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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: General health talk
* Behavioral: Handout of The Back Book
* Behavioral: Back exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Routine clinical practice and talk on general health | Behavioral: General health talk<br>* Routine clinical practice and talk on general health<br>Behavioral: Handout of The Back Book<br>* Talk on health of the back and handout of The Back Book<br>Behavioral: Back exercise<br>* Routine clinical practice, talk on back health, handout of The Back Book and back exercise<br>|
| Active Comparator: 2<br>Talk on back health and handout of The Back Book | Behavioral: Handout of The Back Book<br>* Talk on health of the back and handout of The Back Book<br>Behavioral: Back exercise<br>* Routine clinical practice, talk on back health, handout of The Back Book and back exercise<br>|
| Active Comparator: 3<br>Routine clinical practice, talk on back health, handout of The Back Book and back exercise | Behavioral: Back exercise<br>* Routine clinical practice, talk on back health, handout of The Back Book and back exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, health education, physical therapy