Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-03 @ 12:26 PM
Study NCT ID:
NCT01314820
Status:
COMPLETED
Last Update Posted:
2011-03-15
First Post:
2011-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Joint Effusion on Quadriceps Muscle
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': 'D000077330', 'term': 'Saline Solution'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-14', 'studyFirstSubmitDate': '2011-03-14', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the peak torque of the knee extensors', 'timeFrame': 'within 5 minutes after intervention', 'description': 'to evaluate the effect of effusion on the peak torque of the knee extensors'}], 'secondaryOutcomes': [{'measure': 'the root mean square values of the vastus medialis and vastus lateralis muscles', 'timeFrame': 'within 5 minutes after intervention', 'description': 'to evaluate the effect of effusion on the RMS of the vastus medialis (VM) and vastus lateralis (VL) muscles'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee', 'Osteoarthritis', 'Effusion.'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '3403614', 'type': 'BACKGROUND', 'citation': 'Fahrer H, Rentsch HU, Gerber NJ, Beyeler C, Hess CW, Grunig B. Knee effusion and reflex inhibition of the quadriceps. A bar to effective retraining. J Bone Joint Surg Br. 1988 Aug;70(4):635-8. doi: 10.1302/0301-620X.70B4.3403614.'}, {'pmid': '3664162', 'type': 'BACKGROUND', 'citation': 'Jones DW, Jones DA, Newham DJ. Chronic knee effusion and aspiration: the effect on quadriceps inhibition. Br J Rheumatol. 1987 Oct;26(5):370-4. doi: 10.1093/rheumatology/26.5.370.'}, {'pmid': '19116960', 'type': 'BACKGROUND', 'citation': 'Rice D, McNair PJ, Dalbeth N. Effects of cryotherapy on arthrogenic muscle inhibition using an experimental model of knee swelling. Arthritis Rheum. 2009 Jan 15;61(1):78-83. doi: 10.1002/art.24168.'}]}, 'descriptionModule': {'briefSummary': 'The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA).', 'detailedDescription': 'Several studies have shown that knee effusion influenced quadriceps muscle activity and induced quadriceps arthrogenic muscle inhibition in normal volunteers. However, the effect of joint effusion on the quadriceps of patients with OA is controversial,and few patients with OA have been included in studies of joint effusion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 years old or older with knee osteoarthritis\n* knee pain without joint effusion confirmed by ultrasonography\n\nExclusion Criteria:\n\n* the presence of knee joint effusion determined using US\n* a history of knee injury or surgery\n* a history of knee injection within 3 months\n* a history of inflammatory arthritis\n* taking anticoagulants\n* balance or gait disturbance\n* diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01314820', 'briefTitle': 'Effects of Joint Effusion on Quadriceps Muscle', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'KC09OISI0161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'normal saline injection', 'description': '20 cc normal saline injection into the knee joint', 'interventionNames': ['Other: normal saline injection']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham injection', 'description': 'knee injection without saline', 'interventionNames': ['Other: sham injection']}], 'interventions': [{'name': 'normal saline injection', 'type': 'OTHER', 'otherNames': ['normal saline'], 'description': '20 cc normal saline injection into knee joint', 'armGroupLabels': ['normal saline injection']}, {'name': 'sham injection', 'type': 'OTHER', 'otherNames': ['no normal saline'], 'description': 'no saline injection', 'armGroupLabels': ['sham injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': "Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jongin Lee, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': "Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': "Department of Rehabilitation Medicine, Seoul St. Mary's Hospital,", 'oldOrganization': 'College of Medicine, The Catholic University of Korea'}}}}