Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 1:34 PM
Study NCT ID:
NCT05657535
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2022-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Knee Arthritis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No need of blinding'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Before and after of treatment in single group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-25', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale(VAS)', 'timeFrame': '4 weeks', 'description': 'Evaluation of pain on movement assessed by the VAS index'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '4 weeks', 'description': 'Evaluation of pain on movement assessed by the WOMAC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test low-intensity continuous ultrasound stimulator(LICUS) for patients suffering from knee arthritis. it aims to evaluate the pain relief effect of LICUS.\n\n35 participants were recruited, treated by LICUS on the knee joint for 5 minutes, 3 times a day for 4 weeks.\n\nThis study has single group and is for a before and after comparison of clinical treatment.', 'detailedDescription': 'Subject: 35 osteoarthritis patients Evaluation measure: Visual Analogue Scale (VAS), McMaster Universities Osteoarthritis Index (WOMAC) Method: A total of 35 subjects were selected in consideration of the dropout rate of 20%. Selected subjects were treated as a single group without randomization, and an appropriate amount of gel was applied to the knee OA pain area for 4 weeks. A blinded evaluation at baseline and after treat-ment was made. Primary outcome was pain on movement assessed by the VAS index. Secondary outcomes consisted of the WOMAC scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 40 to 60 years with pain due to OA of the knee and able to walk voluntarily\n* Those who have more than one osteophyte in the tibiofemoral joint on radiographic findings (Kellgren-Lawrence gradesⅡ,Ⅲ)\n* At visit 1 (screening) and visit 2, the pain status during knee OA activity was 100 mm pain VAS, as a result, those who are over 40mm\n* If the Kellgren \\& Lawrence Grades are the same, target the one with the higher 100mm pain VAS\n* Patients who are willing or able to follow the doctor's instructions, including joint movements\n* Persons who can comply with concomitantly permitted drugs, prohibited drugs, and relief drugs\n* Persons who can maintain the same exercise and activity during the clinical trial period\n* Fully understand the purpose and procedure of this clinical trial\n\nExclusion Criteria:\n\n* Those who have a history of rheumatoid arthritis or gouty arthritis or who have peripheral pain other than the knee joint patient.\n* Those with fractures or dislocations on simple radiological examination.\n* Those who are identified, or those with a similar risk of neuromuscular disease\n* Those who have participated in other clinical trials within 6 months of participating in clinical trials.\n* Patients with severe pain in the knee joint other than angular deformity, instability, and index knee in the knee joint\n* Patients with other tumors other than degenerative knee arthrosis\n* Persons with systemic symptoms that may affect knee pain\n* Pregnant and lactating women"}, 'identificationModule': {'nctId': 'NCT05657535', 'briefTitle': 'Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Knee Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial', 'orgStudyIdInfo': {'id': 'EMB-2022-7'}, 'secondaryIdInfos': [{'id': '2019-51-0458', 'type': 'OTHER_GRANT', 'domain': 'Mailtech Co.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment group', 'description': 'Single treatment group for evaluation pain relief before and after LICUS treatment', 'interventionNames': ['Device: Low-intensity continuous ultrasound stimulator']}], 'interventions': [{'name': 'Low-intensity continuous ultrasound stimulator', 'type': 'DEVICE', 'description': 'Stimulation 5 minutes, 3 times a day for 4 weeks on the knee', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Ganwon-do', 'country': 'South Korea', 'facility': 'Wonju College of Medicine', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Kyu-Jae Lee, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Convergence Medicine, Wonju College of Medicine, Yonsei University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyu Jae Lee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kyu Jae Lee', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}