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.