Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects (MODIC 2)
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.
Low Back Pain
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Modic Changes Are Not Associated With a Higher Risk of Chronic Low Back Pain Among Southern European Subjects. A Case Control Study|
|Study Start Date:||February 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
All subjects screened for this study were aged 30 to 50 years, had been referred to participating Radiology services, and underwent a lumbar MRI. Cases had been referred for a lumbar MRI for LBP lasting > 90 days.
All subjects screened for this study were aged 30 to 50 years, had been referred to participating Radiology services, and underwent a lumbar MRI. Controls were headache patients who had been referred for a cranial MRI, which turned out to be normal, and who either had no history of LBP or had only experienced one episode in their life, which had lasted for less than 7 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479063
|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|