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Clinical Trials/NCT00439764
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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
September 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kovacs Foundation

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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