title: Exercise and self-management for people with chronic knee, hip or lower back pain: a cluster randomised controlled trial of clinical and cost-effectiveness. Study protocol.
abstract: OBJECTIVE
  Chronic musculoskeletal pain and osteoarthritis can significantly limit the functional independence of individuals, and given that 25% of the population experience these problems, the socioeconomic impact is immense. Exercise and self-management have proven benefits for these conditions, but most trials tailor interventions for specific joints. Epidemiological data demonstrates that many older people with degenerative joint problems experience pain and functional difficulty in other joints, seeking further healthcare input when these present. Managing multiple joint presentations simultaneously could potentially reduce the need for repeat visits to healthcare professionals as advice is frequently the same for differing site presentations. This single-blind cluster randomised controlled trial will determine the clinical and cost-effectiveness of an exercise and self-management intervention delivered to people over-50 with either hip, knee or lower back pain, compared to 'standard' GP care. A qualitative analysis will also establish the acceptability of the intervention.
  
  
  METHODS
  352 people with chronic degenerative musculoskeletal pain of the hip, knee or lower back will be recruited from primary care. GP surgeries will be randomised to either the intervention or control arms. Participants in the intervention arm will receive a 6-week group exercise and self-management programme facilitated by a physiotherapist in primary care. Participants allocated to the control arm will continue under 'standard' GP care. The primary outcome measure is the Dysfunction Index of the Short Musculoskeletal Functional Assessment (SMFA).
  
  
  METHODS
  Individual patient responses will be modelled using a mixed effects linear regression, allowing for the clustering effects. Resource use and related intervention costs will be estimated and broader resource use data will be collected using a version of the Client Service Receipt Inventory adapted for musculoskeletal relevance. In addition, a cost-utility analysis will be undertaken to present an estimate of the incremental cost per QALY. A qualitative analysis investigating the acceptability of the intervention to participants and healthcare professionals will also be undertaken and thematically analysed.
  
  
  BACKGROUND
  Ethical approval was received from South West 4 REC, identification number 11/SW/0053. Study findings will be disseminated via conference and journal presentation; via arthritis charitable organisations; and through local GP consortia.
authors.affiliation: Faculty of Health & Life Sciences, University of the West of England, Bristol, United Kingdom. Electronic address: nicola.walsh@uwe.ac.uk.
authors.forename: Nicola
authors.initials: N
authors.lastname: Walsh
authors.forename: Fiona
authors.initials: F
authors.lastname: Cramp
authors.forename: Shea
authors.initials: S
authors.lastname: Palmer
authors.forename: Jon
authors.initials: J
authors.lastname: Pollock
authors.forename: Lisa
authors.initials: L
authors.lastname: Hampson
authors.forename: Rachael
authors.initials: R
authors.lastname: Gooberman-Hill
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.forename: Louise
authors.initials: L
authors.lastname: Jones
authors.forename: Sonia
authors.initials: S
authors.lastname: Phillips
authors.forename: Liz
authors.initials: L
authors.lastname: Johnson
authors.forename: Mike
authors.initials: M
authors.lastname: Hurley
mesh_terms: D059350:Chronic Pain / Q000534:rehabilitation / Q000628:therapy*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy; D006621:Hip Joint; D006801:Humans; D007719:Knee Joint; D017116:Low Back Pain / Q000534:rehabilitation / Q000628:therapy*; D059352:Musculoskeletal Pain / Q000534:rehabilitation / Q000628:therapy*; D012648:Self Care; D016037:Single-Blind Method