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The Acute Effect of Cold Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes

Primary Purpose

Cold, Spray, Muscle

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clorethyl cold spray® (Vapocoolant spray)
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold focused on measuring cold, spray, muscle, Athletic Injuries

Eligibility Criteria

18 Years - 25 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Acibadem UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clorethyl cold spray® (Vapocoolant spray)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Evaluation of the mechanical properties of the muscle-1
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Evaluation of the mechanical properties of the muscle-2
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Evaluation of the mechanical properties of the muscle-3
Mechanical stiffness (N/m)will be measured in MyotonPro 3 (MYO, Tallin, Estonia).

Secondary Outcome Measures

Full Information

First Posted
February 7, 2020
Last Updated
February 18, 2020
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT04277494
Brief Title
The Acute Effect of Cold Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes
Official Title
The Acute Effect of Cold Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
February 15, 2020 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold, Spray, Muscle, Athletic Injuries
Keywords
cold, spray, muscle, Athletic Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clorethyl cold spray® (Vapocoolant spray)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clorethyl cold spray® (Vapocoolant spray)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of skin temperature
Description
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.
Time Frame
Change from skin temperature at 0 minute, 2 minute, 15 minute post-spray
Title
Evaluation of the mechanical properties of the muscle-1
Description
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Time Frame
Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray
Title
Evaluation of the mechanical properties of the muscle-2
Description
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Time Frame
Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray
Title
Evaluation of the mechanical properties of the muscle-3
Description
Mechanical stiffness (N/m)will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Time Frame
Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Acibadem University
City
İstanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuray Alaca, PhD
Phone
+9005324251290
Email
nuray.alaca@acibadem.edu.tr
First Name & Middle Initial & Last Name & Degree
Nuray Alaca, PhD
First Name & Middle Initial & Last Name & Degree
İhsan Alaca, pt
First Name & Middle Initial & Last Name & Degree
Mustafa Yüksel, prof

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11510876
Citation
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.
Results Reference
background
PubMed Identifier
12763442
Citation
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.
Results Reference
background
PubMed Identifier
14754753
Citation
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.
Results Reference
background
PubMed Identifier
11782646
Citation
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.
Results Reference
background
PubMed Identifier
23068904
Citation
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.
Results Reference
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The Acute Effect of Cold Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes

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