title: Evaluating rehabilitation following lumbar fusion surgery (REFS): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The rate of lumbar fusion surgery (LFS) is increasing. Clinical recovery often lags technical outcome. Approximately 40% of patients undergoing LFS rate themselves as symptomatically unchanged or worse following surgery. There is little research describing rehabilitation following LFS with no clear consensus as to what constitutes the optimum strategy. It is important to develop appropriate rehabilitation strategies to help patients manage pain and recover lost function following LFS.
  
  
  METHODS
  The study design is a randomised controlled feasibility trial exploring the feasibility of providing a complex multi-method rehabilitation intervention 3 months following LFS. The rehabilitation protocol that we have developed involves small participant groups of therapist led structured education utilising principles of cognitive behavioral therapy (CBT), progressive, individualised exercise and peer support. Participants will be randomly allocated to either usual care (UC) or the rehabilitation group (RG). We will recruit 50 subjects, planning to undergo LFS, over 30 months. Following LFS all participants will experience normal care for the first 3 months. Subsequent to a satisfactory 3 month surgical review they will commence their allocated post-operative treatment (RG or UC). Data collection will occur at baseline (pre-operatively), 3, 6 and 12 months post-operatively. Primary outcomes will include an assessment of feasibility factors (including recruitment and compliance). Secondary outcomes will evaluate the acceptability and characteristics of a limited cluster of quantitative measures including the Oswestry Disability Index (ODI) and an aggregated assessment of physical function (walking 50 yards, ascend/descend a flight of stairs). A nested qualitative study will evaluate participants' experiences.
  
  
  CONCLUSIONS
  This study will evaluate the feasibility of providing complex, structured rehabilitation in small groups 3 months following technically successful LFS. We will identify strengths and weakness of the proposed protocol and the usefulness and characteristics of the planned outcome measures. This will help shape the development of rehabilitation strategies and inform future work aimed at evaluating clinical efficacy.
  
  
  BACKGROUND
  ISRCTN60891364, 10/07/2014.
authors.affiliation: Internal Box 8, Victor Horsely Department of Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, WC1 3BG, UK. james.greenwood@UCLH.NHS.UK.
authors.forename: James
authors.initials: J
authors.lastname: Greenwood
authors.affiliation: Biodynamics Lab, Imperial College London, Charing Cross Hospital, Charing Cross Campus, London, W6 8RP, UK. a.mcgregor@imperial.ac.uk.
authors.forename: Alison
authors.initials: A
authors.lastname: McGregor
authors.affiliation: St Georges University of London, Faculty of Health and Social Care Sciences, 2nd Floor Grosvenor Wing, Cranmer Terrace, London, SW17 0RE, UK. F.Jones@sgul.kingston.ac.uk.
authors.forename: Fiona
authors.initials: F
authors.lastname: Jones
authors.affiliation: St Georges University of London, Faculty of Health and Social Care Sciences, 2nd Floor Grosvenor Wing, Cranmer Terrace, London, SW17 0RE, UK. Michael.hurley@sgul.kingston.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Hurley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001696:Biomechanical Phenomena; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D005081:Exercise Therapy; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008131:London; D008159:Lumbar Vertebrae / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D010379:Peer Group; D020127:Recovery of Function; D012107:Research Design; D013123:Spinal Fusion / Q000009:adverse effects / Q000534:rehabilitation*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult