ColdNCT04277494
The Acute Effect of Cold Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes
A study testing Clorethyl cold spray® (Vapocoolant spray) in people with Cold and Spray, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Vikocoolant spray, also known as cold spray; It is a form of cryotherapy (cold treatment) used in sports medicine, athletic training, sports competitions and rehabilitation environments. It has been demonstrated in the literature that local cold application may cause increased resistance to movement. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- What is being tested?
- Clorethyl cold spray® (Vapocoolant spray)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2020to 15 Mar 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer athletes between the ages of 18-25 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
- Having a history of lower limb pain and previous surgery
- A history of insensitivity to local heat or cold
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul
Nuray Alaca, PhD, +9005324251290, nuray.alaca@acibadem.edu.tr
Nuray Alaca, PhD
About this study
Vikocoolant spray, also known as cold spray; It is a form of cryotherapy (cold treatment) used in sports medicine, athletic training, sports competitions and rehabilitation environments. It has been demonstrated in the literature that local cold application may cause increased resistance to movement. It has been reported in some studies that muscle can change its mechanical properties in a short time. However, the effect of cold spray application on the mechanical properties of the muscle is unknown. Therefore, in the current study proposal, the investigators aim to investigate the acute effect of cold spray application on the mechanical properties of the quadriceps muscle in athletes.
Read the detailed description
Tissue cooling (cryotherapy treatment) is a long-standing pain therapy for the treatment of acute injuries and during rehabilitation. It is used in addition to other treatments . The main purpose of cryotherapy is to cool the tissue temperature and is used in the clinic in the form of various cryotherapy modalities such as whole body cryotherapy, cold spray, cryotherapy clamps, frozen peas, cold water immersion, ice and cold packs . The first physiological response of cooling is a decrease in tissue temperature . Studies have shown that local cold application causes increased resistance to movement . Although it has been reported in animal studies conducted in vitro that muscle tissue shows high resistance to stretching after cooling down , only one study evaluating direct mechanical responses to muscles in human studies There. 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 also stated that careful warm-up should be recommended after cooling to normalize the mechanical properties of the muscle and prevent injury .
Also known as cold spray, vikocoolant spray is a form of cryotherapy used in sports medicine, athletic training and rehabilitation environments and is widely used in the world . Especially in field medicine, it is frequently used as the first treatment of sports injuries. However, as is often done, returning to the game and competition with the help of the emerging analgesia is inconvenient in terms of the treatment of injury . However, it is still used frequently due to ease of application. The use of cold spray as a therapeutic method is of particular interest, as it is typically applied for a much shorter time than other cryotherapy modes . It has been shown in the literature that local cold application can cause increased resistance to movement and it is reported that it can change the mechanical properties of the muscle in a short time. However, the effect of cold spray application on the mechanical properties of the muscle is unknown. Therefore, in the current study proposal, the investigators aim to investigate the acute effect of cold spray application on the mechanical properties of the quadriceps muscle in athletes.
- Conditions
- Cold, Spray, Muscle, Athletic Injuries
- Being tested
- Clorethyl cold spray® (Vapocoolant spray)
- Keywords
- cold, spray, muscle, Athletic Injuries
- Medical subject headings
- Common Cold, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clorethyl cold spray® (Vapocoolant spray)Other
From the anterior superior of the dominant legs to the spinal iliac, the upper part of the patella will be measured and the center point will be marked. Cold spray will be applied to this point and its surroundings. The ethyl chloride spray bottle will be kept approximately 30 cm from the skin. An ethyl chloride stream will be applied at a 45 ° angle for 15 seconds (Shadgan et al., 2015). Skin temperature and mechanical properties of muscle; will be measured before, immediately after, 2 minutes, 5 minutes and 15 minutes after cold application.
| Study group | Role | What they receive |
|---|---|---|
| Clorethyl cold spray® (Vapocoolant spray) | Experimental | 23 volunteer athletes who are studying at the Faculty of Health Sciences of Acıbadem University, between the ages of 18-23, with a subcutaneous fold thickness of the quadriceps muscle between 5 mm and 15 mm (Shadgan et al., 2015).
From the anterior superior of the dominant legs to the spinal iliac, the upper part of the patella will be measured and the center point will be marked. Cold spray will be applied to this point and its surroundings. The ethyl chloride spray bottle will be kept approximately 30 cm from the skin. An ethyl chloride stream will be applied at a 45 ° angle for 15 seconds (Shadgan et al., 2015). Skin temperature and mechanical properties of muscle; will be measured before, immediately after, 2 minutes, 5 minutes and 15 minutes after cold application. Receives: Other: Clorethyl cold spray® (Vapocoolant spray) |
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 skin temperature at 0 minute, 2 minute, 15 minute post-spray
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 mechanical properties at 0 minute, 2 minute, 15 minute post-spray
Evaluation of the mechanical properties of the muscle-2
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Measured: Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray
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 mechanical properties at 0 minute, 2 minute, 15 minute post-spray
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 Jan 2020
- Primary completion15 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT04277494
- Sponsor's protocol ID
- 2019-17/20
- Status last verified
- Jan 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 Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes
- ClinicalTrials.gov ID
- NCT04277494
- Acronym / sponsor ID
- 2019-17/20
- Conditions
- Cold, Spray, Muscle, Athletic Injuries
- Keywords
- cold, spray, muscle, Athletic Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 15 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.
