Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
This study has been completed.
Sponsor:
Kovacs Foundation
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00809640
First received: December 15, 2008
Last updated: December 4, 2009
Last verified: December 2009
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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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren |
Resource links provided by NLM:
Further study details as provided by Kovacs Foundation:
Primary Outcome Measures:
- Assessment of the effectiveness of a prevention campaign promoting active management of low back pain in shifting beliefs in 6 to 8 year old schoolchildren. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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.
|
|
No Intervention: 2
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 |
Criteria
Inclusion Criteria:
- Students in randomly selected private, public and concerted Majorca schools
- Must be present in class on day of intervention and assessments
Exclusion Criteria:
- Absent from class on day of intervention and assessments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809640
Locations
| Spain | |
| Kovacs Foundation | |
| Palma de Mallorca, Balearic Islands, Spain, 07012 | |
Sponsors and Collaborators
Kovacs Foundation
Investigators
| 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
No publications provided
| Responsible Party: | Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation |
| ClinicalTrials.gov Identifier: | NCT00809640 History of Changes |
| Other Study ID Numbers: | FK 27 |
| Study First Received: | December 15, 2008 |
| Last Updated: | December 4, 2009 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica Spain: Fiscalía de Menores de les Illes Balears |
Keywords provided by Kovacs Foundation:
|
low back pain prevention schoolchildren education campaign |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013