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出境医 / 临床实验 / Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready
Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cryotherapy Effect | Device: Game Ready® device Other: Wetted Ice Bag with Elastic Wrap | Not Applicable |
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:
- 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?
- Which cryotherapy method, Game Ready® or wetted ice with elastic wrap, will achieve an intramuscular tissue temperature reduction the fastest?
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Rate of Intramuscular Tissue Temperature Reduction Between Wetted Ice With Elastic Wrap and Game Ready |
| Actual Study Start Date : | September 27, 2019 |
| Actual Primary Completion Date : | October 15, 2019 |
| Actual Study Completion Date : | February 2, 2020 |
Arms and Interventions
| 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.
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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).
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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).
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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.
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Outcome Measures
Primary Outcome Measures :
- Intramuscular temperature [ Time Frame: The tissue temperatures will be recorded every 5 seconds and analyzed at the baseline. ]The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
- Intramuscular temperature [ Time Frame: The tissue temperatures will be recorded every 5 seconds and analyzed at 10 minutes. ]The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
- Intramuscular temperature [ Time Frame: The tissue temperatures will be recorded every 5 seconds and analyzed at 20 minutes. ]The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
- Intramuscular temperature [ Time Frame: The tissue temperatures will be recorded every 5 seconds and analyzed at 30 minutes/end time. ]The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations
Locations
| United States, North Dakota | |
| North Dakota State University | |
| Fargo, North Dakota, United States, 58108-6050 | |
Sponsors and Collaborators
North Dakota State University
Investigators
| Principal Investigator: | Kara Gange, PhD, ATC | Kara Gange |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 10, 2019 | ||||||
| First Posted Date ICMJE | July 15, 2019 | ||||||
| Last Update Posted Date | February 26, 2020 | ||||||
| Actual Study Start Date ICMJE | September 27, 2019 | ||||||
| Actual Primary Completion Date | October 15, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready | ||||||
| Official Title ICMJE | The Rate of Intramuscular Tissue Temperature Reduction Between Wetted Ice With Elastic Wrap and Game Ready | ||||||
| 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:
|
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: 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. Masking: None (Open Label)Primary Purpose: Prevention |
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| Condition ICMJE | Cryotherapy Effect | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
20 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | February 2, 2020 | ||||||
| Actual Primary Completion Date | October 15, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 40 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04019392 | ||||||
| Other Study ID Numbers ICMJE | HE20001 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Kara Gange, North Dakota State University | ||||||
| Study Sponsor ICMJE | North Dakota State University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | North Dakota State University | ||||||
| Verification Date | February 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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