title: Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery.
abstract: BACKGROUND
  The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery.
  
  
  METHODS
  The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers.
  
  
  CONCLUSIONS
  It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN42281022.
authors.affiliation: Department of Physical and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark. nannrasm@rm.dk.
authors.forename: Nanna
authors.initials: N
authors.lastname: Rolving
authors.forename: Lisa Gregersen
authors.initials: LG
authors.lastname: Oestergaard
authors.forename: Morten Vejs
authors.initials: MV
authors.lastname: Willert
authors.forename: Finn Bjarke
authors.initials: FB
authors.lastname: Christensen
authors.forename: Frank
authors.initials: F
authors.lastname: Blumensaat
authors.forename: Cody
authors.initials: C
authors.lastname: Bünger
authors.forename: Claus Vinther
authors.initials: CV
authors.lastname: Nielsen
mesh_terms: D000041:Absenteeism; D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000150:complications / Q000601:surgery*; D017116:Low Back Pain / Q000209:etiology / Q000517:prevention & control / Q000523:psychology; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D010149:Postoperative Pain / Q000517:prevention & control / Q000523:psychology; D010348:Patient Care Team; D011788:Quality of Life; D012107:Research Design; D057566:Self Report; D013123:Spinal Fusion / Q000534:rehabilitation*; D013168:Spondylolisthesis / Q000150:complications / Q000601:surgery*; D055815:Young Adult