Cognitive Functional Therapy for Chronic Low Back Pain
- Conditions
- Low Back PainNeuromuscular ManifestationsBack PainPainSigns and Symptoms
- Interventions
- Other: Manual Therapy and Motor Control ExerciseBehavioral: Cognitive Functional Therapy
- Registration Number
- NCT03221439
- Lead Sponsor
- Centro Universitário Augusto Motta
- 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual Therapy and Exercise Manual Therapy and Motor Control Exercise The active comparator will be the combination of manual therapy and motor control exercises. Cognitive Functional Therapy Cognitive Functional Therapy 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.
- Primary Outcome Measures
Name Time Method Pain intensity 3 months after randomization It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days
Disability associated to low back pain 3 months after randomization It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
- Secondary Outcome Measures
Name Time Method Pain intensity 6 and 12 months after randomization It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END) 13. The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days.
Disability associated to low back pain 6 and 12 months after randomization It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
Patient Satisfaction 3, 6 and 12 months after randomization This is a simple questionnaire from 1 to 5 asking the patients how satisfied they were with their treatment: 1 = satisfied, 2 = just a little satisfied, 3 = neither satisfied nor dissatisfied, 4 = just a little dissatisfied, 5 = dissatisfied
Global impression of recovery 3, 6 and 12 months after randomization It will be evaluated based on the Global Perceived Effect Scale (GPES) which is an 11-point scale ranging from -5 ('vastly worse'), through 0 (no change) to +5 (completely recovered).
Trial Locations
- Locations (1)
Centro Universitário Augusto Motta
🇧🇷Rio de Janeiro, Brazil