NCT03221439

Cognitive Functional Therapy for Chronic Low Back Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Centro Universitário Augusto Motta · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One hundred and forty eight patients with chronic low back pain from two outpatient physiotherapy clinics in Brazil will be randomized to receive either Cognitive Functional Therapy or combined Manual Therapy and Motor Control Exercises. Intervention: 4-10 sessions of CFT. Control: 4-10 sessions of combined Manual Therapy and Motor Control Exercises. Measurements: Clinical outcomes will be assessed at the baseline, 3 months, 6 months and 12 months after randomization. Analysis: Intention-to-treat analysis will be performed, and linear mixed models will be calculated to evaluate the effect of the intervention. Non-specific predictors, moderators and mediators of outcome will also be analysed. Discussion: This study will investigate whether the results of the first CFT clinical trial can be replicated. In addition, the results will contribute to a better understanding of the efficacy of the CFT approach.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-01-12
• Completion: 2020-04-12
• First posted: 2017-07-18
• Last updated: 2020-09-09

Locations

1 site across 1 country: Brazil