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Sponsors and Collaborators: |
Kovacs Foundation Conseill Insular de Ibiza y Formentera Instituto de Asuntos Sociales y Deportes de Mallorca |
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Information provided by: | Kovacs Foundation |
ClinicalTrials.gov Identifier: | NCT00441038 |
The primary purpose of this study is to compare, in retired persons living in the Balearic Islands, the effectiveness on low back pain related disability of three educational programs. All consist of a group talk and the handout of a booklet, each one different in its content.
Condition | Intervention | Phase |
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Low Back Pain |
Behavioral: The Back Guide Behavioral: The Back Book Behavioral: Cardiovascular and general health |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Controlled Randomized Clinical Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons |
Enrollment: | 1100 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Education on postural hygiene and handout of The Back Guide
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Behavioral: The Back Guide
Education on postural hygiene and handout of The Back Guide
Behavioral: The Back Book
Education on active management and Handout of The Back Book
Behavioral: Cardiovascular and general health
Education on cardiovascular and general health
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2: Active Comparator
Education on active management and handout of The Back Book
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Behavioral: The Back Book
Education on active management and Handout of The Back Book
Behavioral: Cardiovascular and general health
Education on cardiovascular and general health
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3: Active Comparator
Education on cardiovascular and general health
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Behavioral: Cardiovascular and general health
Education on cardiovascular and general health
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Spain, Balearic Islands | |
Kovacs Foundation | |
Palma de Mallorca, Balearic Islands, Spain, 07012 |
Study Director: | Francisco M. Kovacs, MD, PhD | Kovacs Foundation, Palma de Mallorca, Spain |
Principal Investigator: | Juan Noguera, MD | Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain |
Responsible Party: | Kovacs Foundation ( Francisco M. Kovacs, Director of Scientific Department ) |
Study ID Numbers: | FK-R-13 |
Study First Received: | February 23, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00441038 |
Health Authority: | Spain: Spanish Back Pain Research Network (REIDE) |
Low back pain disability health education |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Nervous System Diseases |