The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods

February 18, 2020 updated by: Acibadem University

The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods on the Mechanical Properties of the Quadriceps Muscle

The cold pack application, which is a special silicate gel impregnated with water in a soft rubber envelope, is frequently applied in the clinic. It has been shown in the literature that local cold application causes increased resistance to movement. It is also reported that the muscle can change its mechanical properties in a short time. However, the effect of the cooling package application applied in different periods on the mechanical properties of the muscle is unknown. Therefore, 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 cold pack therapy applied on healthy individuals for different periods (10-12-15-20 minutes).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • Istanbul, Ataşehir, Turkey
        • Acibadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 23 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Volunteer student between the ages of 18-23 with a subcutaneous fold thickness of the quadriceps muscle between 5 mm and 15 mm.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 10 minute cold pack
10 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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.
Other: 12 minute cold pack
12 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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.
Other: 15 minute cold pack
15, min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
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.
Other: 20 minute cold pack
20 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
Change from Baseline skin temperature at 0 minute, 5 minute, 10 minute, 20 minute past- cold pack
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
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
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
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-17/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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