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Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial
  1. Mary O'Keeffe1,
  2. Helen Purtill2,
  3. Norelee Kennedy1,
  4. Peter O'Sullivan3,
  5. Wim Dankaerts4,
  6. Aidan Tighe5,
  7. Lars Allworthy6,
  8. Louise Dolan7,
  9. Norma Bargary2,
  10. Kieran O'Sullivan1
  1. 1Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland
  2. 2Department of Mathematics and Statistics, University of Limerick, Limerick, Munster, Ireland
  3. 3School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia
  4. 4Musculoskeletal Research Unit, Department of Rehabilitation Sciences and Physiotherapy, University of Leuven, Leuven, Belgium
  5. 5Ballina Primary Care Centre, Ballina, Mayo, Ireland
  6. 6Physiotherapy Department, Mayo General Hospital, Castlebar, Mayo, Ireland
  7. 7Claremorris Primary Care Centre, Claremorris, Mayo, Ireland
  1. Correspondence to Mary O'Keeffe; Mary.OKeeffe{at}


Introduction Non-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 analysis This 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 and12 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 dissemination Ethical 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 ( NCT02145728).


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