Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-30 @ 12:50 AM
Study NCT ID:
NCT05999266
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-08-13', 'studyFirstSubmitQcDate': '2023-08-13', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonographic Cartilage Thickness Measurement', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Tibial cartilage thickness will be visualized by ultrasound with the knee held in 30 degrees of flexion, and 3 measurements will be taken from the medial, lateral and midline.'}, {'measure': 'Ultrasonographic Muscle Measurement Thickness Measurement', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'The quadriceps muscle thickness will be measured by determining the midpoint between the SIAS and the patella while the patient is lying in the supine position. Hamstring muscle thickness will be measured at the intersection of a line drawn at 60% distal between the greater trochanter and the outer femoral condyle, and at the midline of the popliteal fossa, with the patient lying on the prone. These 2 measurements will be proportional to each other.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Knee Pain Chronic', 'Muscle Loss', 'Cartilage Degeneration']}, 'descriptionModule': {'briefSummary': 'The knee pain status of the patients who are followed in the rheumatology special branch of the Physical Medicine and Rehabilitation Outpatient Clinic and who meet the inclusion criteria will be questioned. In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest. The physician who performed the ultrasonographic measurements of the knee pain status of the patients does not know.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Rheumatoid Arthritis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid Arthritis \\> Diagnosed for 1 year\n* -Female gender\n* -The patient has been in remission or low disease activity for at least 3 months\n* -Be able to ambulatory\n* -No significant deformity in the lower extremity joints\n\nExclusion Criteria:\n\n* Patient with active arthritis or high disease activity\n\n * \\- Significant deformity of the lower extremity joints and inability to ambulate\n * -Pregnant patient\n * \\- Presence of malignancy\n * \\- Patient with a severe psychiatric disorder and difficulty in cooperation\n * \\- Presence of cardiovascular and pulmonary comorbidities that will prevent exercise\n * -Male gender'}, 'identificationModule': {'nctId': 'NCT05999266', 'briefTitle': 'The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'The Effect of Ultrasonographic Cartilage Thickness and Quadriceps/Hamstring Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '15082023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis Patients with Knee Pain', 'description': 'In patients with knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.', 'interventionNames': ['Diagnostic Test: Ultrasonographic Measurements']}, {'label': 'Rheumatoid Arthritis Patients without Knee Pain', 'description': 'In patients without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.', 'interventionNames': ['Diagnostic Test: Ultrasonographic Measurements']}], 'interventions': [{'name': 'Ultrasonographic Measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.', 'armGroupLabels': ['Rheumatoid Arthritis Patients with Knee Pain', 'Rheumatoid Arthritis Patients without Knee Pain']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Aylin Ayyıldız', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}