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There is evidence, of a single randomized controlled trial, that CFT is better than combined manual therapy and motor control exercise for chronic low back pain. However, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. As it is, it is important to carry out more studies involving CFT compared to other interventions already used in clinical practice and to correct these methodological shortcomings. Therefore, the aim of the study is to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back pain.
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE-MT group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Functional Therapy (CFT) | Experimental | Cognitive Functional Therapy (CFT) is a behavioral intervention that addresses multiple aspects of low back pain. This approach focuses on changing the patient's beliefs, confronting their fears, educating them about pain mechanisms, increasing mental strength, and control of their body. This is done with functional tasks performed by individuals training them to reduce excessive muscle activity in the trunk and generate behavioral changes related to pain, from postures and provocative movements. |
|
| Core Training Exercise and Manual Therapy (CORE-MT) | Active Comparator | The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Functional Therapy | Behavioral | There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
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| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days | 8 weeks |
| Disability associated to low back pain | It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global impression of recovery | It will be evaluated based on the Global Perceived Effect Scale (GPES) which is an 11-point scale ranging from -5 ('vastly worse'), through 0 (no change) to +5 (completely recovered). | 8 weeks, 6 and 12 months after randomization |
| Pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto da Coluna | Campinas | São Paulo | 13084-759 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25920336 | Background | Meziat Filho N. Changing beliefs for changing movement and pain: Classification-based cognitive functional therapy (CB-CFT) for chronic non-specific low back pain. Man Ther. 2016 Feb;21:303-6. doi: 10.1016/j.math.2015.04.013. Epub 2015 Apr 16. | |
| 27052627 | Background | Meziat Filho N, Mendonca R, Nogueira LA. Lack of confidence in the lower limb: Cognitive Functional Therapy (CFT) for a unilateral loading impairment in chronic non-specific low back pain. Case report. Man Ther. 2016 Sep;25:104-8. doi: 10.1016/j.math.2016.02.007. Epub 2016 Mar 12. |
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Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.
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Clinical outcomes will be obtained in the evaluations carried out by a blinded assessor 8 weeks, 6 and 12 months after randomization. Both arms include active treatments, and participants will not know whether they are in the experimental group or control group.
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| Core Training Exercise and Manual Therapy | Other | According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with active exercises will involve contractions of abdominal and back muscles in different functional positions, as well as joint mobilization or manipulation techniques applied to the lower back or pélvis, when necessary. Most patients in this group will receive exercises to perform at home, but not related to CFT. |
|
It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END) 13. The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days. |
| 6 and 12 months after randomization |
| Disability associated to low back pain | It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %. | 6 and 12 months after randomization |
| Patient Satisfaction (mediator of outcome) | This is a simple questionnaire from 1 to 5 asking the patients how satisfied they were with their treatment: 1 = satisfied, 2 = just a little satisfied, 3 = neither satisfied nor dissatisfied, 4 = just a little dissatisfied, 5 = dissatisfied | 8 weeks, 6 and 12 months after randomization |
| Catastrophization (mediator of outcome) | It will be evaluated by the question "When I feel pain, it's terrible and I feel it's never going to get any better."with the response options ranging from "Never do that" = 0 to "Always do that" = 10. | 8 weeks, 6 and 12 months after randomization |
| Depression (mediator of outcome) | It will be evaluated by the question "During the past month have you often been bothered by feeling down, depressed or hopeless?" with the response options ranging from "Never" = 0 to "All the time" = 10. | 8 weeks, 6 and 12 months months after randomization |
| Fear of movement (mediator of outcome) | It will be assessed by the question "Physical activity might harm my back" and the response options will range from 0 ("completely disagree") to 10 ("completely agree). | 8 weeks, 6 and 12 months months after randomization |
| Stress (mediator of outcome) | It will be evaluated by the question "Do you feel stressed? and the response options will range from 0 ("completely disagree") to 10 ("completely agree) | 8 weeks, 6 and 12 months months after randomization |
| Sleep (mediator of outcome) | It will be evaluated by the question "Did you have sleep problems last month?" based on Subjective Health Complaints Inventory19. The response options will be "Not at all"=0, "A little"=1, "Some"=2, and "Serious"=3 | 8 weeks, 6 and 12 months months after randomization |
| 23208945 | Background | 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. |
| 26033941 | Background | 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. |
| 28704623 | Background | Caneiro JP, Smith A, Rabey M, Moseley GL, O'Sullivan P. Process of Change in Pain-Related Fear: Clinical Insights From a Single Case Report of Persistent Back Pain Managed With Cognitive Functional Therapy. J Orthop Sports Phys Ther. 2017 Sep;47(9):637-651. doi: 10.2519/jospt.2017.7371. Epub 2017 Jul 13. |
| 27013577 | Background | Bunzli S, McEvoy S, Dankaerts W, O'Sullivan P, O'Sullivan K. Patient Perspectives on Participation in Cognitive Functional Therapy for Chronic Low Back Pain. Phys Ther. 2016 Sep;96(9):1397-407. doi: 10.2522/ptj.20140570. Epub 2016 Mar 24. |
| 27745712 | Background | Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11. |
| 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. |
| 27002443 | Background | Goyal M, Haythornthwaite JA. Is It Time to Make Mind-Body Approaches Available for Chronic Low Back Pain? JAMA. 2016 Mar 22-29;315(12):1236-7. doi: 10.1001/jama.2016.2437. No abstract available. |
| 24480940 | Background | Menke JM. Do manual therapies help low back pain? A comparative effectiveness meta-analysis. Spine (Phila Pa 1976). 2014 Apr 1;39(7):E463-72. doi: 10.1097/BRS.0000000000000230. |
| 24281277 | Background | Kent P, Mirkhil S, Keating J, Buchbinder R, Manniche C, Albert HB. The concurrent validity of brief screening questions for anxiety, depression, social isolation, catastrophization, and fear of movement in people with low back pain. Clin J Pain. 2014 Jun;30(6):479-89. doi: 10.1097/AJP.0000000000000010. |
| 28042685 | Background | Paungmali A, Joseph LH, Sitilertpisan P, Pirunsan U, Uthaikhup S. Lumbopelvic Core Stabilization Exercise and Pain Modulation Among Individuals with Chronic Nonspecific Low Back Pain. Pain Pract. 2017 Nov;17(8):1008-1014. doi: 10.1111/papr.12552. Epub 2017 Feb 25. |
| 16034851 | Background | Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2. |
| 35384931 | Derived | Castro J, Correia L, Donato BS, Arruda B, Agulhari F, Pellegrini MJ, Belache FTC, de Souza CP, Fernandez J, Nogueira LAC, Reis FJJ, Ferreira AS, Meziat-Filho N. Cognitive functional therapy compared with core exercise and manual therapy in patients with chronic low back pain: randomised controlled trial. Pain. 2022 Dec 1;163(12):2430-2437. doi: 10.1097/j.pain.0000000000002644. Epub 2022 Apr 4. |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| D012816 | Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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