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Status unknownNCT00658060Updated Apr 14, 2008

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

An observational study in Familial Mediterranean Fever, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-14.

Sponsored by Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2008), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Familial Mediterranean Fever

Keywords

  • FMF, Exertional leg pain
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In context

Familial Mediterranean Fever

61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.

This study's planned enrollment of 20 is below the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.

Browse Familial Mediterranean Fever studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 for MRI.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. change in spectroscopic appearance of muscle after exertion of muscle thigh

    Time frame: 1 hour

Secondary outcomes

  1. change in muscle intensity signal after exertion

    Time frame: 1 hour

  2. change in joint effusion status after exertion

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • Sheba Medical Center
    Ramat Gan, 52621, Israel
    Recruiting
    • Iris Eshed · Contact
08

References and documents

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. PubMed 11407703 ↗
  • 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. PubMed 16585908 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00658060
First posted
Apr 14, 2008
Start date
Sep 2007
Last update
Apr 14, 2008

Study contacts

Merav Lidar, MD
Contact
merav.lidar@sheba.health.gov.il
+972-54-4721675
Iris Eshed, MD
principal investigator · Sheba Medical Center
Tammi Kushnir, PhD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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