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. As it is, it is important to carry out more studies involving CFT compared to other interventions already used in clinical practice and to correct 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
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 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 a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She 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 CORE-MT group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.
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
OTHERCore Training Exercise and Manual Therapy
According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with active exercises will involve contractions of abdominal and back muscles in different functional positions, as well as joint mobilization or manipulation techniques applied to the lower back or pélvis, when necessary. Most patients in this group will receive exercises to perform at home, but not related to CFT.
Sponsors
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 8 weeks, 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, 8 weeks, 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 a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She 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 CORE group will be treated by a physical therapist with clinical experience in manual therapy and core training 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 | 8 weeks | 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 | 8 weeks | 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 |
|---|---|---|
| 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 (mediator of outcome) | 8 weeks, 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 |
| Catastrophization (mediator of outcome) | 8 weeks, 6 and 12 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. |
| Global impression of recovery | 8 weeks, 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). |
| Fear of movement (mediator of outcome) | 8 weeks, 6 and 12 months 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) | 8 weeks, 6 and 12 months 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) |
| Sleep (mediator of outcome) | 8 weeks, 6 and 12 months 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 |
| Depression (mediator of outcome) | 8 weeks, 6 and 12 months 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. |
| 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. |
Countries
Brazil
Outcome results
None listed