Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-29 @ 2:34 AM
Study NCT ID:
NCT03757702
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2018-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trunk Position Sense, Postural Stability and Spinal Posture in 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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-19', 'studyFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint Position Sense', 'timeFrame': '20 days', 'description': 'Trunk position sense will be evaluated with a digital inclinometer.'}], 'secondaryOutcomes': [{'measure': 'Postural Stability', 'timeFrame': '20 days', 'description': 'The postural stability will be evaluated with a special balance device in eyes opened and closed position.'}, {'measure': 'Spinal Posture', 'timeFrame': '20 days', 'description': '.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Postural Lordosis', 'Postural Kyphosis', 'Proprioception', 'Postural Stability', 'Balance']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy women and Fibromyalgia patient', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being women\n* having FMS\n* being volunteer\n\nExclusion Criteria:\n\n* have neurologic, infectious, endocrine, and other severe psychological disorders\n* malignancy,\n* being pregnant\n* any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems)\n* spinal deformities such as scoliosis, spine surgery\n* inflammatory rheumatic diseases'}, 'identificationModule': {'nctId': 'NCT03757702', 'briefTitle': 'Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Investigation of Trunk Position Sense, Postural Stability and Posture in Fibromyalgia Patients and Healthy Women', 'orgStudyIdInfo': {'id': '43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibromiyalgia group', 'description': 'women with FMS between 18-65 years of age and being volunteered.', 'interventionNames': ['Other: Evaluation']}, {'label': 'Healthy group', 'description': 'healthy women and being volunteereed', 'interventionNames': ['Other: Evaluation']}], 'interventions': [{'name': 'Evaluation', 'type': 'OTHER', 'description': 'Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.', 'armGroupLabels': ['Fibromiyalgia group', 'Healthy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yıldırım Beyazıt University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Özge Çoban', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Assitant'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}