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

This study has been completed.
Sponsor:
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00809640
First received: December 15, 2008
Last updated: December 4, 2009
Last verified: December 2009
  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 April 17, 2014