Cryotherapy on Muscle Function
Cryotherapy and Muscle Function: Assessing Injury Risk in Immediate Return-to-Play Scenarios
1 other identifier
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2025
CompletedJune 6, 2025
June 1, 2025
16 days
May 6, 2025
June 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
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.
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
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.
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
Secondary Outcomes (1)
Pressure pain threshold
from the application (baseline), immediately after the application, 3 minutes post-application, and to 5 minutes post-application.
Study Arms (2)
Cold pack group
EXPERIMENTALParticipants 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 spray group
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- having a history of insensitivity to local heat or cold
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
Study Sites (1)
Istanbul Okan University
Istanbul, tuzla, 34000, Turkey (Türkiye)
Related Publications (1)
Cryotherapy for acute musculoskeletal injuries: a systematic review and meta-analysis.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof.
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
May 15, 2025
Primary Completion
May 31, 2025
Study Completion
June 2, 2025
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share