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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01203865
Other study ID # 0303-10-TLV
Secondary ID WS573984
Status Recruiting
Phase N/A
First received September 15, 2010
Last updated October 10, 2011
Start date October 2010
Est. completion date March 2012

Study information

Verified date October 2011
Source Tel-Aviv Sourasky Medical Center
Contact Jacob N Ablin, MD
Phone 972-3-6973668
Email jacobab@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. In the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. For this purpose a two - stage process will be used. First, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. This survey will use the London Fibromyalgia Epidemiology Study Screening Questionnaire. Second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the positive predictive value of the London Fibromyalgia Epidemiology Study Screening Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date March 2012
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Individuals over 18 who consent to answer the survey questions

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Tel Aviv SOurasky Medical center Tel Aviv

Sponsors (2)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center Pfizer

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubère JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of fibromyalgia in the Israeli population 9 months No
Secondary Demographic data on fibromyalgia patients 9 months No
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