NCT00439764
Completed
Phase 2
Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
Kovacs Foundation1 site in 1 country680 target enrollmentMarch 2007
ConditionsLow Back Pain
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Kovacs Foundation
- Enrollment
- 680
- Locations
- 1
- Primary Endpoint
- Intensity of pain, measured at baseline, 90, and 180 days later
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.
Exclusion Criteria
- •Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
- •Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
- •Suspicion of fibromyalgia.
Outcomes
Primary Outcomes
Intensity of pain, measured at baseline, 90, and 180 days later
Time Frame: 6 months
Disability, measured at baseline, 90, and 180 days later
Time Frame: 6 months
Sick leave, measured at baseline, 90, and 180 days later
Time Frame: 6 months
Secondary Outcomes
- Fear avoidance beliefs, measured at baseline, 90, and 180 days later(6 months)
- Quality of life, measured at baseline, 90, and 180 days later(6 months)
Study Sites (1)
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