title: Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Osteoporosis and vertebral fracture can have a considerable impact on an individual's quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care.
  
  
  METHODS
  Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year.
  
  
  CONCLUSIONS
  There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown.
  
  
  BACKGROUND
  Reference number ISRCTN49117867.
authors.affiliation: NIHR - BRU, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK. Karen.Barker@ouh.nhs.uk.
authors.forename: Karen L
authors.initials: KL
authors.lastname: Barker
authors.forename: Muhammad K
authors.initials: MK
authors.lastname: Javaid
authors.forename: Meredith
authors.initials: M
authors.lastname: Newman
authors.forename: Catherine
authors.initials: C
authors.lastname: Minns Lowe
authors.forename: Nigel
authors.initials: N
authors.lastname: Stallard
authors.forename: Helen
authors.initials: H
authors.lastname: Campbell
authors.forename: Varsha
authors.initials: V
authors.lastname: Gandhi
authors.forename: Sallie
authors.initials: S
authors.lastname: Lamb
mesh_terms: D002985:Clinical Protocols; D004739:England; D006801:Humans; D058866:Osteoporotic Fractures / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D016103:Spinal Fractures / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D013997:Time Factors; D016896:Treatment Outcome