Functional Exercises for Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: Functional Exercise ProtocolOther: Minimal
- Registration Number
- NCT03376724
- Lead Sponsor
- Federal University of São Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Functional exercise Functional Exercise Protocol - Control Group Minimal - Functional exercise Minimal -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Fear of movement measured with Fear-Avoidance Beliefs Questionnaire Baseline, 6, 12 and 24 weeks Change in Fear-Avoidance Beliefs Questionnaire score
Function measured with the 6-minute walk test Baseline, 6, 12 and 24 weeks Change in 6-minute walk test
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
Disability associated to low back pain measured with Oswestry Disability Index Baseline, 6, 12 and 24 weeks Change in Oswestry Disability Index 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 Roland Morris Disability Baseline, 6, 12 and 24 weeks Change in Roland Morris Disability score
Trial Locations
- Locations (1)
Emilia Moreira
🇧🇷Sao Paulo, Brazil