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临床试验/NCT04019392
NCT04019392已完成不适用

The Rate of Intramuscular Tissue Temperature Reduction Between Wetted Ice With Elastic Wrap and Game Ready

North Dakota State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Intramuscular temperature

研究概览

简要总结

This study compares the tissue temperature decrease between a wetted ice bag (ice and water) with an elastic wrap to the Game Ready® treatment. The goal is to determine which one decreases the temperature the most and the fastest, which is important in immediate care treatments of a musculoskeletal injury.

详细描述

The purpose of this study will be to determine which cryotherapy method, wetted ice bag and elastic wrap or Game Ready® set at medium pressure, decreases tissue temperature the most during a 30-minute treatment. Due to the convenience of Game Ready®, it is being used as an immediate care intervention. Findings in the literature have indicated wetted ice cools tissue temperature more than cubed or crushed ice based on the assumption that colder is better. Conversely, research on Game Ready® has revealed ice bags and slush buckets cause a greater reduction in tissue temperature compared to Game Ready®. However, no study exists comparing the effects of Game Ready® versus wetted ice on intramuscular tissue temperature reduction as immediate care interventions. Based on the results, this study may help contribute to the existing literature on tissue temperature reduction of both Game Ready® and wetted ice to determine the better modality to use for immediate care. The research questions guiding this study will be:

  1. Which cryotherapy method, Game Ready® or wetted ice with elastic wrap, will be the most effective at decreasing intramuscular tissue temperature during a 30-minute application in patients aged 18-40 years old?
  2. Which cryotherapy method, Game Ready® or wetted ice with elastic wrap, will achieve an intramuscular tissue temperature reduction the fastest?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be both male and female.
  • Subjects will be between 18 and 40 years of age.
  • Subjects will have no prior injury to the dominant lower leg within the past 6 months.
  • Subjects will be able to speak English.
  • Subjects will have less than 1 cm of adipose over the medial gastrocnemius muscle.

排除标准

  • any current lower extremity injury, or any lower extremity injuries within the past 6 months.
  • any previous history of surgery in the lower leg
  • any contraindications to cryotherapy such as Raynaud's phenomenon, cold-induced urticaria, previous frostbite to the lower leg, open wounds, peripheral vascular disease, lupus, circulatory insufficiency, mayocardial ischemia, or skin infections.
  • any abnormalities seen in the muscle as determined by diagnostic ultrasound.
  • any allergies or sensitivities to Betadine.
  • greater than 1.0cm of adipose over the medial gastrocnemius muscle (calf).

结局指标

主要结局

Intramuscular temperature

时间窗: The tissue temperatures will be recorded every 5 seconds and analyzed at 30 minutes/end time.

The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.

次要结局

未报告次要终点

研究者

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

Kara Gange

Associate Professor

North Dakota State University

研究点 (2)

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