Clinical Trials Directory

Trials / Completed

CompletedNCT00478868

Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients

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

Summary

To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and radiological findings associated with Modic changes.

Detailed description

Ten radiologists from six hospitals across six cities in Spain, consecutively recruited 487 adult patients (263 women and 224 men) in whom lumbar MRI had been prescribed for low back pain lasting ≥ 3 months. Patients' characteristics and imaging findings were assessed through previously validated instruments. A multivariate logistic regression model was developed to assess the features associated with Modic changes. Outcome measures were: Gender, age, body mass index (BMI), life time smoking exposure, degree of physical activity, and image features (disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis).

Conditions

Timeline

Start date
2008-05-01
Primary completion
2010-09-01
Completion
2011-01-01
First posted
2007-05-25
Last updated
2011-06-28

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT00478868. Inclusion in this directory is not an endorsement.