Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready

NCT04019392 | Completed FDA Device

• 1 other identifier: HE20001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect

Keywords

cooling rates

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

Wetted ice with elastic wrap

ACTIVE COMPARATOR

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

Game Ready

ACTIVE COMPARATOR

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

Interventions

Game Ready® device 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).

Wetted ice with elastic wrap

Wetted Ice Bag with Elastic Wrap 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.

Game Ready

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• North Dakota State University: lead

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58108-6050, United States

Location

Study Officials

• Kara Gange, PhD, ATC

  Kara Gange

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A 2 x 4 repeated measures design to determine decreases in triceps surae intramuscular tissue temperature will be used for this study. The independent variables will be the cryotherapy modalities (Game Ready® and wetted ice bag with elastic wrap) and time (baseline, 10 minutes, 20 minutes, and 30 minutes). The dependent variable will be the medial triceps surae intramuscular tissue temperature.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: September 27, 2019
• Primary Completion: October 15, 2019
• Study Completion: February 2, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)