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

Centro Universitário Augusto Motta

Status: Completed

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

Treatments: Behavioral: Cognitive Functional Therapy; Other: Core Training Exercise and Manual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03273114

neymeziat

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

Cognitive Functional Therapy (CFT)

Experimental group

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.

Treatment:

Behavioral: Cognitive Functional Therapy

Core Training Exercise and Manual Therapy (CORE-MT)

Active Comparator group

Description:

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

Treatment:

Other: Core Training Exercise and Manual Therapy