Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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-MT group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.

Official Title
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Cognitive Functional Therapy (CFT) Compared With a Combined Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Non-specific Chronic Low Back Pain: a Randomized Controlled Trial

Conditions
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Low Back Pain, Back Pain, Pain, Signs and Symptoms, Neuromuscular Manifestations

Intervention / Treatment
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* Behavioral: Cognitive Functional Therapy
* Other: Core Training Exercise and Manual Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Functional Therapy (CFT)<br>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. | Behavioral: Cognitive Functional Therapy<br>* 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<br>|
| Active Comparator: Core Training Exercise and Manual Therapy (CORE-MT)<br>The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT). | Other: Core Training Exercise and Manual Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back pain, physiotherapy, exercise therapy, cognitive functional therapy, low back pain, backache, lower back pain, lumbago, multidimensional, biopsychosocial