Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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%.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Graded Activity Exercise treadmill, Strengthening of the lower limbs and trunk |
Other: Graded Activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
Other: Supervised Exercises
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.
|
| Active Comparator: Supervised exercises Stretching, Strengthening, Motor Control |
Other: Graded Activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
Other: Supervised Exercises
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.
|
Outcome Measures
Primary Outcome Measures
- Pain [6 weeks]
Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
- Functional Disability [6 weeks]
Roland Morris Disability Questionnaire
Secondary Outcome Measures
- Quality of life [6 weeks]
Short-Form Health Survey Questionnaire
- Global Perceived Effect [6 weeks]
Global Perceived Effect Scale
- Return to work [6 weeks]
Patients will be asked if returned their professional activities.
- Habitual physical activity [6 weeks]
The Baecke questionnaire on habitual physical activity
- Physical Capacity [6 weeks]
physical capacity tests (sit-to-stand and 50-foot walk)
- Kinesiophobia [Tampa Scale of Kinesophobia (TSK)]
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.
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medicine School of the University Of São Paulo | São Paulo | Brazil | 01246903 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Study Director: Amelia P Marques, PHD, University of São Paulo
- Principal Investigator: Mauricio O Magalhaes, MSc, University of São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- mauriciomag20