Viewing Study NCT00479063



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Study NCT ID: NCT00479063
Status: COMPLETED
Last Update Posted: 2011-06-28
First Post: 2007-05-24

Brief Title: Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects
Sponsor: Kovacs Foundation
Organization: Kovacs Foundation

Study Overview

Official Title: Modic Changes Are Not Associated With a Higher Risk of Chronic Low Back Pain Among Southern European Subjects A Case Control Study
Status: COMPLETED
Status Verified Date: 2011-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MODIC 2
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None