CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
Cognitive Functional Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03221439
NCT03221439N/ACompleted

Cognitive Functional Therapy (CFT) Compared With a Combined Manual Therapy and Motor Control Exercise in Patients With Non-specific Chronic Low Back Pain: a Multicentre Randomized Controlled Trial

Centro Universitário Augusto Motta·interventional·Posted Jul 18, 2017·Updated Sep 9, 2020

In Brief

A clinical study evaluating Cognitive Functional Therapy and Manual Therapy and Motor Control Exercise for Low Back Pain and 4 related conditions. Completed, enrolled 148 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 18, 2017
Enrollment StartAug 1, 2017
Primary CompletionJan 12, 2020
Study CompletionApr 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.0 years ago

Interventions

Cognitive Functional Therapybehavioral

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

Manual Therapy and Motor Control Exerciseother

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.