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临床试验/NCT04161534
NCT04161534招募中不适用

KT Tape Vs Arm Sling for Pediatric Clavicle Fractures

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Change in Pain Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clavicle Fracture
  • Injury date within 1 week of presentation

排除标准

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

结局指标

主要结局

Change in Pain Score

时间窗: 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

次要结局

  • Change in Answers to DASH Questionnaire(Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.)
  • Change in Analgesic Use(Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn Gilbert

Professor, Chief of Pediatric Orthopaedics

University of Alabama at Birmingham

研究点 (2)

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