Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT02600702
Status:
COMPLETED
Last Update Posted:
2016-12-02
First Post:
2015-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee
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': '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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC score', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': '6 mins walk test', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Home base exercise'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1st osteoarthritis of the knee Age \\>/= 50 yrs\n\nExclusion Criteria:\n\n* Previous knee surgery for OA knee treatment\n* Has plan or schedule for knee surgery\n* Severe degree of OA knee.'}, 'identificationModule': {'nctId': 'NCT02600702', 'briefTitle': 'A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A Randomized Control Study of Siriraj Home Exercises Protocol for Primary Knee Osteoarthritis Patients Versus Usual Orthopedic Outpatient Consultation in Primary Knee Osteoarthritis Patients', 'orgStudyIdInfo': {'id': '444/2557(EC4)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'quadricep exercise'}, {'type': 'EXPERIMENTAL', 'label': 'Siriraj home base exercise', 'description': 'Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise', 'interventionNames': ['Other: Siriraj knee exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modalities and exercise', 'description': 'Physical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise', 'interventionNames': ['Other: Siriraj knee exercise', 'Other: Physical modalities']}], 'interventions': [{'name': 'Siriraj knee exercise', 'type': 'OTHER', 'description': 'Siriraj knee exercise, 12 position of exercise protocol', 'armGroupLabels': ['Modalities and exercise', 'Siriraj home base exercise']}, {'name': 'Physical modalities', 'type': 'OTHER', 'armGroupLabels': ['Modalities and exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}