Low Back Pain
Conditions
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
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%.
Interventions
OTHERGraded Activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
OTHERSupervised 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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 6 weeks | Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire |
| Functional Disability | 6 weeks | Roland Morris Disability Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Quality of life | 6 weeks | Short-Form Health Survey Questionnaire |
| 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. |
| Physical Capacity | 6 weeks | physical capacity tests (sit-to-stand and 50-foot walk) |
| Global Perceived Effect | 6 weeks | Global Perceived Effect Scale |
Countries
Brazil
Outcome results
None listed