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Prevalence of Fibromyalgia in Israel

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Fibromyalgia focused on measuring Fibromyalgia, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals over 18 who consent to answer the survey questions

Sites / Locations

  • Tel Aviv SOurasky Medical centerRecruiting

Outcomes

Primary Outcome Measures

Prevalence of fibromyalgia in the Israeli population

Secondary Outcome Measures

Demographic data on fibromyalgia patients

Full Information

First Posted
September 15, 2010
Last Updated
October 10, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01203865
Brief Title
Prevalence of Fibromyalgia in Israel
Official Title
Prevalence of Fibromyalgia in Israel
Study Type
Observational

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Fatigue

7. Study Design

Enrollment
1200 (Anticipated)
Primary Outcome Measure Information:
Title
Prevalence of fibromyalgia in the Israeli population
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Demographic data on fibromyalgia patients
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals over 18 who consent to answer the survey questions
Study Population Description
Telephone survey - general population over age 18 Rheumatology patients - patients attending the rheumatology clinic for any reason
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob N Ablin, MD
Phone
972-3-6973668
Email
jacobab@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob N Ablin, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv SOurasky Medical center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob N Ablin, MD
Phone
972-3-6973668
Email
jacobab@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Jacob N Ablin, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19250656
Citation
Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere 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.
Results Reference
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Prevalence of Fibromyalgia in Israel

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