Clinical trial NCT00658060: Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients
Official title: Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Mediterranean Fever
Keywords: FMF, Exertional leg pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: change in spectroscopic appearance of muscle after exertion of muscle thigh
timeFrame: 1 hour
Secondary outcomes:
measure: change in muscle intensity signal after exertion
timeFrame: 1 hour
measure: change in joint effusion status after exertion
timeFrame: 1 hour
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Iris Eshed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Tammi Kushnir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.