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Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects

NCT00479063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 304

Last updated 2011-06-28

No results posted yet for this study

Summary

In this case-control study, cases were chronic LBP patients aged 30-50 in whom a lumbar MRI had been prescribed. Controls were subjects aged 30-50 in whom a cranial MRI had been prescribed for headache, who did not suffer from LBP and had no history of clinically relevant LBP. Two hundred and forty cases and 64 controls were recruited consecutively in Radiology services across six cities in Spain. Imaging findings and subjects' characteristics were gathered through previously validated instruments. Radiologists who interpreted MRIs were blinded to subjects' characteristics. A multivariate logistic regression model was developed to assess the association of Modic changes with LBP, adjusting for sex, age, body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.

Conditions

  • Low Back Pain

Sponsors & Collaborators

  • Kovacs Foundation

    lead OTHER

Principal Investigators

  • Francisco M Kovacs, MD, PhD · Kovacs Foundation, Palma de Mallorca, Spain

  • Carlos Campillo, MD · IbSalut, Palma de Mallorca, Spain

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-12-31
Completion
2011-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479063 on ClinicalTrials.gov