Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-04-07 @ 12:00 PM
Study NCT ID:
NCT02367157
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Wrist Morning Stiffness', 'timeFrame': 'participants will be followed for the duration in minutes of the morning stiffness, an expected average of 45 minutes]'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wrist Morning Stiffness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how the applications of Kinesio Tape affect the morning stiffness in patients with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Rheumatoid Arthritis according to the criteria of the American Rheumatism Association with a minimum of 6 months evolution from diagnosis.\n* These subjects must have morning stiffness daily in the wrist joint of a member or bilateral at least a month.\n\nExclusion Criteria:\n\n* Subjects in postoperative affecting the mobility of joints to study phase.\n* Subjects with sensory deficits or other inflammatory arthropathies.\n* Subjects who are or come in a state of emergence of the hand or wrist joints during the investigation.\n* Subjects who change their usual treatment (medication or other therapies) two months before the study or during the study.\n* We exclude subjects who present some kind of allergy to Kinesio-Tape in which case it will be removed immediately.'}, 'identificationModule': {'nctId': 'NCT02367157', 'briefTitle': 'Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.', 'organization': {'class': 'OTHER', 'fullName': 'CEU San Pablo University'}, 'orgStudyIdInfo': {'id': 'CEU-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Kinesio taping', 'description': 'Epicondilar and epitroclear muscle Kinesio Taping with a Space Correction on the wrist according Kenzo Kase Method', 'interventionNames': ['Procedure: Kenzo Kase Method', 'Device: Kinesio Taping']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention: Control'}], 'interventions': [{'name': 'Kenzo Kase Method', 'type': 'PROCEDURE', 'armGroupLabels': ['Experimental: Kinesio taping']}, {'name': 'Kinesio Taping', 'type': 'DEVICE', 'armGroupLabels': ['Experimental: Kinesio taping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28668', 'city': 'Boadilla del Monte', 'state': 'Madrid', 'country': 'Spain', 'facility': 'San Pablo CEU University', 'geoPoint': {'lat': 40.405, 'lon': -3.87835}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CEU San Pablo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}