Efficacy of Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain: Protocol of a Randomised Controlled Trial
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Purpose
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 | Intervention |
|---|---|
|
Low Back Pain |
Other: Graded Activity Other: Supervised Exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL |
- Pain [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
- Functional Disability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Roland Morris Disability Questionnaire
- Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Short-Form Health Survey Questionnaire
- Global Perceived Effect [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Global Perceived Effect Scale
- Return to work [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Patients will be asked if returned their professional activities.
- Habitual physical activity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]The Baecke questionnaire on habitual physical activity
- Physical Capacity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]physical capacity tests (sit-to-stand and 50-foot walk)
- Muscle Strength of Lower limbs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Handheld dynamometer to assess the strength of the knee flexors and extensors.
| Estimated Enrollment: | 66 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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%.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Mauricio O Magalhaes, MSc | +55 11 980901818 | mauriciomag20@gmail.com |
| Brazil | |
| Medicine School of the University Of São Paulo | Not yet recruiting |
| São Paulo, Brazil, 01246903 | |
| Contact: Mauricio O Magalhaes, MSc +55 11 981901818 mauriciomag20@gmail.com | |
| Principal Investigator: Mauricio O Magalhaes, MSc | |
| Medicine School of the University õf São Paulo | Not yet recruiting |
| São Paulo, Brazil, 01246903 | |
| Contact: Mauricio O Magalhaes, MSc +55 11 981901818 mauriciomag20@gmail.com | |
| Principal Investigator: Mauricio O Magalhães, MSc | |
| Study Director: | Amelia P Marques, PHD | University of São Paulo |
| Principal Investigator: | Mauricio O Magalhaes, MSc | University of São Paulo |
More Information
No publications provided by University of Sao Paulo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mauricio Oliveira Magalhães, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01719276 History of Changes |
| Other Study ID Numbers: | mauriciomag20 |
| Study First Received: | October 26, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013