Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients

Completed

• Conditions: Low Back Pain

• Registration Number: NCT00478868
• Lead Sponsor: Kovacs Foundation

Brief 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).

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-25
• Study Start: 2008-05
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-26
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 487

Inclusion Criteria

• Patients between 35 and 50 years of age having a diagnosis of chronic low back pain (of 3 or more months' duration, and including sciatica and lumbar cytalgia), who get a prescription for an MRI.

Exclusion Criteria

• Racial characteristics suggesting a non-Spanish origin; central nervous system pathology (with or without treatment);
• Diagnosis or suspicion of systemic disease (inflammatory disease such as rheumatoid arthritis, or infections).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modic change	Upon assessment	Modic change type, extension and volume

Secondary Outcome Measures

Name	Time	Method
Patients' characteristics	Upon assessment	Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity
Image features	Upon assessment	Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis

Trial Locations

Locations (1)

Kovacs Foundation; 🇪🇸 Palma de Mallorca, Balearic Islands, Spain