Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 4:15 PM
Study NCT ID:
NCT05731869
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle activation', 'timeFrame': 'one hour', 'description': 'A superficial EMG system will be used to measure signals from the extensor carpi radialis longus/brevis and extensor carpi digitorum communis muscles.Electrodes will be placed according to SENIAM criteria.The signals received from the muscles of the individuals will be recorded during grasping. As a result, the average muscle activations of the muscles during the activity will be numerically recorded in %MVIC.'}], 'secondaryOutcomes': [{'measure': 'hand function', 'timeFrame': 'one hour', 'description': 'Jebson Taylor Hand Function Test, which includes daily life activities (writing, eating, etc.) and consists of 7 sub-parameters, was applied to measure hand function. The score is recorded in seconds and the score gets worse as the second increases.'}, {'measure': 'satisfaction level', 'timeFrame': 'one hour', 'description': "The OPUS questionnaire was used to measure the participants' orthotic satisfaction. The OPUS questionnaire evaluates the weight, durability, aesthetics, ease of putting on, skin and clothing problems, comfort, and the pain-reducing effect of the orthosis associated with the orthosis. The higher the score, the higher the level of satisfaction."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surface electromyography', 'muscle activation', 'orthosis'], 'conditions': ['Splints']}, 'referencesModule': {'references': [{'pmid': '38517366', 'type': 'DERIVED', 'citation': 'Sari M, Ozturk D, Bek N. Comparison of two different orthoses used in the treatment of lateral epicondylitis. Prosthet Orthot Int. 2025 Feb 1;49(1):127-132. doi: 10.1097/PXR.0000000000000345. Epub 2024 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is seen as lateral epicondylitis in the clinic. Physiotherapy techniques are frequently applied in the management of diseases related to forearm extensor muscles such as lateral epicondylitis. Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic extensor brace are used for this. Studies have been conducted on pain, hand function and orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of studies investigating the effects on muscle activation is insufficient.Therefore, the aim of the study is to examine the effects of different types of orthoses used for the forearm extensor group on extensor muscle activation and upper limb functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-45 years old\n* Right upper extremity dominant\n* No upper extremity limitation in activities of daily living\n* Volunteer individuals\n\nExclusion Criteria:\n\n* With orthopedic, neurological and rheumatological problems in the upper extremity\n* Entrapment neuropathy, TOS, cervical radiculopathy, and cervical disc herniation\n* History of upper extremity injury or surgery in the last 6 months'}, 'identificationModule': {'nctId': 'NCT05731869', 'briefTitle': 'Investigation of the Effect of Epicondylitis Band and Wrist Orthosis', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Investigation of the Effect of Epicondylitis Band and Wrist Orthosis on Extensor Muscle Activity and Upper Extremity Functions', 'orgStudyIdInfo': {'id': '2021/058'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'The group measured without the use of orthoses and tapes'}, {'label': 'Epicondylitis Band Group', 'description': 'Group measured with epicondylitis band', 'interventionNames': ['Other: epicondylitis band']}, {'label': 'Wrist Orthosis Group', 'description': 'Group measured with wrist orthosis', 'interventionNames': ['Other: wrist orhosis']}], 'interventions': [{'name': 'epicondylitis band', 'type': 'OTHER', 'description': 'An off-the-shelf lateral epicondylitis tape in S-M-L dimensions was used distal to the lateral epicondylitis.', 'armGroupLabels': ['Epicondylitis Band Group']}, {'name': 'wrist orhosis', 'type': 'OTHER', 'description': 'Wrist orthosis of the shelf was used in sizes S-M-L, covering the hand and wrist.', 'armGroupLabels': ['Wrist Orthosis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'Çankaya', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa Sarı', 'geoPoint': {'lat': 39.9179, 'lon': 32.86268}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}