title: 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.
abstract: BACKGROUND
  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
  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 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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  (ClinicalTrials.gov NCT02145728).
authors.affiliation: Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.
authors.forename: Mary
authors.initials: M
authors.lastname: O'Keeffe
authors.affiliation: Department of Mathematics and Statistics, University of Limerick, Limerick, Munster, Ireland.
authors.forename: Helen
authors.initials: H
authors.lastname: Purtill
authors.affiliation: Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.
authors.forename: Norelee
authors.initials: N
authors.lastname: Kennedy
authors.affiliation: School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: O'Sullivan
authors.affiliation: Musculoskeletal Research Unit, Department of Rehabilitation Sciences and Physiotherapy, University of Leuven, Leuven, Belgium.
authors.forename: Wim
authors.initials: W
authors.lastname: Dankaerts
authors.affiliation: Ballina Primary Care Centre, Ballina, Mayo, Ireland.
authors.forename: Aidan
authors.initials: A
authors.lastname: Tighe
authors.affiliation: Physiotherapy Department, Mayo General Hospital, Castlebar, Mayo, Ireland.
authors.forename: Lars
authors.initials: L
authors.lastname: Allworthy
authors.affiliation: Claremorris Primary Care Centre, Claremorris, Mayo, Ireland.
authors.forename: Louise
authors.initials: L
authors.lastname: Dolan
authors.affiliation: Department of Mathematics and Statistics, University of Limerick, Limerick, Munster, Ireland.
authors.forename: Norma
authors.initials: N
authors.lastname: Bargary
authors.affiliation: Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.
authors.forename: Kieran
authors.initials: K
authors.lastname: O'Sullivan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D015444:Exercise / Q000502:physiology*; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D010353:Patient Education as Topic / Q000379:methods*; D012107:Research Design; D055815:Young Adult
keywords: PAIN MANAGEMENT; PRIMARY CARE; PUBLIC HEALTH