title: TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain-study rationale and protocol.
abstract: Low back pain (LBP) is the health condition that carries the greatest disability burden worldwide; however, there is only modest support for interventions to prevent LBP. The aim of this trial is to establish the effectiveness and cost-effectiveness of group-based exercise and educational classes compared with a minimal intervention control in preventing recurrence of LBP in people who have recently recovered from an episode of LBP.
  
  
  
  TOPS will be a pragmatic comparative effectiveness randomised clinical trial with a parallel economic evaluation combining three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence) with the same methodology. 1482 participants who have recently recovered from LBP will be randomised to either a comprehensive exercise and education programme or a minimal intervention control. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of LBP. Effectiveness will be assessed using survival analysis. Cost-effectiveness will be assessed from the societal perspective.
  
  
  
  This trial has been approved by the University of Sydney Human Research Ethics Committee (HREC) (ref: 2015/728) and prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: 12615000939594). We will also obtain ethics approval from the Australian Defence Force HREC. The results of this study will be submitted for publication in a prominent journal and widely publicised in the general media.
  
  
  
  Australian and New Zealand Clinical Trial Registry (ANZCTR) 12615000939594.
authors.affiliation: Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Matthew L
authors.identifier: 0000-0002-2621-4811
authors.initials: ML
authors.lastname: Stevens
authors.affiliation: Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Chung-Wei C
authors.initials: CW
authors.lastname: Lin
authors.affiliation: Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Hancock
authors.affiliation: Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Latimer
authors.affiliation: Monash Department of Clinical Epidemiology, Cabrini Institute, Melbourne, Victoria, Australia.
authors.forename: Rachelle
authors.initials: R
authors.lastname: Buchbinder
authors.affiliation: Oslo and Akershus University College of Applied Sciences, Oslo/FORMI, Oslo University Hospital Norway, Oslo, Norway.
authors.forename: Margreth
authors.initials: M
authors.lastname: Grotle
authors.affiliation: Department of Health Sciences, Faculty of Earth & Life Sciences, VU University, Amsterdam, The Netherlands.
authors.forename: Maurits
authors.initials: M
authors.lastname: van Tulder
authors.affiliation: Nepean Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Charles H
authors.initials: CH
authors.lastname: New
authors.affiliation: Bounce Back Active Rehabilitation Systems, Sydney, Australia.
authors.forename: Trish
authors.initials: T
authors.lastname: Wisby-Roth
authors.affiliation: Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Chris G
authors.initials: CG
authors.lastname: Maher
mesh_terms: D000328:Adult; D000368:Aged; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010353:Patient Education as Topic; D018401:Sample Size
keywords: education; exercise; prevention; randomised clinical trial