NCT04277481

Brief 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. 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).

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 7, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
16 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

February 1, 2020

Enrollment Period

16 days

First QC Date

February 7, 2020

Last Update Submit

February 18, 2020

Conditions

ColdMuscle Injury

Keywords

Cold packMuscle

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 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).

    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).

    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).

    Change from Baseline mechanical properties at 0 minute, 10 minute, 20 minute past- cold pack

Study Arms (4)

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.

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.

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.

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.

Other: 20 minute cold pack

Interventions

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.

Group 1 (10 minute cold pack)
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.

Group 2 (12 minute cold pack)
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.

Group 3 (15 minute cold pack)
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.

Group 4 (20 minute cold pack)

Eligibility Criteria

Age18 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Ataşehir, Turkey (Türkiye)

Location

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 Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 20, 2020

Study Start

February 12, 2020

Primary Completion

February 28, 2020

Study Completion

March 15, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

TU(1)