An interventional study of Game Ready® device and Wetted Ice Bag with Elastic Wrap in Cryotherapy Effect, sponsored by North Dakota State University. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by North Dakota State University · Not applicable, Interventional, and Prevention
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.
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:
North Dakota State University is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A standard ice bag filled with 2000 mL of cubed ice and 300 mL of 5˚C water will be applied to each participants' lower leg for 30 minutes using an elastic wrap. The elastic wrap will be applied at approximately 75% percent tension starting distal to the treatment area and moving proximally overlapping by half. The elastic wrap application will consist of pulling the wrap to its full tension, measuring the length of the wrap, and calculating 75% of the total length to apply to the body part.
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
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).
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.
Intramuscular temperature
The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
Time frame: The tissue temperatures will be recorded every 5 seconds and analyzed at the baseline.
Intramuscular temperature
The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
Time frame: The tissue temperatures will be recorded every 5 seconds and analyzed at 10 minutes.
Intramuscular temperature
The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
Time frame: The tissue temperatures will be recorded every 5 seconds and analyzed at 20 minutes.
Intramuscular temperature
The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
Time frame: The tissue temperatures will be recorded every 5 seconds and analyzed at 30 minutes/end time.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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North Dakota State University