Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready

Cryotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019392
• Other study ID #: HE20001
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: February 2, 2020

Study information

• Verified date: February 2020
• Source: North Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2, 2020
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Cryotherapy Effect

Intervention

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.

Locations

Country	Name	City	State
United States	North Dakota State University	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
North Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intramuscular temperature	The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.	The tissue temperatures will be recorded every 5 seconds and analyzed at the baseline.
Primary	Intramuscular temperature	The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.	The tissue temperatures will be recorded every 5 seconds and analyzed at 10 minutes.
Primary	Intramuscular temperature	The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.	The tissue temperatures will be recorded every 5 seconds and analyzed at 20 minutes.
Primary	Intramuscular temperature	The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.	The tissue temperatures will be recorded every 5 seconds and analyzed at 30 minutes/end time.