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

NCT00809640 | Completed DMC

• 1 other identifier: FK 27
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; prevention; schoolchildren; education campaign

Outcome Measures

Primary Outcomes (2)

• 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

• Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren.

  4 months

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

NO INTERVENTION

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

Interventions

Education (Back Comic-Book) BEHAVIORAL

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

1

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students in randomly selected private, public and concerted Majorca schools
• Must be present in class on day of intervention and assessments

You may not qualify if:

• Absent from class on day of intervention and assessments

Sponsors & Collaborators

• Kovacs Foundation: lead

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY DIRECTOR

• Mario Gestoso, MD

  Kovacs Foundation,Palma de Mallorca, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

ES (1)