Back to resultsCognitive Functional Therapy for Chronic Low Back Pain
Primary Purpose
Low Back Pain, Back Pain, Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cognitive Functional Therapy
Manual Therapy and Motor Control Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring back pain, physiotherapy, exercise therapy, cognitive functional therapy, low back pain, backache, lower back pain, lumbago, multidimensional, biopsychosocial
Eligibility Criteria
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)
Sites / Locations
- Centro Universitário Augusto Motta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Functional Therapy
Manual Therapy and Exercise
Arm Description
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.
The active comparator will be the combination of manual therapy and motor control exercises.
Outcomes
Primary Outcome Measures
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
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 %.
Secondary Outcome Measures
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).
Pain intensity
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.
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 %.
Patient Satisfaction
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
Full Information
NCT ID
NCT03221439
First Posted
July 16, 2017
Last Updated
September 7, 2020
Sponsor
Centro Universitário Augusto Motta
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
1. Study Identification
Unique Protocol Identification Number
NCT03221439
Brief Title
Cognitive Functional Therapy for Chronic Low Back Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
April 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário Augusto Motta
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Back Pain, Pain, Signs and Symptoms, Neuromuscular Manifestations
Keywords
back pain, physiotherapy, exercise therapy, cognitive functional therapy, low back pain, backache, lower back pain, lumbago, multidimensional, biopsychosocial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, immediately after the end of the intervention (12 weeks), as in 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 two physical therapists that attended twice the CFT workshops with two of the tutors of the method. They 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 MT-EX group will be treated by two physical therapists with more than 8 years of clinical experience in manual therapy and motor control exercises.
Masking
ParticipantOutcomes Assessor
Masking Description
Clinical outcomes will be obtained in the evaluations carried out by a blinded assessor 3, 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.
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Functional Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual Therapy and Exercise
Arm Type
Active Comparator
Arm Description
The active comparator will be the combination of manual therapy and motor control exercises.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Functional Therapy
Intervention Description
There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability.
Specific Functional training is designed to normalize maladaptive or provocative movement and posture.
Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting)
Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Motor Control Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
3 months after randomization
Title
Disability associated to low back pain
Description
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 %.
Time Frame
3 months after randomization
Secondary Outcome Measure Information:
Title
Global impression of recovery
Description
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).
Time Frame
3, 6 and 12 months after randomization
Title
Pain intensity
Description
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.
Time Frame
6 and 12 months after randomization
Title
Disability associated to low back pain
Description
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 %.
Time Frame
6 and 12 months after randomization
Title
Patient Satisfaction
Description
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
Time Frame
3, 6 and 12 months after randomization
Other Pre-specified Outcome Measures:
Title
Anxiety (mediator of outcome)
Description
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
Time Frame
3 and 6 months after randomization
Title
Social isolation (mediator of outcome)
Description
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
Time Frame
3 and 6 months after randomization
Title
Catastrophization (mediator of outcome)
Description
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.
Time Frame
3 and 6 months after randomization
Title
Depression (mediator of outcome)
Description
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.
Time Frame
3 and 6 months after randomization
Title
Fear of movement (mediator of outcome)
Description
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).
Time Frame
3 and 6 months after randomization
Title
Stress (mediator of outcome)
Description
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)
Time Frame
3 and 6 months after randomization
Title
Sleep (mediator of outcome)
Description
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
Time Frame
3 and 6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ney Meziat-Filho, PhD
Organizational Affiliation
Centro Universitário Augusto Motta, UNISUAM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário Augusto Motta
City
Rio de Janeiro
ZIP/Postal Code
21.041-020
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27745712
Citation
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.
Results Reference
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21821612
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
24480940
Citation
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.
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PubMed Identifier
23091394
Citation
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.
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PubMed Identifier
26742533
Citation
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.
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PubMed Identifier
26033941
Citation
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.
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PubMed Identifier
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Citation
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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Citation
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.
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Citation
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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Cognitive Functional Therapy for Chronic Low Back Pain
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