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OpenTrials
Completed

NCT Number: NCT00478868

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.

Completed

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Modic change

    Time frame: Upon assessment

    Modic change type, extension and volume

Secondary outcomes

  1. Patients' characteristics

    Time frame: Upon assessment

    Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity

  2. Image features

    Time frame: Upon assessment

    Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis

Sponsors and collaborators

Lead sponsor

Kovacs Foundation

Other

Registry information

Acronym: MODIC

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 25, 2007
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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