Cryotherapy EffectNCT04019392
Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready
A study testing Game Ready® device and Wetted Ice Bag with Elastic Wrap in people with Cryotherapy Effect, run by North Dakota State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Game Ready® device and Wetted Ice Bag with Elastic Wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 2 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University
Fargo, North Dakota, 58108-6050
About this study
Official title: 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.
Read the 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?
- Conditions
- Cryotherapy Effect
- Being tested
- Game Ready® device, Wetted Ice Bag with Elastic Wrap
- Keywords
- cooling rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Ready® deviceDevice
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 Bag with Elastic WrapOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Wetted Ice Bag with Elastic Wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramuscular temperature
The triceps surae intramuscular tissue temperature will be recorded with thermocouples inserted 2cm below the adipose.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The tissue temperatures will be recorded every 5 seconds and analyzed at 30 minutes/end time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start27 Sep 2019
- Primary completion15 Oct 2019
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Gange, North Dakota State University
- Investigators
- Kara Gange, PhD, ATC, Principal investigator, Kara Gange
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019392
- Sponsor's protocol ID
- HE20001
- Status last verified
- Feb 2020
- First submitted
- 10 Jul 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rate of Intramuscular Tissue Temperature Reduction Between Wetted Ice With Elastic Wrap and Game Ready
- ClinicalTrials.gov ID
- NCT04019392
- Acronym / sponsor ID
- HE20001
- Conditions
- Cryotherapy Effect
- Keywords
- cooling rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wetted ice with elastic wrap | Active comparator | Device: Game Ready® deviceA 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. |
| Game Ready | Active comparator | Other: Wetted Ice Bag with Elastic WrapThe 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Ready® deviceThe 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). | Device | Wetted ice with elastic wrap |
| Wetted Ice Bag with Elastic WrapA 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. | Other | Game Ready |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Gange, PhD, ATC principal investigator
Kara Gange
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Ready® device and Wetted Ice Bag with Elastic Wrap in people with Cryotherapy Effect, run by North Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intramuscular temperature (time frame: The tissue temperatures will be recorded every 5 seconds and analyzed at the baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.