal problems are common, accounting for up to 30 % of general practitioner (GP) consultations and are a major cause of chronic disability worldwide. Demand for health care for musculoskeletal conditions is likely to continue to rise given the ageing population and the increasing impact of these common painful conditions. Physiotherapists are well equipped to deliver evidence-based management for these conditions. Direct access allows patients to access physiotherapy without seeing their GP or another referring practitioner first; however, for most patients in the UK, access to National Health Service physiotherapy is controlled through GP referral.
  
  
  METHODS
  The aim of this pilot, pragmatic, cluster trial is to assess the feasibility of a future large trial to compare the clinical and cost-effectiveness of the additional offer of direct access to physiotherapy versus continuing with usual GP-led primary care alone for adults with common musculoskeletal problems. The pilot will focus on process outcomes to assess feasibility, although performance of the likely outcomes of a main trial will also be assessed. This is a two-arm parallel, cluster RCT where GP practices are the units of randomisation (the clusters), yet data are collected from individual patients with musculoskeletal problems (the participants). A direct access service will be set up in the participating physiotherapy service to provide the option of direct access to patients of the intervention arm practices. Inclusion criteria are broad to reflect the 'real-world' operation of an NHS physiotherapy direct access service for patients with musculoskeletal pain. Data collection will be through patient self-reported questionnaires at baseline, 2, 6 and 12 months and medical record review.
  
  
  CONCLUSIONS
  No previous trials have been conducted into direct access to physiotherapy for patients with musculoskeletal problems. The strengths of the STEMS pilot trial are its size, the length of follow-up, and collection of process, clinical and cost outcomes to fully inform a future main trial to meet calls to provide robust trial evidence of the impact on clinical outcomes, work loss and costs to provide clinicians and service funders with the high quality trial data they need to guide decisions on the best models of care.
  
  
  BACKGROUND
  The STEMS pilot trial is registered at Current Controlled Trials: ISRCTN23378642.
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Annette
authors.initials: A
authors.lastname: Bishop
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Tooth
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Protheroe
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Salisbury
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Reuben O
authors.initials: RO
authors.lastname: Ogollah
authors.affiliation: Health Economics Unit, University of Birmingham, Birmingham, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Hay
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Nadine E
authors.initials: NE
authors.lastname: Foster
keywords: Cluster trial; Direct access; Musculoskeletal; Physiotherapy; Pilot; Self-referral