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Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren

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ClinicalTrials.gov Identifier: NCT00809640
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Kovacs Foundation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Behavioral: Education (Back Comic-Book) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00809640     History of Changes
Other Study ID Numbers: FK 27
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

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