NCT00666419

Brief Summary

A large study in Mallorca, Spain showed that nonspecific low back pain is quite prevalent in adolescents 13-15 years of age (Kovacs, 2003). Since below the age of seven years hardly any child has suffered low back pain, the purpose of this study is to determine the prevalence of low back pain in children 10-12 years of age, and to investigate the risk factors associated with its occurrence.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

April 23, 2008

Last Update Submit

August 22, 2019

Conditions

Keywords

nonspecific low back painschoolchildrenprevalence

Interventions

10-12 year old schoolchildren will be weighed, measured for height, and tested for strength of their abdominal and paravertebral muscles

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All 10-12 year old schoolchildren on the island of Mallorca, Spain

You may qualify if:

  • Schoolchildren born in the years 1993, 1994 or 1995
  • Attending schools (public, concerted or private) in Mallorca
  • Can read and write Spanish

You may not qualify if:

  • Nor attending class on the days when the study is being done

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Related Publications (3)

  • Balague F, Troussier B, Salminen JJ. Non-specific low back pain in children and adolescents: risk factors. Eur Spine J. 1999;8(6):429-38. doi: 10.1007/s005860050201.

    PMID: 10664299BACKGROUND
  • Kovacs FM, Gestoso M, Gil Del Real MT, Lopez J, Mufraggi N, Ignacio Mendez J. Risk factors for non-specific low back pain in schoolchildren and their parents: a population based study. Pain. 2003 Jun;103(3):259-268. doi: 10.1016/S0304-3959(02)00454-2.

    PMID: 12791432BACKGROUND
  • Gil del RealMT, Kovacs FM, Gestoso M, Mufraggi N, Diéguez JM. Evaluation of two questionnaires to determine exposure to risk factors for non-specific low back pain in Mallorcan schoolchildren and their parents. European Journal of Public Health 9(3): 194-199, 1999.

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Francisco M Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, 07012, Spain

    STUDY DIRECTOR
  • Pere Palou, PhD

    Universitat de les Illes Balears, Palma de Mallorca, Spain

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Spanish Back Pain Research Network (REIDE)

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 24, 2008

Study Start

September 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations