NCT00479063

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

Modic Changes Are Not Associated With a Higher Risk of Chronic Low Back Pain Among Southern European Subjects. A Case Control Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 304 (actual)
• Sponsor: Kovacs Foundation · Academic / Other
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2011-05-01
• First posted: 2007-05-25
• Last updated: 2011-06-28

Locations

1 site across 1 country: Spain