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

• Conditions: Familial Mediterranean Fever

• Registration Number: NCT00658060
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2008-04
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Last Update Submitted: 2008-04-11
• Study First Posted: 2008-04-14
• Last Update Posted: 2008-04-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in spectroscopic appearance of muscle after exertion of muscle thigh	1 hour

Secondary Outcome Measures

Name	Time	Method
change in muscle intensity signal after exertion	1 hour
change in joint effusion status after exertion	1 hour

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel