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

Low Back Pain Clinical Trial

— MODIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478868
• Other study ID #: FK-R-15
• Status: Completed
• Phase: N/A
• First received: May 24, 2007
• Last updated: June 26, 2011
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Valenciana de SaludSpain: Spanish Back Pain Research NEtwork
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 50 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Spain	Kovacs Foundation	Palma de Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9. — View Citation

Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. — View Citation

Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modic change	Modic change type, extension and volume	Upon assessment	No
Secondary	Patients' characteristics	Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity	Upon assessment	No
Secondary	Image features	Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis	Upon assessment	No