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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04277494
Other study ID # 2019-17/20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 12, 2020
Est. completion date March 15, 2020

Study information

Verified date January 2020
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 23
Est. completion date March 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Turkey Acibadem University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. Review. — View 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. — View Citation

Mac Auley DC. Ice therapy: how good is the evidence? Int J Sports Med. 2001 Jul;22(5):379-84. Review. — View Citation

Mustalampi S, Ylinen J, Kautiainen H, Weir A, Häkkinen 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from skin temperature at 0 minute, 2 minute, 15 minute post-spray
Primary Evaluation of the mechanical properties of the muscle-1 Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia). Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray
Primary Evaluation of the mechanical properties of the muscle-2 Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia). Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray
Primary Evaluation of the mechanical properties of the muscle-3 Mechanical stiffness (N/m)will be measured in MyotonPro 3 (MYO, Tallin, Estonia). Change from mechanical properties at 0 minute, 2 minute, 15 minute post-spray
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