Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients
NCT ID: NCT00658060
Last Updated: 2008-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2007-09-30
Brief Summary
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Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.
Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.
The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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1
* 1.Fulfilling the Tel Hashomer criteria for the diagnosis of FMF \[5\].
* 2.Suffering from episodes of exertional leg pain and or exertional ankle edema
* 3.18-45 years old
* 4.On a stable (≥ 2 weeks) dose of oral colchicine therapy
* 5.Non-smokers
No interventions assigned to this group
2
Control group
* 1.Healthy subjects
* 2.18-45 years old
* 3.Non-smokers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Suffering from episodes of exertional leg pain and or exertional ankle edema
3. 18-45 years old
4. On a stable (≥ 2 weeks) dose of oral colchicine therapy
5. Non-smokers
Exclusion Criteria
2. Suffering from muscular or neurological diseases not related to FMF
3. With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.
4. Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.
18 Years
45 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Sheba Medical Center
Principal Investigators
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Iris Eshed, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Tammi Kushnir, PhD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Iris Eshed
Role: primary
References
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Brik R, Shinawi M, Kasinetz L, Gershoni-Baruch R. The musculoskeletal manifestations of familial Mediterranean fever in children genetically diagnosed with the disease. Arthritis Rheum. 2001 Jun;44(6):1416-9. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-6.
Bendahan D, Mattei JP, Guis S, Kozak-Ribbens G, Cozzone PJ. [Non-invasive investigation of muscle function using 31P magnetic resonance spectroscopy and 1H MR imaging]. Rev Neurol (Paris). 2006 Apr;162(4):467-84. doi: 10.1016/s0035-3787(06)75038-x. French.
Other Identifiers
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SHEBA-07-4632-IE-CTIL
Identifier Type: -
Identifier Source: org_study_id