Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-23 @ 7:13 AM
Study NCT ID:
NCT02235818
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2013-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2013-07-04', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain levels', 'timeFrame': 'initial visit', 'description': 'Pain levels were recorded with Numeric Pain Rating scale before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.'}], 'primaryOutcomes': [{'measure': 'Pain free grip strength', 'timeFrame': 'initial visit', 'description': 'Pain free grip strength was recorded with J-tech medical dynamometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.'}], 'secondaryOutcomes': [{'measure': 'Pressure Pain Threshold', 'timeFrame': 'initial visit', 'description': 'Pressure Pain Threshold was recorded with J-tech medical Algometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tennis elbow, treatment, lateral epicondylitis, immediate effects'], 'conditions': ['Tennis Elbow']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the immediate efficacy of Counterforce brace versus kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a repetitive physical task. The investigators hypothesized that there would be difference in the outcomes with respect to interventions and activity. Patient came for one hour long Single occasion testing session and were not followed up after the testing was complete.', 'detailedDescription': 'This was a cross over randomized control trial. Thirty patients with clinical diagnosis of lateral epicondylosis/tennis elbow were recruited from a local community and were tested on single occasion (one time testing session) before and after a five minute upper extremity repetitive task first with control and then brace and kinesiotape assigned in cross-over design. The testing session was one hour long and there was no follow up of patients following the testing. The patients were recruited between Jan-June 2013.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age (18-70 years)\n2. Ability to provide written informed consent to participate\n3. Were at least three weeks from onset of symptoms\n4. Complaints of discomfort or pain at the lateral elbow region for a minimum of three weeks and tenderness with palpation of the lateral epicondyle\n5. Provocation of lateral elbow pain with one of the following test - resisted middle finger extension, resisted wrist extension or passive stretch of wrist extensors\n\nExclusion Criteria:\n\n1. History of surgery on affected elbow\n2. History of cortisone injections on the affected elbow in the past 4 weeks\n3. Any physical or mental limitations that precluded performance of the study testing\n4. Allergy to adhesive tapes'}, 'identificationModule': {'nctId': 'NCT02235818', 'acronym': 'LE', 'briefTitle': 'Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Immediate Effectiveness of Counterforce Bracing Versus Kinesiotaping During Activity: A Randomized Crossover Trial in Patients With Lateral Epicondylosis', 'orgStudyIdInfo': {'id': 'HSREB103099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Kinesiotape (KT)', 'description': 'Kinesiotape was used only on the affected side as per the manufacturer instructions. With the elbow extended, wrist fully flexed and fingers pointed down 24, KT was applied with slight stretch (10-15%) and paper off tension to the lateral arm beginning just above the bony portion of lateral epicondyle. Once the top strand was anchored, KT was applied along the side of elbow such that hole in the tape was over lateral epicondyle of the elbow. Two strands of tape followed the lateral forearm and ended at around beginning of the distal one third of forearm. Once the support was applied, KT was gently rubbed to activate the glue.', 'interventionNames': ['Device: Kinesiotape']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Counterforce elbow brace', 'description': 'The counterforce brace was approximately 5cm wide with velcro attachment for adjustable girth. It had gel pack for extra support on extensor muscle mass. With the elbow extended, brace was applied 2.5cms below the lateral epicondyle. A feeling of comfortable compression, as reported by the patients was used to adjust the brace.', 'interventionNames': ['Device: Counterforce elbow brace']}], 'interventions': [{'name': 'Kinesiotape', 'type': 'DEVICE', 'otherNames': ['elastic tape, elastic therapeutic tape, kinesiotex tape'], 'description': 'Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm', 'armGroupLabels': ['Kinesiotape (KT)']}, {'name': 'Counterforce elbow brace', 'type': 'DEVICE', 'otherNames': ['elbow strap, forearm brace, forearm strap'], 'description': 'Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace', 'armGroupLabels': ['Counterforce elbow brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "The Hand and Upper Limb Centre, St. Joseph's Health Centre", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Joy C Macdermid, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}, {'name': 'Pritika Gogia, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director HULC Clinical Research lab', 'investigatorFullName': 'Joy MacDermid', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}