Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00721318
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2008-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-23', 'studyFirstSubmitDate': '2008-07-22', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic widespread pain', 'fibromyalgia', 'rheumatoid arthritis', 'Estonia'], 'conditions': ['Chronic Widespread Pain']}, 'descriptionModule': {'briefSummary': "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.\n\nSo far, there are no data on the prevalence of the CWP and FM in Estonia available.\n\nThe 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.\n\nAt 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.\n\nPerforming the study will provide an experience which forms the base for further epidemiological and clinical research on CWP and FM"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population: Tallinn and Harju County (Estonia), population 552,000. The residents of both Tallinn and Harju County receive national health care services.', 'healthyVolunteers': False, 'eligibilityCriteria': "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\n\nThe 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.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT00721318', 'briefTitle': 'A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County', 'organization': {'class': 'OTHER', 'fullName': 'Estonian Society for Rheumatology'}, 'officialTitle': 'A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population Matched by Gender, Age and Place of Residence in Tallinn and Harjumaa County', 'orgStudyIdInfo': {'id': 'Merck35016'}, 'secondaryIdInfos': [{'id': '35016'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients diagnosed with rheumatoid arthritis'}, {'label': '2', 'description': 'Population controls to the subjects of group 1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10138', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'East Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Estonian Society for Rheumatology', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kati Otsa, MD', 'oldOrganization': 'Estonian Society for Rheumatology'}}}}