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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809640
• Other study ID #: FK 27
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: December 4, 2009
• Start date: February 2009
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Fiscalía de Menores de les Illes Balears
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Education (Back Comic-Book)
Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.

Locations

Country	Name	City	State
Spain	Kovacs Foundation	Palma de Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 months	No
Primary	Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren.		4 months	No