TY - JOUR AU - Latimer J. AU - van Tulder M. AU - Grotle M. AU - Hancock M. AU - Buchbinder R. AU - Stevens M. AU - Lin C. AU - New C. AU - Wisby-Roth T. AU - Maher C. AB -

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trial Registry (ANZCTR) 12615000939594.

AD - Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.
Monash Department of Clinical Epidemiology, Cabrini Institute, Melbourne, Victoria, Australia.
Oslo and Akershus University College of Applied Sciences, Oslo/FORMI, Oslo University Hospital Norway, Oslo, Norway.
Department of Health Sciences, Faculty of Earth & Life Sciences, VU University, Amsterdam, The Netherlands.
Nepean Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
Bounce Back Active Rehabilitation Systems, Sydney, Australia. AN - 27217287 BT - BMJ Open DP - NLM ET - 2016/05/25 LA - eng LB - AUS
MSK
FY16 M1 - 5 N1 - Stevens, Matthew L
Lin, Chung-Wei C
Hancock, Mark J
Latimer, Jane
Buchbinder, Rachelle
Grotle, Margreth
van Tulder, Maurits
New, Charles H
Wisby-Roth, Trish
Maher, Chris G
England
BMJ Open. 2016 May 23;6(5):e011492. doi: 10.1136/bmjopen-2016-011492. N2 -

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trial Registry (ANZCTR) 12615000939594.

PY - 2016 SN - 2044-6055 (Electronic) EP - e011492 T2 - BMJ Open TI - TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain-study rationale and protocol VL - 6 Y2 - FY16 ER -