Cryotherapy Effect Clinical Trial
Official title:
The Rate of Intramuscular Tissue Temperature Reduction Between Wetted Ice With Elastic Wrap and Game Ready
Verified date | February 2020 |
Source | North Dakota State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2, 2020 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | North Dakota State University | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
North Dakota State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
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