Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 8:05 PM
Study NCT ID:
NCT06825195
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fingertip Precision Pinch Force in Fibromyalgia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'minimum pinch force', 'timeFrame': 'November 2024- January 2025', 'description': 'minimum fingertip pinch force required to hold a constant weight'}, {'measure': 'maximum pinch force', 'timeFrame': 'November 2024- January 2025', 'description': 'maximum fingertip pinch force required to hold a constant weight'}, {'measure': '% Minimum/maksimum pinch force', 'timeFrame': 'November 2024- January 2025', 'description': 'percentage of minimum holding force to maximum holding force'}], 'secondaryOutcomes': [{'measure': 'isokinetik muscle strength', 'timeFrame': 'November 2024- January 2025', 'description': 'Wrist isokinetic extensor and flexor peak torque at 180 degrees/sec'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromiyalgia', 'Muscle Strength', 'Fatigue'], 'conditions': ['Fibromyalgia', 'Force Measurement', 'Isokinetic', 'Muscle Strength']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the force used by fibromyalgia patients during a task compared to healthy volunteers and to evaluate its relationship with fatigue seen in these patients.', 'detailedDescription': 'Fatigue is a common symptom in fibromyalgia patients and it is known that these patients have decreased muscle strength compared to healthy volunteers. The aim of this study was to evaluate whether the minimum force to be applied during carrying is different in fibromyalgia patients compared to healthy volunteers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with fibromyalgia diagnosis and no accompanying rheumatological disease', 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Female patients diagnosed with fibromyalgia between the ages of 18-70\n\nExclusion Criteria:\n\n* Those whose treatment has been changed in the last month\n* Those with shoulder, elbow, wrist and hand diseases that may cause pain in the dominant upper extremity\n* Those with carpal or cubital tunnel syndrome\n* Those with a history of orthopedic surgery in the dominant extremity\n* Those with uncontrolled metabolic disease\n* Those with B12 deficiency'}, 'identificationModule': {'nctId': 'NCT06825195', 'briefTitle': 'Evaluation of Fingertip Precision Pinch Force in Fibromyalgia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Evaluation of Fingertip Precision Pinch Force During Carrying in Fibromyalgia Patients.', 'orgStudyIdInfo': {'id': 'Fibromiyalgia1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibromiyalgia', 'description': 'Fibromiyalgia Patients', 'interventionNames': ['Other: isokinetic muscle strength measurement', 'Other: Minimum pinch force measurement']}, {'label': 'Healthy Control', 'description': 'Healthy control group', 'interventionNames': ['Other: isokinetic muscle strength measurement', 'Other: Minimum pinch force measurement']}], 'interventions': [{'name': 'isokinetic muscle strength measurement', 'type': 'OTHER', 'description': 'Wrist isokinetic eccentric flexor and extensor peak Torque and fatigue will be measured at the angular velocity of 180°/s', 'armGroupLabels': ['Fibromiyalgia', 'Healthy Control']}, {'name': 'Minimum pinch force measurement', 'type': 'OTHER', 'description': 'the minimum fingertip pinch force required to hold a constant weight will be measured', 'armGroupLabels': ['Fibromiyalgia', 'Healthy Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dilara Ekici Zincirci', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Dilara Ekici Zincirci', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}