Vikocoolant spray, also known as cold spray; It is a form of cryotherapy (cold treatment) used in sports medicine, athletic training, sports competitions and rehabilitation environments. It has been demonstrated in the literature that local cold application may cause increased resistance to movement. It has been reported in some studies that muscle can change its mechanical properties in a short time. However, the effect of cold spray application on the mechanical properties of the muscle is unknown. Therefore, in the current study proposal, the investigators aim to investigate the acute effect of cold spray application on the mechanical properties of the quadriceps muscle in athletes.
Detailed description
Tissue cooling (cryotherapy treatment) is a long-standing pain therapy for the treatment of acute injuries and during rehabilitation. It is used in addition to other treatments . The main purpose of cryotherapy is to cool the tissue temperature and is used in the clinic in the form of various cryotherapy modalities such as whole body cryotherapy, cold spray, cryotherapy clamps, frozen peas, cold water immersion, ice and cold packs . The first physiological response of cooling is a decrease in tissue temperature . Studies have shown that local cold application causes increased resistance to movement . Although it has been reported in animal studies conducted in vitro that muscle tissue shows high resistance to stretching after cooling down , only one study evaluating direct mechanical responses to muscles in human studies There. 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 also stated that careful warm-up should be recommended after cooling to normalize the mechanical properties of the muscle and prevent injury .
Also known as cold spray, vikocoolant spray is a form of cryotherapy used in sports medicine, athletic training and rehabilitation environments and is widely used in the world . Especially in field medicine, it is frequently used as the first treatment of sports injuries. However, as is often done, returning to the game and competition with the help of the emerging analgesia is inconvenient in terms of the treatment of injury . However, it is still used frequently due to ease of application. The use of cold spray as a therapeutic method is of particular interest, as it is typically applied for a much shorter time than other cryotherapy modes . It has been shown in the literature that local cold application can cause increased resistance to movement and it is reported that it can change the mechanical properties of the muscle in a short time. However, the effect of cold spray application on the mechanical properties of the muscle is unknown. Therefore, in the current study proposal, the investigators aim to investigate the acute effect of cold spray application on the mechanical properties of the quadriceps muscle in athletes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clorethyl cold spray® (Vapocoolant spray) | Experimental | Other: Clorethyl cold spray® (Vapocoolant spray)23 volunteer athletes who are studying at the Faculty of Health Sciences of Acıbadem University, between the ages of 18-23, with a subcutaneous fold thickness of the quadriceps muscle between 5 mm and 15 mm (Shadgan et al., 2015). From the anterior superior of the dominant legs to the spinal iliac, the upper part of the patella will be measured and the center point will be marked. Cold spray will be applied to this point and its surroundings. The ethyl chloride spray bottle will be kept approximately 30 cm from the skin. An ethyl chloride stream will be applied at a 45 ° angle for 15 seconds (Shadgan et al., 2015). Skin temperature and mechanical properties of muscle; will be measured before, immediately after, 2 minutes, 5 minutes and 15 minutes after cold application. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteer athletes between the ages of 18-25 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
- Having a history of lower limb pain and previous surgery
- 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 |
|---|---|---|
| Clorethyl cold spray® (Vapocoolant spray)From the anterior superior of the dominant legs to the spinal iliac, the upper part of the patella will be measured and the center point will be marked. Cold spray will be applied to this point and its surroundings. The ethyl chloride spray bottle will be kept approximately 30 cm from the skin. An ethyl chloride stream will be applied at a 45 ° angle for 15 seconds (Shadgan et al., 2015). Skin temperature and mechanical properties of muscle; will be measured before, immediately after, 2 minutes, 5 minutes and 15 minutes after cold application. | Other | Clorethyl cold spray® (Vapocoolant spray) |
Primary outcome
Measurement of skin temperature
Time frame: Change from skin temperature at 0 minute, 2 minute, 15 minute post-spray
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 mechanical properties at 0 minute, 2 minute, 15 minute post-spray
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 mechanical properties at 0 minute, 2 minute, 15 minute post-spray
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 mechanical properties at 0 minute, 2 minute, 15 minute post-spray
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?
A study testing Clorethyl cold spray® (Vapocoolant spray) in people with Cold and Spray, 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 skin temperature at 0 minute, 2 minute, 15 minute post-spray). 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 NCT04277494, 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.