title: A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study.
abstract: BACKGROUND
  Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff) are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability.Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise) in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance.
  
  
  METHODS
  A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist's.An economic analysis will be conducted from an NHS and Personal Social Services perspective to evaluate cost-effectiveness and a qualitative investigation will be undertaken to develop greater understanding of the experience of undertaking or prescribing exercise as a self-managed therapy.
  
  
  BACKGROUND
  ISRCTN84709751.
authors.affiliation: School of Health & Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. c.littlewood@sheffield.ac.uk
authors.forename: Chris
authors.initials: C
authors.lastname: Littlewood
authors.forename: Jon
authors.initials: J
authors.lastname: Ashton
authors.forename: Sue
authors.initials: S
authors.lastname: Mawson
authors.forename: Stephen
authors.initials: S
authors.lastname: May
authors.forename: Stephen
authors.initials: S
authors.lastname: Walters
mesh_terms: D059350:Chronic Pain / Q000191:economics / Q000209:etiology / Q000628:therapy; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000191:economics; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care / Q000379:methods; D018579:Patient Selection; D011788:Quality of Life; D017006:Rotator Cuff / Q000473:pathology* / Q000503:physiopathology; D012648:Self Care; D019534:Shoulder Impingement Syndrome / Q000150:complications / Q000191:economics / Q000628:therapy*; D020069:Shoulder Pain / Q000191:economics / Q000209:etiology / Q000628:therapy*; D011795:Surveys and Questionnaires