Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients (MODIC)
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.
Low Back Pain
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients|
- Modic change [ Time Frame: Upon assessment ] [ Designated as safety issue: No ]Modic change type, extension and volume
- Patients' characteristics [ Time Frame: Upon assessment ] [ Designated as safety issue: No ]Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity
- Image features [ Time Frame: Upon assessment ] [ Designated as safety issue: No ]Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis
|Study Start Date:||May 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478868
|Palma de Mallorca, Balearic Islands, Spain, 07012|
|Study Director:||Francisco M Kovacs, MD, PhD||Kovacs Foundation, Palma de Mallorca, Spain|
|Principal Investigator:||Carlos Campillo, MD||IbSalut, Palma de Mallorca, Spain|