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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00478868

Acronym

MODIC

Enrollment

487

Registered

2007-05-25

Start date

2008-05-31

Completion date

2011-01-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

MODIC changes, chronic low back pain, magnetic resonance imaging (MRI), vertebrae, intervertebral disc

Brief 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.

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).

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

35 Years to 50 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Modic change	Upon assessment	Modic change type, extension and volume

Secondary

Measure	Time frame	Description
Patients' characteristics	Upon assessment	Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity
Image features	Upon assessment	Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis

Countries

Spain

Outcome results