CClinicalTrials.gg
CompletedNCT06970366Updated Jun 6, 2025

Cryotherapy on Muscle Function

An interventional study of Cold pack application and Cold spray application in Cold, Cryotherapy and Cryotherapy Effect, sponsored by Okan University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Okan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Male
01

Study summary

On-field sports injuries are a common issue that significantly impacts athletes' performance and overall health. In team sports such as football, basketball, and volleyball, muscle and joint injuries are particularly frequent. Cryotherapy, including cold pack and cold spray applications, is widely used in the acute management of such injuries due to its practicality and rapid application. It is effective in reducing pain and edema by constricting blood vessels and slowing neural activity. While its analgesic effects are well-known, some studies suggest cryotherapy may also influence balance and proprioception. This study aims to investigate the acute effects of cryotherapy (cold pack and spray) on muscle mechanical properties, muscle strength, pain and EMG activity in healthy individuals.

A randomized, controlled experimental study will be conducted on healthy participants. Subjects will be divided into two groups: cold pack application and cold spray application. Quadriceps muscle mechanical properties will be assessed using a Myoton device; muscle strength will be evaluated via dynamometry, and muscle activity will be evaluated via electromyographic (EMG) device- NeuroTrac® MyoPlus 2. Each participant will be evaluated at four time points: baseline (pre-intervention), immediately after the intervention, 3 minutes post-intervention, and 5 minutes post-intervention. The effects of each modality will be compared both within and between groups to assess the short-term physiological changes induced by cryotherapy.

02

Conditions studied

  • Cold
  • Cryotherapy
  • Cryotherapy Effect
  • Muscle Activity
  • EMG

Keywords

  • cryotherapy
  • muscle activity
03

In context

Lead sponsor

Okan University is the lead sponsor of 96 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • being male
  • aging 18-25
  • having no history of cardiovascular or peripheral vascular disease, diabetes mellitus, neuromuscular pathology, peripheral neuropathy, lower extremity pain, or previous lower extremity surgery
  • being volunteer

Exclusion criteria

Exclusion Criteria:

  • having a history of insensitivity to local heat or cold
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Cold pack group

    Participants in this group will receive a standard cold pack application to the target muscle area while in a relaxed position. The cold pack, maintained at a temperature between 0-5°C, will be applied directly over the skin with a thin cloth barrier to prevent frostbite. The application will last for 10 minutes.

    Other: Cold pack application

  • Active comparator
    Cold spray group

    Participants in this group will receive a cold spray application to the target muscle area while in a relaxed position. A commercially available vapocoolant spray (e.g., ethyl chloride or similar) will be applied from a distance of approximately 20 cm in a sweeping motion for 5-10 seconds until the skin reaches a visible cooling effect without causing frostbite or discomfort.

    Other: Cold spray application

Interventions

  • OtherCold pack application

    Cold pack application

  • OtherCold spray application

    Cold spray application

06

What researchers measure

Primary outcomes

  1. Muscle Properties

    The assessment of muscle mechanical properties will be performed using the MyotonPRO device. Measurements will be taken bilaterally from the quadriceps muscle, specifically targeting the knee extensors.

    Time frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.

  2. Muscle strength

    The isometric muscle strength of the participants' dominant quadriceps muscle will be measured using a dynamometer. Muscle strength assessments will be performed with a calibrated Lafayette dynamometer (model 01163; Lafayette Instrument Company, Lafayette, IN, USA). Participants will receive verbal instructions about the procedure prior to testing. During the assessment, care will be taken to ensure that the device does not slip, that appropriate force is applied, that no compensatory movements occur in the tested extremity or other body parts, and that weakness is not masked by body positioning. For knee extensor evaluation, participants will be seated with their hands crossed over their shoulders, hips flexed at 90°, and knees locked at 60° of extension.

    Time frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.

  3. Muscle activity

    The EMG activity of the participants' dominant quadriceps muscle will be measured using a surface electromyography (EMG) device. For this assessment, the NeuroTrac® MyoPlus 2 dual-channel EMG ETS device (Verity Medical Ltd., UK) will be used. The device will be connected to a computer via dedicated software. To measure muscle activity, 32 mm diameter, circular, adhesive silver-silver chloride (Ag-AgCl) electrodes will be used. Three electrodes will be prepared individually for each participant. Prior to placement, the skin area where the surface electrodes will be attached will be cleaned with an alcohol wipe to reduce skin impedance. A reference electrode will be placed on the leg to eliminate external interference, while the active electrodes will be positioned directly over the target muscle.

    Time frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.

Secondary outcomes

  1. Pressure pain threshold

    The pressure pain threshold (PPT) of the dominant quadriceps muscle will be assessed using a digital pressure algometer. The algometer is equipped with a flat circular rubber-tipped probe (1 cm²) and will be applied perpendicularly to the skin over the quadriceps muscle belly. The probe will be pressed gradually at a constant rate (approximately 1 kg/cm² per second) until the participant reports the sensation of pressure turning into pain. The corresponding force value will be recorded as the PPT. Each participant will receive verbal instructions prior to the test, and the measurement site will be marked to ensure consistency across repeated measures. The assessment will be performed in a seated and relaxed position, with care taken to avoid muscle contraction or movement during the measurement.

    Time frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.

07

Study locations

1 site
  • Istanbul Okan University
    Istanbul, Tuzla 34000, Turkey
08

References and documents

Publications

  • Cryotherapy for acute musculoskeletal injuries: a systematic review and meta-analysis.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06970366
Lead sponsor
Okan University
Responsible party
Berna Cagla Balkisli (Assist. Prof., Okan University) — Principal investigator
First posted
May 14, 2025
Start date
May 15, 2025
Primary completion
May 31, 2025
Completion
Jun 2, 2025
Last update
Jun 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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