Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
Study NCT ID:
NCT06542692
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2024-07-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scala', 'timeFrame': '3 weeks', 'description': 'Scale ranging from 0 to 10 points, where 0 points indicate no pain and 10 points indicate maximum pain.'}, {'measure': 'Womac', 'timeFrame': '3 weeks', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index'}, {'measure': 'muscle strength', 'timeFrame': '3 weeks', 'description': 'isometric muscle strength measurement(knee extension, flexion)'}, {'measure': 'Biodex', 'timeFrame': '3 weeks', 'description': 'Balance test'}, {'measure': 'Short Form 36', 'timeFrame': '3 weeks', 'description': 'A test consisting of 36 questions to assess quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vibration', 'whole body vibration', 'Osteoarthritis', 'Osteoarthritis, Knee'], 'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who were diagnosed with primary symptomatic knee OA according to ACR criteria,Ages between 35 and 70, Body mass index (BMI) ⩽35, Grade II or III according to Kellgren \\& Lawrence scale, Patients with persistent symptoms such as pain and stiffness for at least 3 months were included.\n\nExclusion Criteria:\n\n* Those who have had knee surgery before, Those with central nervous system disease (especially epilepsy and serious psychotic disorders), those with a history of acute arthritis, Those with a history of DVT in the last 24 weeks, Those with advanced lung or heart disease (COPD and heart failure), Those diagnosed with inflammatory rheumatic diseases (Rheumatoid arthritis, Spondyloarthropathy, etc.), Patients diagnosed with advanced stage cancer were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06542692', 'briefTitle': 'Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'E68869993-511.06.01.01-1193507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'Whole body vibration therapy added group', 'interventionNames': ['Device: Whole Body Vibration', 'Device: physical therapy modalities']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'interventionNames': ['Device: physical therapy modalities']}], 'interventions': [{'name': 'Whole Body Vibration', 'type': 'DEVICE', 'otherNames': ['physical therapy modalities'], 'description': 'treatment duration, frequency', 'armGroupLabels': ['study group']}, {'name': 'physical therapy modalities', 'type': 'DEVICE', 'description': 'ultrasound, hot pack, tens', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burak Çetinkaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Burak Çetinkaya', 'investigatorAffiliation': 'Kocaeli University'}}}}