Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients (MODIC)
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| First Received Date ICMJE | May 24, 2007 | ||||||||
| Last Updated Date | June 26, 2011 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Modic change [ Time Frame: Upon assessment ] [ Designated as safety issue: No ] Modic change type, extension and volume |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00478868 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients | ||||||||
| Official Title ICMJE | Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients | ||||||||
| 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. |
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| 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). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients seen for chronic low back pain at the hospitals of the Spanish National Health Service. |
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| Condition ICMJE | Low Back Pain | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 487 | ||||||||
| Completion Date | January 2011 | ||||||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Spain | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00478868 | ||||||||
| Other Study ID Numbers ICMJE | FK-R-15 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation | ||||||||
| Study Sponsor ICMJE | Kovacs Foundation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Kovacs Foundation | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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