Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT04161534
Status:
RECRUITING
Last Update Posted:
2024-10-18
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KT Tape for Pediatric Clavicle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-11-11', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score', 'timeFrame': 'Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury', 'description': 'Participants will rate their pain on a scale from 1 to 10'}], 'secondaryOutcomes': [{'measure': 'Change in Answers to DASH Questionnaire', 'timeFrame': 'Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.', 'description': 'Participants will complete the DASH questionnaire to assess disability they might be experiencing due to their fracture.'}, {'measure': 'Change in Analgesic Use', 'timeFrame': 'Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury', 'description': 'Participants will provide the need for taking analgesics (name, dose, and frequency).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['arm sling', 'Kinesiology tape'], 'conditions': ['Clavicle Fracture']}, 'referencesModule': {'references': [{'pmid': '26530661', 'type': 'BACKGROUND', 'citation': 'Ersen A, Atalar AC, Birisik F, Saglam Y, Demirhan M. Comparison of simple arm sling and figure of eight clavicular bandage for midshaft clavicular fractures: a randomised controlled study. Bone Joint J. 2015 Nov;97-B(11):1562-5. doi: 10.1302/0301-620X.97B11.35588.'}, {'pmid': '30134883', 'type': 'BACKGROUND', 'citation': 'Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.'}, {'pmid': '20443039', 'type': 'BACKGROUND', 'citation': 'Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clin Rheumatol. 2011 Feb;30(2):201-7. doi: 10.1007/s10067-010-1475-6. Epub 2010 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling.\n\nThere have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clavicle Fracture\n* Injury date within 1 week of presentation\n\nExclusion Criteria:\n\n* Underlying neuromuscular disorder (eg osteogenesis imperfecta)\n* Inability or unwillingness to report pain score until healing'}, 'identificationModule': {'nctId': 'NCT04161534', 'briefTitle': 'KT Tape for Pediatric Clavicle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'KT Tape Vs Arm Sling for Pediatric Clavicle Fractures', 'orgStudyIdInfo': {'id': 'IRB-300004149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm Sling Group', 'interventionNames': ['Device: Arm Sling']}, {'type': 'EXPERIMENTAL', 'label': 'KT Tape Group', 'interventionNames': ['Device: KT Tape', 'Device: Arm Sling']}], 'interventions': [{'name': 'KT Tape', 'type': 'DEVICE', 'description': 'in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.', 'armGroupLabels': ['KT Tape Group']}, {'name': 'Arm Sling', 'type': 'DEVICE', 'description': 'An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.', 'armGroupLabels': ['Arm Sling Group', 'KT Tape Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Achraf Jardaly, BS', 'role': 'CONTACT', 'email': 'ajardaly@uab.edu', 'phone': '2056176680'}, {'name': 'Shawn R Gilbert, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Achraf H Jardaly, BS', 'role': 'CONTACT', 'email': 'ajardaly@uab.edu', 'phone': '2056176680'}, {'name': 'Alice Pennington, RN', 'role': 'CONTACT', 'email': 'alicep@uab.edu', 'phone': '2056389540'}], 'overallOfficials': [{'name': 'Shawn R Gilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief of Pediatric Orthopaedics', 'investigatorFullName': 'Shawn Gilbert', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}