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

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ClinicalTrials.gov Identifier: NCT00479063
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Low Back Pain

Study Design

Study Type : Observational
Actual Enrollment : 304 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Modic Changes Are Not Associated With a Higher Risk of Chronic Low Back Pain Among Southern European Subjects. A Case Control Study
Study Start Date : February 2010
Primary Completion Date : December 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479063


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: NCT00479063     History of Changes
Other Study ID Numbers: FK-R-16
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

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