- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221439
Cognitive Functional Therapy for Chronic Low Back Pain
September 7, 2020 updated by: Ney Armando Meziat Filho, Centro Universitário Augusto Motta
Cognitive Functional Therapy (CFT) Compared With a Combined Manual Therapy and Motor Control Exercise in Patients With Non-specific Chronic Low Back Pain: a Multicentre Randomized Controlled Trial
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.
It is important to replicate this study through a randomized clinical trial with similar objectives in another domain, but correcting 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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
One hundred and forty eight patients with chronic low back pain from two outpatient physiotherapy clinics in Brazil will be randomized to receive either Cognitive Functional Therapy or combined Manual Therapy and Motor Control Exercises.
Intervention: 4-10 sessions of CFT.
Control: 4-10 sessions of combined Manual Therapy and Motor Control Exercises.
Measurements: Clinical outcomes will be assessed at the baseline, 3 months, 6 months and 12 months after randomization.
Analysis: Intention-to-treat analysis will be performed, and linear mixed models will be calculated to evaluate the effect of the intervention.
Non-specific predictors, moderators and mediators of outcome will also be analysed.
Discussion: This study will investigate whether the results of the first CFT clinical trial can be replicated.
In addition, the results will contribute to a better understanding of the efficacy of the CFT approach.
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio de Janeiro, Brazil, 21.041-020
- Centro Universitário Augusto Motta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Low back pain for more than 3 months
- Disability score of 14% or more on the Oswestry Disability Index (ODI)
- Being able to walk independently with or without support
- Understand Portuguese well enough to be able to fill in the questionnaires
Exclusion Criteria:
- Main pain area is not the lumbar spine (from T12 to buttocks)
- Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
- Less than 6 months after lumbar spine, lower limb or abdomen surgery
- Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3 months
- Pregnancy
- Inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Scheuermann's disease)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Functional Therapy
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.
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There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
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Active Comparator: Manual Therapy and Exercise
The active comparator will be the combination of manual therapy and motor control exercises.
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According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with joint mobilization or manipulation techniques applied to the lower back or pelvis.
The active exercises will involve isolated contractions of the deep abdominal and multifidus muscles in different functional positions.
Most patients in this group will receive exercises to perform at home.
This will include general exercise or motor control exercise, but not related to CFT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 3 months after randomization
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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
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3 months after randomization
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Disability associated to low back pain
Time Frame: 3 months after randomization
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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 %.
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3 months after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global impression of recovery
Time Frame: 3, 6 and 12 months after randomization
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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).
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3, 6 and 12 months after randomization
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Pain intensity
Time Frame: 6 and 12 months after randomization
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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.
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6 and 12 months after randomization
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Disability associated to low back pain
Time Frame: 6 and 12 months after randomization
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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 %.
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6 and 12 months after randomization
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Patient Satisfaction
Time Frame: 3, 6 and 12 months after randomization
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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
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3, 6 and 12 months after randomization
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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It will be evaluated by the question "Do you feel anxious?"with the response options ranging from "Not at all" = 0 to "Quite anxious" = 10
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3 and 6 months after randomization
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Social isolation (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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It will be evaluated by the question"Do you feel socially isolated?"with the response options ranging from "Not at all isolated" = 0 to "Quite isolated" = 10
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3 and 6 months after randomization
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Catastrophization (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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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.
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3 and 6 months after randomization
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Depression (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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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.
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3 and 6 months after randomization
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Fear of movement (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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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).
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3 and 6 months after randomization
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Stress (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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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)
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3 and 6 months after randomization
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Sleep (mediator of outcome)
Time Frame: 3 and 6 months after randomization
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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
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3 and 6 months after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ney Meziat-Filho, PhD, Centro Universitario Augusto Motta, UNISUAM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Sveinsdottir V, Eriksen HR, Reme SE. Assessing the role of cognitive behavioral therapy in the management of chronic nonspecific back pain. J Pain Res. 2012;5:371-80. doi: 10.2147/JPR.S25330. Epub 2012 Oct 11.
- Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
January 12, 2020
Study Completion (Actual)
April 12, 2020
Study Registration Dates
First Submitted
July 16, 2017
First Submitted That Met QC Criteria
July 16, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CFT/MTEX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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