Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-21 @ 7:29 AM
Study NCT ID:
NCT02449395
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2015-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-sectional Study of Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2015-05-02', 'studyFirstSubmitQcDate': '2015-05-16', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': 'up to 1 week'}], 'secondaryOutcomes': [{'measure': 'QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)', 'timeFrame': 'up to 1 week'}, {'measure': 'Pain scores as measured by Numerical rating scale (NRS)', 'timeFrame': 'up to 1 week'}, {'measure': 'Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)', 'timeFrame': 'up to 1 week'}, {'measure': 'Depression scores as measured by Beck depression inventory (BDI)', 'timeFrame': 'up to 1 week'}, {'measure': 'Stress scores as measured by Perceived Stress Scale (PSS)', 'timeFrame': 'up to 1 week'}, {'measure': 'Sleep scores as measured by Pittsburgh sleep quality index (PSQI)', 'timeFrame': 'up to 1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '39827119', 'type': 'DERIVED', 'citation': 'Wang Y, Liu P, Li Z, Wu S, Long M, Li Y, Jiao J, Xie Z. Quality of life, pain, depression, fatigue and sleep in patients with remission or mild fibromyalgia: a comparison with remission or low disease activity rheumatoid arthritis and healthy controls. BMC Musculoskelet Disord. 2025 Jan 18;26(1):67. doi: 10.1186/s12891-025-08323-6.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.', 'detailedDescription': "Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism. Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study will be conducted in Beijing, China."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients fulfilling 1990 ACR criterion for fibromyalgia be seen in the Fibromyalgia Outpatient Service which belonged to the Department of Rheumatism, Guang'anmen Hospital, Beijing China.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 years or older.\n* Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.\n\nExclusion Criteria:\n\n* Don't fulfill any classification criterions for Fibromyalgia."}, 'identificationModule': {'nctId': 'NCT02449395', 'briefTitle': 'Cross-sectional Study of Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'A Cross-sectional Study of Fibromyalgia in Beijing', 'orgStudyIdInfo': {'id': '39301'}}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Juan Jiao, M.D.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician', 'investigatorFullName': 'Juan Jiao', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}