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| Name | Class |
|---|---|
| Curtin University | OTHER |
| KU Leuven | OTHER |
| Mayo General Hospital, Ireland | OTHER |
| Health Service Executive, Ireland |
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The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.
A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used. Patient with non- specific chronic low back pain will be assessed for eligibility. The patients fitting the inclusion criteria will be randomised to receive either the individual CFT or the group classes consisting of education and exercise. Participants' pain, disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general health, stress levels, as well as number and cost of treatments will be evaluated using a range of outcome measures at the start and on completion of the treatment. Patients will receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months after treatment to reassess clinical outcomes. If a participant does not respond to follow-up, they will be telephoned to ask if they wish to complete the questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual Cognitive Functional Therapy | Experimental | The intervention being tested has four main components: (1) a cognitive component, for each patient, their vicious cycle of pain will outlined in a diagram based on their findings from the examination and the Orebro Musculoskeletal Pain Screening Questionnaire; (2) specific movement exercises designed to normalize maladaptive movement behaviours; (3) targeted functional integration of activities in their daily life previously, reported to be avoided or provocative by the patient; and (4) a physical activity and lifestyle programme. |
|
| Group Exercise Classes | Active Comparator | 6 classes will take place in total. The class has 3 components each week. First, a 30 minute talk and discussion on chronic pain, and some tips for participants. Second, a 40 minute exercise circuit, involving aerobic exercise, and gentle stretching and strengthening exercises. Finally, a 5 minute relaxation/mindfulness session will take place at the end. The total time involved is approximately 1 hour and 15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Cognitive Functional Therapy | Behavioral | Cognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index (ODI) | Used to assess change in disability levels over the course of the trial and follow-up | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical rating scale (NRS) | Measures pain intensity | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Socio-economic Conditions Index | Measures socio-economic status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Kieran O' Sullivan, PhD | University of Limerick | Study Director |
| Mary O'Keeffe, BSc Physio | University of Limerick | Principal Investigator |
| Prof. Peter O'Sullivan, Professor | Curtin University | Principal Investigator |
| Dr Norelee Kennedy, PhD | University of Limerick | Principal Investigator |
| Prof. Wim Dankaerts, Professor | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ballina Primary Care Centre | Mayo | Connacht | 0000 | Ireland | ||
| Claremorris Primary Care Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21821612 | Background | O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012 Mar;46(4):224-7. doi: 10.1136/bjsm.2010.081638. Epub 2011 Aug 4. No abstract available. | |
| 23208945 | Result | Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain. 2013 Jul;17(6):916-28. doi: 10.1002/j.1532-2149.2012.00252.x. Epub 2012 Dec 4. |
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| OTHER |
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|
| Group Exercise Classes | Behavioral | Each class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body. |
|
| Baseline |
| Back Pain Beliefs Questionnaire | Assess a person's beliefs about their back pain | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ) | Assesses a person's level of fear-avoidance beliefs regarding physical activities. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| The catastrophising subscale of the Coping Strategies Questionnaire (CSQ) | Assesses level of pain catastrophizing. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Pain Self- Efficacy Questionnaire (PSEQ) | Assesses level of pain self-efficacy | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Subjective Health Complaints Inventory (SHC) | Assess level of subjective health complaints | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Nordic Musculoskeletal Screening Questionnaire | Assesses areas of bodily pain | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Stress subscale of the Depression, Anxiety and Stress scale (DASS 21) | Assesses patient's stress levels. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Patient Satisfaction Questionnaire | Assesses patient satisfaction | At 8-14 weeks |
| Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ) | Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity. | Measured at baseline |
| Medication usage | To assess changes in levels of medication used. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months |
| Economic evaluation | Assesses direct and indirect costs of both treatment arms to see which is more cost-effective. | 6, 12 and 36 months |
| Level of co-interventions | Assesses the number/type of healthcare services availed of throughout the intervention period. | Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months |
| Mayo |
| Connacht |
| 0000 |
| Ireland |
| Mayo General Hospital | Mayo | Connacht | 0000 | Ireland |
| 31630089 | Derived | O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19. |
| 26033941 | Derived | O'Keeffe M, Purtill H, Kennedy N, O'Sullivan P, 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. BMJ Open. 2015 Jun 1;5(6):e007156. doi: 10.1136/bmjopen-2014-007156. |