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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.
BMJ Open. 2015 Jun 01; 5(6):e007156.BO

Abstract

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 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 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

(ClinicalTrials.gov NCT02145728).

Authors+Show Affiliations

Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.Department of Mathematics and Statistics, University of Limerick, Limerick, Munster, Ireland.Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia.Musculoskeletal Research Unit, Department of Rehabilitation Sciences and Physiotherapy, University of Leuven, Leuven, Belgium.Ballina Primary Care Centre, Ballina, Mayo, Ireland.Physiotherapy Department, Mayo General Hospital, Castlebar, Mayo, Ireland.Claremorris Primary Care Centre, Claremorris, Mayo, Ireland.Department of Mathematics and Statistics, University of Limerick, Limerick, Munster, Ireland.Department of Clinical Therapies, University of Limerick, Limerick, Munster, Ireland.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26033941

Citation

O'Keeffe, Mary, et al. "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." BMJ Open, vol. 5, no. 6, 2015, pp. e007156.
O'Keeffe M, Purtill H, Kennedy N, et al. 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. BMJ Open. 2015;5(6):e007156.
O'Keeffe, M., Purtill, H., Kennedy, N., O'Sullivan, P., Dankaerts, W., Tighe, A., Allworthy, L., Dolan, L., Bargary, N., & O'Sullivan, K. (2015). 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. BMJ Open, 5(6), e007156. https://doi.org/10.1136/bmjopen-2014-007156
O'Keeffe M, et al. 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. BMJ Open. 2015 Jun 1;5(6):e007156. PubMed PMID: 26033941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - O'Keeffe,Mary, AU - Purtill,Helen, AU - Kennedy,Norelee, AU - O'Sullivan,Peter, AU - Dankaerts,Wim, AU - Tighe,Aidan, AU - Allworthy,Lars, AU - Dolan,Louise, AU - Bargary,Norma, AU - O'Sullivan,Kieran, Y1 - 2015/06/01/ PY - 2015/6/3/entrez PY - 2015/6/3/pubmed PY - 2016/3/11/medline KW - PAIN MANAGEMENT KW - PRIMARY CARE KW - PUBLIC HEALTH SP - e007156 EP - e007156 JF - BMJ open JO - BMJ Open VL - 5 IS - 6 N2 - 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 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 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: (ClinicalTrials.gov NCT02145728). SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/26033941/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_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=26033941 DB - PRIME DP - Unbound Medicine ER -