Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain

Detailed Description
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Objective: To contrast the efficacy of of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain Design: Sixty-six will be randomized into two groups namely: Graded Activity program (GA)(n = 33) and supervised exercise (SE) (n = 33). The primary clinical outcomes will be pain, assessed with the numerical pain scale and McGill Pain Questionnaire, and disability assessed with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with Global Perceived Effect, quality of life, return to work, physical activity, functional capacity and strength of the lower limbs. The program lasts for 6 weeks, and sessions happen twice a week, with duration of one hour each. Evaluations will be performed before(baseline), after (6weeks) and with a follow-up 3 and 6 months after treatment. Data will be collected by a blinded examiner who also had made the allocation of patients to groups. Significance level is established at 5%.

Official Title
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EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Graded Activity
* Other: Supervised Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-specific chronic low back pain for at least three months, age between 18 and 65 year of both genders and with a minimum pain intensity score of three in the 11-point Pain Numerical Rating Scale (ranging from 0 to 10 points). Exclusion Criteria: Known or suspected serious spinal pathology (fractures, tumors, inflammatory or infective diseases of the spine); Nerve root compromise; Comorbid health conditions that would prevent active participation in the exercise programs; Pregnancy; Cardio Respiratory illnesses;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Graded Activity<br>Exercise treadmill, Strengthening of the lower limbs and trunk | Other: Graded Activity<br>* The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.<br>Other: Supervised Exercises<br>* The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.<br>|
| Active Comparator: Supervised exercises<br>Stretching, Strengthening, Motor Control | Other: Graded Activity<br>* The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.<br>Other: Supervised Exercises<br>* The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire | 6 weeks | 
| Functional Disability | Roland Morris Disability Questionnaire | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Short-Form Health Survey Questionnaire | 6 weeks | 
| Global Perceived Effect | Global Perceived Effect Scale | 6 weeks | 
| Return to work | Patients will be asked if returned their professional activities. | 6 weeks | 
| Habitual physical activity | The Baecke questionnaire on habitual physical activity | 6 weeks | 
| Physical Capacity | physical capacity tests (sit-to-stand and 50-foot walk) | 6 weeks | 
| Kinesiophobia | self-applied questionnaire consisting of 17 items, which was developed to measure the fear of movement due to cLBP. Each question has 4 response options (strongly disagree, disagree, agree, and strongly agree) with scores respectively ranging from 1 to 4 points. | Tampa Scale of Kinesophobia (TSK) |