Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients

Study Overview
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Brief Summary
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Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis. 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.

Official Title
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Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh

Conditions
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Familial Mediterranean Fever

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5]. Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (≥ 2 weeks) dose of oral colchicine therapy Non-smokers Exclusion Criteria: with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels. Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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 | |
| 2<br>Control group 1.Healthy subjects 2.18-45 years old 3.Non-smokers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in spectroscopic appearance of muscle after exertion of muscle thigh |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle intensity signal after exertion |  | 1 hour | 
| change in joint effusion status after exertion |  | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMF, Exertional leg pain