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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: April 8, 2008
Last updated: April 11, 2008
Last verified: April 2008

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.

Familial Mediterranean Fever

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • change in spectroscopic appearance of muscle after exertion of muscle thigh [ Time Frame: 1 hour ]

Secondary Outcome Measures:
  • change in muscle intensity signal after exertion [ Time Frame: 1 hour ]
  • change in joint effusion status after exertion [ Time Frame: 1 hour ]

Estimated Enrollment: 20
Study Start Date: September 2007
  • 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

Control group

  • 1.Healthy subjects
  • 2.18-45 years old
  • 3.Non-smokers


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00658060

Contact: Merav Lidar, MD +972-54-4721675

Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Iris Eshed         
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Iris Eshed, MD Sheba Medical Center
Principal Investigator: Tammi Kushnir, PhD Sheba Medical Center
  More Information

Responsible Party: Eshed Iris, MD, Sheba Medical Center Identifier: NCT00658060     History of Changes
Other Study ID Numbers: SHEBA-07-4632-IE-CTIL
Study First Received: April 8, 2008
Last Updated: April 11, 2008

Keywords provided by Sheba Medical Center:
FMF, Exertional leg pain

Additional relevant MeSH terms:
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Body Temperature Changes
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases processed this record on May 25, 2017