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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
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graded Activity | Active Comparator | Exercise treadmill, Strengthening of the lower limbs and trunk |
|
| Supervised exercises | Active Comparator | Stretching, Strengthening, Motor Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graded Activity | Other | The graded activity program to increase activity tolerance by performing individualized and submaximal exercises. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire | 6 weeks |
| Functional Disability | Roland Morris Disability Questionnaire | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Short-Form Health Survey Questionnaire | 6 weeks |
| Global Perceived Effect | Global Perceived Effect Scale | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Known or suspected serious spinal pathology (fractures, tumors, inflammatory or infective diseases of the spine);
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| Name | Affiliation | Role |
|---|---|---|
| Amelia P Marques, PHD | University of Sao Paulo | Study Director |
| Mauricio O Magalhaes, MSc | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine School of the University Of São Paulo | São Paulo | São Paulo | 01246903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23336703 | Derived | Magalhaes MO, Franca FJ, Burke TN, Ramos LA, de Moura Campos Carvalho e Silva AP, Almeida GP, Yuan SL, Marques AP. Efficacy of graded activity versus supervised exercises in patients with chronic non-specific low back pain: protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2013 Jan 21;14:36. doi: 10.1186/1471-2474-14-36. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Supervised Exercises | Other | 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. |
|
| 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |