- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277481
The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods
The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods on the Mechanical Properties of the Quadriceps Muscle
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cold Packs (Cold Pack, CP); Slika gel packs are the most commonly used modalities in clinics. Special silicate gel impregnated with water in a soft rubber envelope is stored in coolers whose temperature is maintained between -12.2 ° C and 9.4 ° C . There are different sizes and shapes. Since it does not lose its softness when it is cooled, it adapts well to the folds of the body. By putting a towel between the skin and the package, a homogeneous cooling is tried to be achieved, hygiene is provided and it is easier to tolerate the feeling of extreme cold felt in the first contact of the cold package. It can be applied for a relatively long time without losing its cold due to its low conductivity. Significant increase in package temperature is seen from the 15th minute of the application. It is stated that it decreases the skin temperature up to 10 ° C and keeps it at 20 ° C-30 ° C for 3 hours depending on the room temperature. They can be used repeatedly by cooling .
Intensive cold application for 12-15 minutes is enough to reduce pain and muscle spasm . It has also been shown that a cold application over 30 minutes can cause cold bite and nerve problems . However, in practical applications, cold appears to vary between 15-30 minutes for pain, muscle spasm and edema . In a review made by Auley regarding cryotherapy treatments; ice application has been shown to be used in 5 to 85 minutes in many studies. They said that cold application does not have a specified frequency and duration, but repeated 10 minutes of cold application is effective. In addition, it has been reported that there is evidence of a slightly less drop from 10 minutes to 20 minutes while the temperature drops in the first 10 minutes .
In animal studies performed in vitro, although muscle tissue has reported high resistance to strain after cooling, direct mechanical responses to muscles in human studies There is only one study that evaluates. In this study carried out by Mustalampi et al., Parameter measurements indicating the mechanical properties of the muscle immediately after applying the cold pack applied locally to the quadriceps muscle for 20 minutes and after 15 minutes. As a result of the study, the muscle has become stiffer, less elastic in terms of mechanical properties and it has been shown that these changes do not completely recover after 15 minutes. It was not observed when it was reinstated after fifteen minutes.
In the light of this information, in the current study proposal; the investigators aim to investigate the acute effect (0 min, 5 min, 10 min, 15 min, 20 min and 30 min) of the cold pack therapy on the mechanical properties of the quadriceps muscle in healthy people for different periods (10-12-15-20 minutes).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey
- Acibadem University
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Contact:
- Nuray Alaca, PhD
- Phone Number: +9005324251290
- Email: nuray.alaca@acibadem.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteer student between the ages of 18-23 with a subcutaneous fold thickness of the quadriceps muscle between 5 mm and 15 mm.
- Non-smoker
- No drug use
Exclusion Criteria:
Having any cardiovascular or peripheral vascular disease
- Known neuromuscular pathology history
- Having diabetes mellitus disease
- Having a history of lower limb pain and previous surgery
- Has a history of insensitivity to local heat or cold
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1 (10 minute cold pack)
10 min, s package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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10 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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Group 2 (12 minute cold pack)
12 min, s package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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12 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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Group 3 (15 minute cold pack)
15 min, s package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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15, min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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Group 4 (20 minute cold pack)
20 min, s package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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20 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of skin temperature
Time Frame: Change from Baseline skin temperature at 0 minute, 5 minute, 10 minute, 20 minute past- cold pack
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For thermal imaging, a 120-9-90 pixel resolution FLIR E5 camera thermal camera (FLIR Systems AB, Sweden) will be used, and Color Palette iron will be selected to display images.
The video will be taken from a distance of 1 m at a speed of 8 photos / s.
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Change from Baseline skin temperature at 0 minute, 5 minute, 10 minute, 20 minute past- cold pack
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Evaluation of the mechanical properties of the muscle-1
Time Frame: Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
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Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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Evaluation of the mechanical properties of the muscle-2
Time Frame: Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
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Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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Evaluation of the mechanical properties of the muscle-3
Time Frame: Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
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Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol, Avon). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.
- Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.
- Mac Auley DC. Ice therapy: how good is the evidence? Int J Sports Med. 2001 Jul;22(5):379-84. doi: 10.1055/s-2001-15656.
- Enwemeka CS, Allen C, Avila P, Bina J, Konrade J, Munns S. Soft tissue thermodynamics before, during, and after cold pack therapy. Med Sci Sports Exerc. 2002 Jan;34(1):45-50. doi: 10.1097/00005768-200201000-00008.
- Mustalampi S, Ylinen J, Kautiainen H, Weir A, Hakkinen A. Acute effects of cold pack on mechanical properties of the quadriceps muscle in healthy subjects. Phys Ther Sport. 2012 Nov;13(4):265-9. doi: 10.1016/j.ptsp.2012.02.001. Epub 2012 Apr 23.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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