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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00721318
Other study ID # Merck35016
Secondary ID 35016
Status Active, not recruiting
Phase N/A
First received July 22, 2008
Last updated July 23, 2008
Start date May 2008
Est. completion date May 2010

Study information

Verified date July 2008
Source Estonian Society for Rheumatology
Contact n/a
Is FDA regulated No
Health authority Estonia: The State Agency of Medicine
Study type Observational

Clinical Trial Summary

The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the same time they are not life threatening and they cannot be detected by any laboratory tests. The problems connected with these conditions have gained little attention in Estonia so far. It can be assumed that the CWP and FM often remain undetected and the sufferers live without treatment they need.

So far, there are no data on the prevalence of the CWP and FM in Estonia available.

The goal of the current research is to assess the prevalence of the CWP and local pain syndromes among Estonia's RA patients and among the control population in Tallinn and Harju County; also the factors connected with the presence of the pain and the pain treatment in use.

At the same time there will be a similarly designed research conducted in Jyväskylä Central Hospital, which provides the opportunity to compare results in Estonia's and Finland's research groups. The study on the distribution of the chronic pain among RA patients and control population will allow to assess the magnitude of the problem in Estonia and to raise the awareness of physicians about CWP and significance of its treatment.

Performing the study will provide an experience which forms the base for further epidemiological and clinical research on CWP and FM


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6000
Est. completion date May 2010
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 2000 RA patients from the East Tallinn Central Hospital's and the North Estonian Regional Hospital's in- and outpatients who live in Tallinn or Harju County

The control sample will be found from the Population Register through matching by gender, age (the same year) and place of residence (living in the city or in the countryside) with the subjects from RA sample according to the official procedure. If required, the research subjects from the control sample will be contacted by a rheumatologist participating in the study.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Estonia East Tallinn Central Hospital Tallinn

Sponsors (1)

Lead Sponsor Collaborator
Estonian Society for Rheumatology

Country where clinical trial is conducted

Estonia, 

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