Low Back PainNCT00666419
Prevalence of Back Pain and Associated Risk Factors in 10-12 Year Old Schoolchildren
An observational study of Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Measurement, weight, and muscle strength test
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2006to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All 10-12 year old schoolchildren on the island of Mallorca, Spain
Who may be able to join
- Schoolchildren born in the years 1993, 1994 or 1995
- Attending schools (public, concerted or private) in Mallorca
- Can read and write Spanish
Who cannot join
- Nor attending class on the days when the study is being done
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- Measurement, weight, and muscle strength test
- Keywords
- nonspecific low back pain, schoolchildren, prevalence
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement, weight, and muscle strength testOther
10-12 year old schoolchildren will be weighed, measured for height, and tested for strength of their abdominal and paravertebral muscles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startSep 2006
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Recruiting at schools was slower than planned. Missing data higher than acceptable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de les Illes Balears
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainPere Palou, PhD, Principal investigator, Universitat de les Illes Balears, Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666419
- Sponsor's protocol ID
- FK-UIB-23
- Status last verified
- Aug 2019
- First submitted
- 23 Apr 2008
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10664299Kovacs 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.
PubMed 12791432Gil 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Back Pain and Associated Risk Factors in 10-12 Year Old Schoolchildren
- ClinicalTrials.gov ID
- NCT00666419
- Acronym / sponsor ID
- FK-UIB-23
- Conditions
- Low Back Pain
- Keywords
- nonspecific low back pain, schoolchildren, prevalence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruiting at schools was slower than planned. Missing data higher than acceptable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Universitat de les Illes Balears
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All 10-12 year old schoolchildren on the island of Mallorca, Spain
Key inclusion criteria (3 listed)
- Schoolchildren born in the years 1993, 1994 or 1995
- Attending schools (public, concerted or private) in Mallorca
- Can read and write Spanish
Key exclusion criteria (1 listed)
- Nor attending class on the days when the study is being done
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement, weight, and muscle strength test10-12 year old schoolchildren will be weighed, measured for height, and tested for strength of their abdominal and paravertebral muscles | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 10664299Balague 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.
- Background: PubMed 12791432Kovacs 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.
- BackgroundGil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Kovacs, MD, PhD study director
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Pere Palou, PhD principal investigator
Universitat de les Illes Balears, Palma de Mallorca, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666419, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.