Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
MODIC
1 other identifier
observational
487
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 28, 2011
June 1, 2011
2.3 years
May 24, 2007
June 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modic change
Modic change type, extension and volume
Upon assessment
Secondary Outcomes (2)
Patients' characteristics
Upon assessment
Image features
Upon assessment
Eligibility Criteria
Patients seen for chronic low back pain at the hospitals of the Spanish National Health Service.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kovacs Foundation
Palma de Mallorca, Balearic Islands, 07012, Spain
Related Publications (3)
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.
PMID: 3336678BACKGROUNDToyone 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.
PMID: 8083266BACKGROUNDStirling 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.
PMID: 11438138BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francisco M Kovacs, MD, PhD
Kovacs Foundation, Palma de Mallorca, Spain
- PRINCIPAL INVESTIGATOR
Carlos Campillo, MD
IbSalut, Palma de Mallorca, Spain
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
May 1, 2008
Primary Completion
September 1, 2010
Study Completion
January 1, 2011
Last Updated
June 28, 2011
Record last verified: 2011-06