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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478868
First Posted: May 25, 2007
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kovacs Foundation
May 24, 2007
May 25, 2007
June 28, 2011
May 2008
September 2010   (Final data collection date for primary outcome measure)
Modic change [ Time Frame: Upon assessment ]
Modic change type, extension and volume
Not Provided
Complete list of historical versions of study NCT00478868 on ClinicalTrials.gov Archive Site
  • Patients' characteristics [ Time Frame: Upon assessment ]
    Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity
  • Image features [ Time Frame: Upon assessment ]
    Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis
Not Provided
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Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
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.

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).

Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample
Patients seen for chronic low back pain at the hospitals of the Spanish National Health Service.
Low Back Pain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
January 2011
September 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
35 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00478868
FK-R-15
Yes
Not Provided
Not Provided
Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
Kovacs Foundation
Not Provided
Study Director: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, Spain
Principal Investigator: Carlos Campillo, MD IbSalut, Palma de Mallorca, Spain
Kovacs Foundation
June 2011