title: An experienced physiotherapist prescribing and administering corticosteroid and local anaesthetic injections to the shoulder in an Australian orthopaedic service, a non-inferiority randomised controlled trial and economic analysis: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The early management of orthopaedic outpatients by physiotherapists may be useful in reducing public hospital waiting lists. Physiotherapists in Australia are prevented by legislation and funding models from investigating, prescribing, injecting and referring autonomously. This gap in service is particularly noticeable in the management of shoulder pain in early-access physiotherapy services, as patients needing corticosteroid injection face delays or transfer to other services for this procedure. This trial will investigate the clinical (decision making and outcomes) and economic feasibility of a physiotherapist prescribing and delivering corticosteroid and local anaesthetic injections for shoulder pain in an Australian public hospital setting.
  
  
  METHODS
  A double-blinded (patient and assessor) non-inferiority randomised controlled trial will compare an orthopaedic surgeon and a physiotherapist prescribing and delivering corticosteroid injections to the shoulder. Agreement in decision making between the two clinicians will be investigated, and economic information will be obtained for estimating disease burden and an economic evaluation. The surgeon and the physiotherapist will independently assess patients, and 64 eligible participants will be randomised to receive subacromial injection of corticosteroid and local anaesthetic from either the surgeon or the physiotherapist. Post-injection, all participants will receive physiotherapy. The primary outcome measure will be the Shoulder Pain and Disability Index measured at baseline, and at 6 and 12 weeks post-injection. Analysis will be conducted on an intention-to-treat basis and compared to a per-protocol analysis. A cost-utility analysis will be undertaken from the perspective of the health funder.
  
  
  CONCLUSIONS
  Findings will assist policy makers and services in improving access for orthopaedic patients.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Registry: 12612000532808 First registered: 21 May 2012. First participant randomized: 16 January 2013.
authors.affiliation: Gold Cost Hospital and Health Service, Gold Coast University Hospital, 1 Hospital Boulevard, Southport 4215, Gold Coast, Australia. darryn.marks@health.qld.gov.au.
authors.forename: Darryn
authors.initials: D
authors.lastname: Marks
authors.forename: Leanne
authors.initials: L
authors.lastname: Bisset
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
authors.forename: Shaun
authors.initials: S
authors.lastname: O'Leary
authors.forename: Tracy
authors.initials: T
authors.lastname: Comans
authors.forename: Shu Kay
authors.initials: SK
authors.lastname: Ng
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.forename: Paul
authors.initials: P
authors.lastname: Scuffham
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000191:economics; D000553:Ambulatory Care; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000191:economics; D001696:Biomechanical Phenomena; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D004311:Double-Blind Method; D016527:Drug Costs; D005240:Feasibility Studies; D017721:Hospital Costs; D006779:Hospitals, Public; D006801:Humans; D007270:Injections, Intra-Articular; D019637:Orthopedic Procedures / Q000191:economics; D010147:Pain Measurement; D059825:Physical Therapists / Q000191:economics; D026741:Physical Therapy Modalities / Q000191:economics; D011793:Queensland; D020127:Recovery of Function; D012107:Research Design; D012785:Shoulder Joint / Q000187:drug effects* / Q000503:physiopathology; D020069:Shoulder Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000779:Anesthetics, Local