Chronic Low Back Pain
Conditions
Brief summary
Non-specific low back pain is a common condition. Exercise is effective treatment for chronic low back pain. We hypothesized the functional exercise group will present pain reduction and functional improvement. The purpose of this study is investigated the effectiveness of an functional exercise program for people with nonspecific chronic low back pain. Patients will be randomly divided into 2 groups: control group (minimal intervention - mini back school and analgesic) and group will receive a functional exercise protocol associated with minimal intervention.
Interventions
OTHERFunctional Exercise Protocol
Functional exercise protocol. This protocol started with corporal conscience exercise, breathing, abdominal activation, activities such as sitting, getting up, climbing stairs, reaching with arms, moving forward, bodyweight exercises, bridges and boards. This protocol will be performed during 12 weeks, two sessions per week.
OTHERMinimal
Analgesic use when necessary and a single back scholl class
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 50 years * Low back pain for more than 3 months * Low back pain with numeric pain scale between 3 - 8 cm * Understand Portuguese well enough to be able to fill in the questionnaires
Exclusion criteria
* Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture; * 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 * Previous spinal surgery; * Previous spinal infiltration for pain relief in the last 3 months; * Several scoliosis; * Litigation; * Pregnancy; * Fibromyalgia; * People who had changed physical activity or undergone physical therapy in the previous 3 months; * Presence of any contraindication to exercise; * Planned travel in the next 12 weeks; * Geographic inaccessibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low back of pain intensity measured with Numeric Pain Rating Scale | Baseline, 6, 12 and 24 weeks | It will be measured by the Brazilian version of the Numeric Pain Rating Scale (NPRS) 11 points. The NPRS 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. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability associated to low back pain measured with Roland Morris Disability | Baseline, 6, 12 and 24 weeks | Change in Roland Morris Disability score |
| Fear of movement measured with Fear-Avoidance Beliefs Questionnaire | Baseline, 6, 12 and 24 weeks | Change in Fear-Avoidance Beliefs Questionnaire score |
| Quality of life measured with Short form-36 questionnaire | Baseline, 6, 12 and 24 weeks | Change in Short form-36 questionnaire score |
| Disability associated to low back pain measured with Oswestry Disability Index | Baseline, 6, 12 and 24 weeks | Change in Oswestry Disability Index score |
| Function measured with the timed to up and go test | Baseline, 6, 12 and 24 weeks | Change in timed to up and go test |
| Patient's global impression of recovery measured with a likert scale | 6, 12 and 24 weeks after baseline | It will be evaluated based on the global perceived effect by the Likert Scale Score. The Likert scale, used to evaluate the patient's global perceived effect with treatment. The patients answered the question 'After starting the treatment, how do you think your low back is?' with one of the following statements: much worse, a little worse, unchanged, a little better, much better. |
| Analgesic consumption | 6, 12 and 24 weeks after baseline | Change in analgesic consumption |
| Function measured with the 6-minute walk test | Baseline, 6, 12 and 24 weeks | Change in 6-minute walk test |
Countries
Brazil
Contacts
Primary ContactEmilia Moreira, Msc
Backup ContactJamil Natour
Outcome results
None listed