Functional Exercises for Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Functional Exercise Protocol
* Other: Minimal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional exercise<br> | Other: Functional Exercise Protocol<br>* 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.<br>Other: Minimal<br>* Analgesic use when necessary and a single back scholl class<br>|
| Active Comparator: Control Group<br> | Other: Minimal<br>* Analgesic use when necessary and a single back scholl class<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back of pain intensity measured with Numeric Pain Rating Scale | 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. | Baseline, 6, 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability associated to low back pain measured with Oswestry Disability Index | Change in Oswestry Disability Index score | Baseline, 6, 12 and 24 weeks | 
| Disability associated to low back pain measured with Roland Morris Disability | Change in Roland Morris Disability score | Baseline, 6, 12 and 24 weeks | 
| Fear of movement measured with Fear-Avoidance Beliefs Questionnaire | Change in Fear-Avoidance Beliefs Questionnaire score | Baseline, 6, 12 and 24 weeks | 
| Quality of life measured with Short form-36 questionnaire | Change in Short form-36 questionnaire score | Baseline, 6, 12 and 24 weeks | 
| Function measured with the 6-minute walk test | Change in 6-minute walk test | Baseline, 6, 12 and 24 weeks | 
| Function measured with the timed to up and go test | Change in timed to up and go test | Baseline, 6, 12 and 24 weeks | 
| Patient's global impression of recovery measured with a likert scale | 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. | 6, 12 and 24 weeks after baseline | 
| Analgesic consumption | Change in analgesic consumption | 6, 12 and 24 weeks after baseline |