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

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

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.

Study Overview

• Status: Unknown
• Conditions: Familial Mediterranean Fever

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: Iris Eshed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with FMF, fulfilling the Tel Hashomer criteria for the diagnosis of FMF, 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
2; Control group; 1.Healthy subjects; 2.18-45 years old; 3.Non-smokers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Tammi Kushnir, PhD, Sheba Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 11, 2008
• First Posted (ESTIMATE): April 14, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2008
• Last Update Submitted That Met QC Criteria: April 11, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: FMF, Exertional leg pain
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Genetic; Body Temperature Changes; Fever; Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases
• Other Study ID Numbers: SHEBA-07-4632-IE-CTIL