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Cognitive Functional Therapy for Chronic Low Back Pain

NCT03221439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2020-09-09

No results posted yet for this study

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. It is important to replicate this study through a randomized clinical trial with similar objectives in another domain, but correcting 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.

Conditions

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

Interventions

BEHAVIORAL

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

OTHER

Manual Therapy and Motor Control Exercise

According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with joint mobilization or manipulation techniques applied to the lower back or pelvis. The active exercises will involve isolated contractions of the deep abdominal and multifidus muscles in different functional positions. Most patients in this group will receive exercises to perform at home. This will include general exercise or motor control exercise, but not related to CFT.

Sponsors & Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV

  • Centro Universitário Augusto Motta

    lead OTHER

Principal Investigators

  • Ney Meziat-Filho, PhD · Centro Universitário Augusto Motta, UNISUAM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-01-12
Completion
2020-04-12

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221439 on ClinicalTrials.gov