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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00658060

Enrollment

Registered

2008-04-14

Start date

2007-09-30

Completion date

Unknown

Last updated

2008-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Mediterranean Fever

Keywords

FMF, Exertional leg pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactMerav Lidar, MD

merav.lidar@sheba.health.gov.il+972-54-4721675

Outcome results