NCT04277494

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

February 20, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

February 7, 2020

Last Update Submit

February 18, 2020

Conditions

Keywords

coldspraymuscleAthletic Injuries

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Other: Clorethyl cold spray® (Vapocoolant spray)

Interventions

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.

Clorethyl cold spray® (Vapocoolant spray)

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 11510876BACKGROUND
  • Bizzini 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.

    PMID: 12763442BACKGROUND
  • 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.

    PMID: 14754753BACKGROUND
  • 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.

    PMID: 11782646BACKGROUND
  • 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.

    PMID: 23068904BACKGROUND

MeSH Terms

Conditions

Common ColdAthletic Injuries

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 20, 2020

Study Start

January 12, 2020

Primary Completion

February 15, 2020

Study Completion

March 15, 2020

Last Updated

February 20, 2020

Record last verified: 2020-01

Locations