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

This study has been completed.
Sponsor:
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00478868
First received: May 24, 2007
Last updated: June 26, 2011
Last verified: June 2011
  Purpose

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.


Condition
Low Back Pain

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients

Resource links provided by NLM:


Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • Modic change [ Time Frame: Upon assessment ] [ Designated as safety issue: No ]
    Modic change type, extension and volume


Secondary Outcome Measures:
  • Patients' characteristics [ Time Frame: Upon assessment ] [ Designated as safety issue: No ]
    Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity

  • Image features [ Time Frame: Upon assessment ] [ Designated as safety issue: No ]
    Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis


Enrollment: 487
Study Start Date: May 2008
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seen for chronic low back pain at the hospitals of the Spanish National Health Service.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478868

Locations
Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Sponsors and Collaborators
Kovacs Foundation
Investigators
Study Director: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, Spain
Principal Investigator: Carlos Campillo, MD IbSalut, Palma de Mallorca, Spain
  More Information

Publications:
Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00478868     History of Changes
Other Study ID Numbers: FK-R-15
Study First Received: May 24, 2007
Last Updated: June 26, 2011
Health Authority: Spain: Agencia Valenciana de Salud
Spain: Spanish Back Pain Research NEtwork

Keywords provided by Kovacs Foundation:
MODIC changes
chronic low back pain
magnetic resonance imaging (MRI)
vertebrae
intervertebral disc

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014