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

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.

Study Overview

• Status: Completed
• Conditions: Cryotherapy Effect
• Intervention / Treatment: Device: Game Ready® device; Other: Wetted Ice Bag with Elastic Wrap

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?

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58108-6050
      • North Dakota State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wetted ice with elastic wrap; 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).
Active Comparator: Game Ready; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: North Dakota State University
• Investigators: Principal Investigator: Kara Gange, PhD, ATC, Kara Gange

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): February 2, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cooling rates
• Other Study ID Numbers: HE20001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No