• Mary O'Keeffe, Helen Purtill, Norelee Kennedy, Peter O'Sullivan, Wim Dankaerts, Aidan Tighe, Lars Allworthy, Louise Dolan, Norma Bargary, and Kieran O'Sullivan.
• Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.
• BMJ Open. 2015 Jan 1; 5 (6): e007156.

IntroductionNon-specific chronic low back pain (NSCLBP) is a very common and costly musculoskeletal disorder associated with a complex interplay of biopsychosocial factors. Cognitive functional therapy (CFT) represents a novel, patient-centred intervention which directly challenges pain-related behaviours in a cognitively integrated, functionally specific and graduated manner. CFT aims to target all biopsychosocial factors that are deemed to be barriers to recovery for an individual patient with NSCLBP. A recent randomised controlled trial (RCT) demonstrated the superiority of individualised CFT for NSCLBP compared to manual therapy combined with exercise. However, several previous RCTs have suggested that class-based interventions are as effective as individualised interventions. Therefore, it is important to examine whether an individualised intervention, such as CFT, demonstrates clinical effectiveness compared to a relatively cheaper exercise and education class. The current study will compare the clinical effectiveness of individualised CFT with a combined exercise and pain education class in people with NSCLBP.Methods And AnalysisThis study is a multicentre RCT. 214 participants, aged 18-75 years, with NSCLBP for at least 6 months will be randomised to one of two interventions across three sites. The experimental group will receive individualised CFT and the length of the intervention will be varied in a pragmatic manner based on the clinical progression of participants. The control group will attend six classes which will be provided over a period of 6-8 weeks. Participants will be assessed preintervention, postintervention and after 6 and 12 months. The primary outcomes will be functional disability and pain intensity. Non-specific predictors, moderators and mediators of outcome will also be analysed.Ethics And DisseminationEthical approval has been obtained from the Mayo General Hospital Research Ethics Committee (MGH-14-UL). Outcomes will be disseminated through publication according to the SPIRIT statement and will be presented at scientific conferences.Trial Registration Number(ClinicalTrials.gov NCT02145728).Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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