- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06970366
- Original Trial
Cryotherapy on Muscle Function
Cryotherapy and Muscle Function: Assessing Injury Risk in Immediate Return-to-Play Scenarios
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tuzla
-
Istanbul, Tuzla, Turkey, 34000
- Istanbul Okan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- having a history of insensitivity to local heat or cold
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Cold spray application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Properties
Time Frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
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.
|
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
|
Muscle strength
Time Frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
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.
|
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
|
Muscle activity
Time Frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
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.
|
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain threshold
Time Frame: from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
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.
|
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cryotherapy for acute musculoskeletal injuries: a systematic review and meta-analysis.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OkanUNI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.