Low Back Pain, Back Pain, Pain, Signs and Symptoms, Neuromuscular Manifestations
Conditions
Keywords
back pain, physiotherapy, exercise therapy, cognitive functional therapy, low back pain, backache, lower back pain, lumbago, multidimensional, biopsychosocial
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.
Interventions
BEHAVIORALCognitive 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
OTHERManual 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
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Centro Universitário Augusto Motta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Clinical outcomes will be obtained in the evaluations carried out by a blinded assessor 3, 6 and 12 months after randomization. Both arms include active treatments, and participants will not know whether they are in the experimental group or control group.
Intervention model description
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, immediately after the end of the intervention (12 weeks), as in 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 two physical therapists that attended twice the CFT workshops with two of the tutors of the method. They 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 MT-EX group will be treated by two physical therapists with more than 8 years of clinical experience in manual therapy and motor control exercises.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety (mediator of outcome) | 3 and 6 months after randomization | It will be evaluated by the question Do you feel anxious?with the response options ranging from Not at all = 0 to Quite anxious = 10 |
| Sleep (mediator of outcome) | 3 and 6 months after randomization | It will be evaluated by the question Did you have sleep problems last month? based on Subjective Health Complaints Inventory19. The response options will be Not at all=0, A little=1, Some=2, and Serious=3 |
| Social isolation (mediator of outcome) | 3 and 6 months after randomization | It will be evaluated by the questionDo you feel socially isolated?with the response options ranging from Not at all isolated = 0 to Quite isolated = 10 |
| Catastrophization (mediator of outcome) | 3 and 6 months after randomization | It will be evaluated by the question When I feel pain, it's terrible and I feel it's never going to get any better.with the response options ranging from Never do that = 0 to Always do that = 10. |
| Depression (mediator of outcome) | 3 and 6 months after randomization | It will be evaluated by the question During the past month have you often been bothered by feeling down, depressed or hopeless? with the response options ranging from Never = 0 to All the time = 10. |
| Fear of movement (mediator of outcome) | 3 and 6 months after randomization | It will be assessed by the question Physical activity might harm my back and the response options will range from 0 (completely disagree) to 10 (completely agree). |
| Stress (mediator of outcome) | 3 and 6 months after randomization | It will be evaluated by the question Do you feel stressed? and the response options will range from 0 (completely disagree) to 10 (completely agree) |
Countries
Brazil
Outcome results
None listed