Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready

NCT ID: NCT04019392

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-27
• Study Completion Date: 2020-02-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Game Ready® device

Intervention Type: 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).

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).

Group Type: ACTIVE_COMPARATOR

Wetted Ice Bag with Elastic Wrap

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Kara Gange

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kara Gange, PhD, ATC

Role: PRINCIPAL_INVESTIGATOR

Kara Gange

Locations

North Dakota State University

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

HE20001

Identifier Type: -

Identifier Source: org_study_id