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Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects (MODIC 2)

This study has been completed.
Sponsor:
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00479063
First received: May 24, 2007
Last updated: June 26, 2011
Last verified: June 2011

May 24, 2007
June 26, 2011
February 2010
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00479063 on ClinicalTrials.gov Archive Site
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Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects
Modic Changes Are Not Associated With a Higher Risk of Chronic Low Back Pain Among Southern European Subjects. A Case Control Study

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Cases: chronic LBP patients aged 30-50 in whom a lumbar MRI had been prescribed. Controls: 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.

Low Back Pain
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  • Cases
    All subjects screened for this study were aged 30 to 50 years, had been referred to participating Radiology services, and underwent a lumbar MRI. Cases had been referred for a lumbar MRI for LBP lasting > 90 days.
  • Controls
    All subjects screened for this study were aged 30 to 50 years, had been referred to participating Radiology services, and underwent a lumbar MRI. Controls were headache patients who had been referred for a cranial MRI, which turned out to be normal, and who either had no history of LBP or had only experienced one episode in their life, which had lasted for less than 7 days.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
May 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • For all subjects: age between 35 and 50 years.
  • For subjects with LBP: having a diagnosis of chronic low back pain (of 3 or more months' duration) as the reason for an MRI.
  • For subjects without LBP: subjects with a cranial MRI (described as normal) for cephalalgia, and who had neither current LBP nor history of LBP.

Exclusion criteria were: history of spine surgery, current pregnancy, scoliosis with >15º curvature, vertebral fractures, "red flags" for potential underlying systemic diseases (oncologic disease during the previous 5 years, constitutional symptoms -unexplained weight loss, fever, chills-, history of intravenous drug use, or immunocompromised host), or signs suggesting cauda equine syndrome (relevant or progressive paresia, loss of sphincter control or saddle anesthesia).

Both
35 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00479063
FK-R-16
Yes
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP