Clinical trial NCT03273114: Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
measure: Disability associated to low back pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Global impression of recovery
timeFrame: 8 weeks, 6 and 12 months after randomization
measure: Pain intensity
timeFrame: 6 and 12 months after randomization
measure: Disability associated to low back pain
timeFrame: 6 and 12 months after randomization
measure: Patient Satisfaction (mediator of outcome)
timeFrame: 8 weeks, 6 and 12 months after randomization
measure: Catastrophization (mediator of outcome)
timeFrame: 8 weeks, 6 and 12 months after randomization
measure: Depression (mediator of outcome)
timeFrame: 8 weeks, 6 and 12 months months after randomization
measure: Fear of movement (mediator of outcome)
timeFrame: 8 weeks, 6 and 12 months months after randomization
measure: Stress (mediator of outcome)
timeFrame: 8 weeks, 6 and 12 months months after randomization
measure: Sleep (mediator of outcome)
timeFrame: 8 weeks, 6 and 12 months months after randomization
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Instituto da Coluna
state: São Paulo
Study officials:
References:
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