ColdNCT04277481
The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods
An observational study of Cold and Muscle Injury, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cold, Muscle Injury
- What is being tested?
- 10 minute cold pack, 12 minute cold pack and 15 minute cold pack
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2020to 15 Mar 2020
- Phase
- Observational
- 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 23 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem University
Istanbul, Ataşehir
Nuray Alaca, PhD, +9005324251290, nuray.alaca@acibadem.edu.tr
About this study
Official title: 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).
Read the 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).
- Conditions
- Cold, Muscle Injury
- Being tested
- 10 minute cold pack, 12 minute cold pack, 15 minute cold pack, 20 minute cold pack
- Keywords
- Cold pack, Muscle
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 minute cold packOther
10 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
12 minute cold packOther
12 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
15 minute cold packOther
15, min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
20 minute cold packOther
20 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 10 minute cold pack | |
| 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. Receives: Other: 12 minute cold pack | |
| 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. Receives: Other: 15 minute cold pack | |
| 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. Receives: Other: 20 minute cold pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of skin temperature
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.
Measured: 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
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Measured: Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
Evaluation of the mechanical properties of the muscle-2
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Measured: Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
Evaluation of the mechanical properties of the muscle-3
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Measured: Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start12 Feb 2020 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ColdStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277481
- Sponsor's protocol ID
- 2019-17/19
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11510876Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.
PubMed 12763442Bleakley 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.
PubMed 14754753Enwemeka 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.
PubMed 11782646Mustalampi 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.
PubMed 23068904
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods on the Mechanical Properties of the Quadriceps Muscle
- ClinicalTrials.gov ID
- NCT04277481
- Acronym / sponsor ID
- 2019-17/19
- Conditions
- Cold, Muscle Injury
- Keywords
- Cold pack, Muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 20 Feb 2020 (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.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (10 minute cold pack) | – | Other: 10 minute cold pack10 min, s 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) | – | Other: 12 minute cold pack12 min, s 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) | – | Other: 15 minute cold pack15 min, s 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) | – | Other: 20 minute cold pack20 min, s package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 10 minute cold pack10 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps. | Other | Group 1 (10 minute cold pack) |
| 12 minute cold pack12 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps. | Other | Group 2 (12 minute cold pack) |
| 15 minute cold pack15, min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps. | Other | Group 3 (15 minute cold pack) |
| 20 minute cold pack20 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps. | Other | Group 4 (20 minute cold pack) |
Primary outcome
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.
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 11510876Mac 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.
- Background: PubMed 12763442Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.
- Background: PubMed 14754753Bleakley 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.
- Background: PubMed 11782646Enwemeka 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.
- Background: PubMed 23068904Mustalampi 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cold and Muscle Injury, run by Acibadem University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of skin temperature (time frame: Change from Baseline skin temperature at 0 minute, 5 minute, 10 minute, 20 minute past- cold pack). 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?
On the ClinicalTrials.gov record for NCT04277481, which also lists 5 linked publications.
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 20 Feb 2020.