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
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, patientcentred intervention which directly challenges painrelated beha...
| Main Authors: | , , , , , , , , , |
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| Format: | Journal Article |
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BMJ Publishing Group
2015
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| Online Access: | http://hdl.handle.net/20.500.11937/44372 |
| _version_ | 1848756982086893568 |
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| author | O'Keeffe, M. Purtill, H. Kennedy, N. O'Sullivan, Peter Dankaerts, W. Tighe, A. Allworthy, L. Dolan, L. Bargary, N. O'Sullivan, K. |
| author_facet | O'Keeffe, M. Purtill, H. Kennedy, N. O'Sullivan, Peter Dankaerts, W. Tighe, A. Allworthy, L. Dolan, L. Bargary, N. O'Sullivan, K. |
| author_sort | O'Keeffe, M. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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, patientcentred intervention which directly challenges painrelated 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. |
| first_indexed | 2025-11-14T09:20:51Z |
| format | Journal Article |
| id | curtin-20.500.11937-44372 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T09:20:51Z |
| publishDate | 2015 |
| publisher | BMJ Publishing Group |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-443722017-09-13T14:12:17Z 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 O'Keeffe, M. Purtill, H. Kennedy, N. O'Sullivan, Peter Dankaerts, W. Tighe, A. Allworthy, L. Dolan, L. Bargary, N. O'Sullivan, K. 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, patientcentred intervention which directly challenges painrelated 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. 2015 Journal Article http://hdl.handle.net/20.500.11937/44372 10.1136/bmjopen-2014-007156 BMJ Publishing Group fulltext |
| spellingShingle | O'Keeffe, M. Purtill, H. Kennedy, N. O'Sullivan, Peter Dankaerts, W. Tighe, A. Allworthy, L. Dolan, L. Bargary, N. O'Sullivan, K. 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://hdl.handle.net/20.500.11937/44372 |