Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-19 @ 6:15 AM
Study NCT ID:
NCT03727256
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}], 'ancestors': [{'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': '3 weeks', 'description': "Pain was assessed using a 0 to 10 visual analogue pain scale, with 0 meaning 'no pain' and 10 meaning 'excruciating pain'."}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': '3 weeks', 'description': 'The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters.To assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis, Minimum total score: 0, maximum total score: 96.Disability scores increase as Womac osteoarthritis index scores increase.'}, {'measure': '15 meter walking test', 'timeFrame': '3 weeks', 'description': 'The patients were asked to walk as fast as possible along a level, unobstructed corridor on the command "go." The patients stood before the starting line. A hand-held stopwatch was started as the subjects passed a predetermined start mark and stopped as they passed a second mark 15meter from the start mark.Walking duration was determined as second before and after treatment'}, {'measure': 'Muscle measurements were made before and after treatment.', 'timeFrame': '3 weeks', 'description': 'Ultrasonography was used to measure muscle thickness, pennation angle and fascicle length. Muscle thickness was measured as the mean distance between the superficial and deep aponeurosis at both image muscles. The distance between the intersection composed of the superficial aponeurosis and muscle fascicle, and the intersection composed of the deep aponeurosis and muscle fascicle was defined as muscle fascicle length. The results was measured as millimeter.The angle between the muscle fascicle and deep aponeurosis was defined as Pennation angle.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'neuromuscular electrical stimulation', 'ultrasound therapy'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To determine the effects of ultrasound therapy and neuromuscular electrical stimulation on the muscle architecture and functional capacity of patients with knee osteoarthritis.', 'detailedDescription': "All participants who were satisfied with the inclusion criteria were randomly assigned to one of two study groups: Group 1- ultrasound therapy group; Group 2 - the neuromuscular electrical stimulation group. Group allocation was randomized in two blocks of 30 sealed envelopes without external marks, which were mixed and numbered from 1 to 30, containing a piece of paper with the group allocation. The researchers responsible for outcome measures and ultrasonograhic measurements were blinded to the patients' diagnosis or intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n Clinical diagnosis of knee osteoarthritis\n2. Exclusion Criteria:\n\nCardiovascular diseases\n\nInflammatory diseases\n\nInfectious diseases\n\nLower extremity weakness\n\nTumoral diseases\n\nKnee surgery in the past six months\n\nIntra-articular injection in the past six months'}, 'identificationModule': {'nctId': 'NCT03727256', 'briefTitle': 'Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Recep Tayyip Erdogan University Medical School', 'orgStudyIdInfo': {'id': 'No sponsor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 patients', 'description': 'Patients have grade 2 or 3 knee osteoarthritis ultrasound therapy', 'interventionNames': ['Other: ultrasound therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 patients', 'description': 'Patients have grade 2 or 3 knee osteoarthritis neuromuscular electrical stimulation application', 'interventionNames': ['Other: neuromuscular electrical stimulation application']}], 'interventions': [{'name': 'ultrasound therapy', 'type': 'OTHER', 'description': 'Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes', 'armGroupLabels': ['Group 1 patients']}, {'name': 'neuromuscular electrical stimulation application', 'type': 'OTHER', 'description': 'Group 2, neuromuscular electrical stimulation application;20 mins/session', 'armGroupLabels': ['Group 2 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Gul Devrimsel', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'overallOfficials': [{'name': 'GUL DEVRIMSEL', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dr.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gul Devrimsel', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}