KT Tape for Pediatric Clavicle Fractures

Not Applicable

Recruiting

• Conditions: Clavicle Fracture
• Interventions: Device: KT Tape; Device: Arm Sling

• Registration Number: NCT04161534
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

There 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-13
• Study Start: 2020-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clavicle Fracture
• Injury date within 1 week of presentation

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Exclusion Criteria

• Underlying neuromuscular disorder (eg osteogenesis imperfecta)
• Inability or unwillingness to report pain score until healing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KT Tape Group	KT Tape	-
Arm Sling Group	Arm Sling	-
KT Tape Group	Arm Sling	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Score	Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury	Participants will rate their pain on a scale from 1 to 10

Secondary Outcome Measures

Name	Time	Method
Change in Answers to DASH Questionnaire	Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.	Participants will complete the DASH questionnaire to assess disability they might be experiencing due to their fracture.
Change in Analgesic Use	Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury	Participants will provide the need for taking analgesics (name, dose, and frequency).

Trial Locations

Locations (1)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States