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

NCT ID: NCT03273114

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2020-06-28

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.

Conditions

Low Back Pain; Back Pain; Pain; Signs and Symptoms; Neuromuscular Manifestations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Functional Therapy (CFT)

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.

Group Type: EXPERIMENTAL

Cognitive Functional Therapy

Intervention Type: BEHAVIORAL

There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):

1. 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.

2. Specific Functional training is designed to normalize maladaptive or provocative movement and posture.

3. 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)

4. Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies

Core Training Exercise and Manual Therapy (CORE-MT)

The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT).

Group Type: ACTIVE_COMPARATOR

Core Training Exercise and Manual Therapy

Intervention Type: 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.

Interventions

Cognitive Functional Therapy

There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):

1. 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.

2. Specific Functional training is designed to normalize maladaptive or provocative movement and posture.

3. 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)

4. Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies

Intervention Type: BEHAVIORAL

Core Training Exercise and Manual Therapy

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Universitário Augusto Motta

OTHER

Sponsor Role: lead

Responsible Party

Ney Armando Meziat Filho

Assistant Professor, Rehabilitation Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto da Coluna

Campinas, São Paulo, Brazil

Countries

Brazil

References

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Reference Type: DERIVED

PMID: 35384931 (View on PubMed)

Other Identifiers

neymeziat

Identifier Type: -

Identifier Source: org_study_id