NCT04019392

Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: North Dakota State University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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?

Conditions

• Cryotherapy Effect

Interventions

Type	Name	Description
DEVICE	Game Ready® device	The half leg boot sleeve of the Game Ready® device (CoolSystems, Inc., Alamda, CA) will be applied to each participants' lower leg and ankle for 30 minutes set on the medium pressure setting (5-50 mmHG).
OTHER	Wetted Ice Bag with Elastic Wrap	A standard ice bag filled with 2000 mL of cubed ice and 300 mL of 5˚C water will be applied using an elastic wrap to each participants' lower leg for 30 minutes. An elastic wrap applied at approximately 75% percent tension starting distal to the treatment area and moving proximally overlapping by half will be applied over the wetted ice bag.

Timeline

• Start date: 2019-09-27
• Primary completion: 2019-10-15
• Completion: 2020-02-02
• First posted: 2019-07-15
• Last updated: 2020-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study