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| Sponsored by: |
Kovacs Foundation |
|---|---|
| Information provided by: | Kovacs Foundation |
| ClinicalTrials.gov Identifier: | NCT00809640 |
Purpose
The objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the study group the students will get a Back Comic-Book (promotes active management) after the first assessment. The control group will have no other intervention than the questionnaire.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Behavioral: Education (Back Comic-Book) |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study |
| Official Title: | Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren |
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
The intervention group will receive prevention of low back pain education through a Back Comic-Book, and their beliefs/knowledge will be tested twice after intervention.
|
Behavioral: Education (Back Comic-Book)
Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.
|
|
2: No Intervention
The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment.
|
Eligibility| Ages Eligible for Study: | 6 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Francisco M Kovacs, MD, PhD | +34 971 720809 | kovacs@kovacs.org |
| Contact: María Teresa Gil del Real, MPH | +34 91 3440244 | mtgildelreal@kovacs.org |
| Spain, Balearic Islands | |
| Kovacs Foundation | |
| Palma de Mallorca, Balearic Islands, Spain, 07012 | |
| Study Director: | Francisco M Kovacs, MD, PhD | Kovacs Foundation, Palma de Mallorca, 07012, Spain |
| Principal Investigator: | Mario Gestoso, MD | Kovacs Foundation,Palma de Mallorca, Spain |
More Information
| Responsible Party: | Kovacs Foundation ( Francisco M. Kovacs, Director of Scientific Department ) |
| Study ID Numbers: | FK 27 |
| Study First Received: | December 15, 2008 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00809640 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica; Spain: Fiscalía de Menores de les Illes Balears |
|
low back pain prevention schoolchildren education campaign prevention |
|
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
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Nervous System Diseases |
