Clinical trial NCT00478868: Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
Official title: Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: MODIC changes
chronic low back pain
magnetic resonance imaging (MRI)
vertebrae
intervertebral disc
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 487
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen for chronic low back pain at the hospitals of the Spanish National Health Service.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Modic change
timeFrame: Upon assessment
Secondary outcomes:
measure: Patients' characteristics
timeFrame: Upon assessment
measure: Image features
timeFrame: Upon assessment
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: IbSalut, Palma de Mallorca, Spain
name: Carlos Campillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9. doi: 10.1148/radiology.166.1.3336678.
citation: Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.
citation: Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available.