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

Not Applicable

Completed

• Conditions: Pain; Low Back Pain; Neuromuscular Manifestations; Back Pain; Signs and Symptoms
• Interventions: Behavioral: Cognitive Functional Therapy; Other: Core Training Exercise and Manual Therapy

• Registration Number: NCT03273114
• Lead Sponsor: Centro Universitário Augusto Motta

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. 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

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.

Study Timeline

• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-01
• Study Start: 2017-09-06
• Study First Posted: 2017-09-06
• Primary Completion: 2020-06-28
• Study Completion: 2020-06-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Functional Therapy (CFT)	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.
Core Training Exercise and Manual Therapy (CORE-MT)	Core Training Exercise and Manual Therapy	The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT).

Primary Outcome Measures

Name	Time	Method
Pain intensity	8 weeks	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	8 weeks	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

Name	Time	Method
Global impression of recovery	8 weeks, 6 and 12 months after randomization	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	6 and 12 months after randomization	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	6 and 12 months after randomization	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 (mediator of outcome)	8 weeks, 6 and 12 months after randomization	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
Catastrophization (mediator of outcome)	8 weeks, 6 and 12 months after randomization	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.
Depression (mediator of outcome)	8 weeks, 6 and 12 months months after randomization	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.
Fear of movement (mediator of outcome)	8 weeks, 6 and 12 months months after randomization	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).
Stress (mediator of outcome)	8 weeks, 6 and 12 months months after randomization	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)
Sleep (mediator of outcome)	8 weeks, 6 and 12 months months after randomization	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

Trial Locations

Locations (1)

Instituto da Coluna; 🇧🇷 Campinas, São Paulo, Brazil