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

NCT ID: NCT00809640

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Keywords

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low back pain prevention schoolchildren education campaign

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Education (Back Comic-Book)

Intervention Type BEHAVIORAL

Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.

2

The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education (Back Comic-Book)

Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kovacs Foundation

Principal Investigators

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Francisco M Kovacs, MD, PhD

Role: STUDY_DIRECTOR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Mario Gestoso, MD

Role: PRINCIPAL_INVESTIGATOR

Kovacs Foundation,Palma de Mallorca, Spain

Locations

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Kovacs Foundation

Palma de Mallorca, Balearic Islands, Spain

Site Status

Countries

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Spain

Other Identifiers

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FK 27

Identifier Type: -

Identifier Source: org_study_id