KT Tape for Pediatric Clavicle Fractures

Study Overview
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Brief Summary
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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.

Official Title
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KT Tape vs Arm Sling for Pediatric Clavicle Fractures

Conditions
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Clavicle Fracture

Intervention / Treatment
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* Device: KT Tape
* Device: Arm Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clavicle Fracture Injury date within 1 week of presentation Exclusion Criteria: Underlying neuromuscular disorder (eg osteogenesis imperfecta) Inability or unwillingness to report pain score until healing

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm Sling Group<br> | Device: Arm Sling<br>* An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.<br>|
| Experimental: KT Tape Group<br> | Device: KT Tape<br>* in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.<br>Device: Arm Sling<br>* An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arm sling, Kinesiology tape