Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Behavioral: General health talk; Behavioral: Handout of The Back Book; Behavioral: Back exercise

• Registration Number: NCT00439764
• Lead Sponsor: Kovacs Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-26
• Study Start: 2007-03
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	General health talk	Routine clinical practice and talk on general health
1	Handout of The Back Book	Routine clinical practice and talk on general health
1	Back exercise	Routine clinical practice and talk on general health
2	Handout of The Back Book	Talk on back health and handout of The Back Book
2	Back exercise	Talk on back health and handout of The Back Book
3	Back exercise	Routine clinical practice, talk on back health, handout of The Back Book and back exercise

Primary Outcome Measures

Name	Time	Method
Intensity of pain, measured at baseline, 90, and 180 days later	6 months
Disability, measured at baseline, 90, and 180 days later	6 months
Sick leave, measured at baseline, 90, and 180 days later	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Servicio de Atención Primaria del SACYL; 🇪🇸 Valladolid, Castilla y León, Spain