Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients (MODIC)
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|ClinicalTrials.gov Identifier: NCT00478868|
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : June 28, 2011
|Condition or disease|
|Low Back Pain|
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).
|Study Type :||Observational|
|Actual Enrollment :||487 participants|
|Official Title:||Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||January 2011|
- Modic change [ Time Frame: Upon assessment ]Modic change type, extension and volume
- Patients' characteristics [ Time Frame: Upon assessment ]Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity
- Image features [ Time Frame: Upon assessment ]Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|