Back to resultsActive Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Education (Back Comic-Book)
Sponsored by
About this trial
This is an interventional prevention trial for Low Back Pain focused on measuring low back pain, prevention, schoolchildren, education campaign
Eligibility 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
Sites / Locations
- Kovacs Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
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.
The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment.
Outcomes
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.
Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00809640
Brief Title
Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
Official Title
Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kovacs Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, prevention, schoolchildren, education campaign
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment.
Intervention Type
Behavioral
Intervention Name(s)
Education (Back Comic-Book)
Intervention Description
Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco M Kovacs, MD, PhD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mario Gestoso, MD
Organizational Affiliation
Kovacs Foundation,Palma de Mallorca, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kovacs Foundation
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07012
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
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