Cryotherapy EffectNCT06079437
The Effect of Brief Skin Cooling on Isometric Muscle Strength
A study testing Cheer and The cold pressure test in people with Cryotherapy Effect, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
There is sympathetic innervation of the muscular spindle. The application of cold to the skin provides an increase in sympathetic activity. In rehabilitation practice, short-term local cold is applied to the skin to provide motor facilitation. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Cheer and The cold pressure test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 22 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
Who cannot join
- Scar, dermatitis, etc. in the skin tissue where the surface electromyography electrode will be placed
- Upper extremity bone and joint disease, history of neuromuscular disease
- Heart disease, Hypertension
- Cold intolerance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
About this study
Official title: The Effect of Brief Skin Cooling on Isometric Muscle Strength and the Neuronal Mechanism Underlying This Effect
There is sympathetic innervation of the muscular spindle. The application of cold to the skin provides an increase in sympathetic activity. In rehabilitation practice, short-term local cold is applied to the skin to provide motor facilitation. The aim of this study was to examine whether short-term local cold application provides an increase in isometric contractile strength and, if so, whether this effect is related to muscle spindle activity.
Read the detailed description
Cold application is frequently used in sports medicine and rehabilitation due to its beneficial effects on the neuromuscular system. Its main beneficial effects are facilitating muscle contraction (motor facilitation), increasing isometric muscle force formation and reducing spasticity. The motor effects of cold application may vary depending on the application time, cooling agent (ice, ice water, cooling spray, etc.) and subcutaneous fatty tissue thickness. Short-term cold application can increase contraction force through motor facilitation. As the duration of cold application increases, the effects of cold that inhibit motor functions, such as gamma motor neuron inhibition, muscle spindle inhibition, and muscle conduction block, come to the fore. With this effect, it is used in the treatment of spasticity.
Neurophysiological studies to explain the motor effects of cold application have generally focused on the monosynaptic muscle spindle-based reflex. The monosynaptic muscle spindle-based reflex activates muscle spindles and stimulates alpha motor neurons via Group Ia afferent nerves. This effect is also known as the servo-motor (servo-assistance) effect of the muscle spindle. The increase in the sensitivity of the muscle spindle can provide motor facilitation by strengthening the servo-assistance effect.
It has been shown that the muscle spindle has sympathetic innervation. It has been shown that the cold stress test can be an alternative to the classical autonomic nerve test and can be used to test sympathetic system activation. Additionally, studies have shown that cold stress test, mental arithmetic, isometric contraction and muscle ischemia cause an increase in muscle spindle sensitivity through increased sympathetic activity.
A literature review has shown that there is no study examining the mechanism underlying the effect of local cold application on motor facilitation. Demonstrating the effect of local cold application on increasing maximum contraction force through muscle spindle sensitivity is also important for clinical applications to be more effective and efficient. The aim of this study was to examine whether short-term local cold application increases isometric contraction force and, if there is an increase, whether this effect is related to muscle spindle activity.
- Conditions
- Cryotherapy Effect
- Being tested
- Cheer, The cold pressure test
- Keywords
- soleus v-wave, sympathetic outflow, muscle spindle, cold stress test, sympathetic system, contractile force, motor facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CheerProcedure or surgery
Maximum isometric contraction was performed with cheering.
The cold pressure testProcedure or surgery
Maximum isometric contraction was performed with the cold pressure test.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Heart rate, maximum isometric muscle strength, Soleus H-reflex, M-wave, and V-wave measurements were taken in three consecutive periods. First-period maximal isometric contraction; second-period maximal isometric contraction + cold pressure test; third-period maximal isometric contraction + Cheering Receives: Procedure: Cheer; Procedure: The cold pressure test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate was monitored with DII derivation electrocardiographic recording. Heart rate was reported as beats per minute.
Measured: during procedure
Soleus H-reflex amplitude
By stimulating the tibial nerve with an electrical current, the Soleus H-reflex was obtained. Its peak to peak amplitude will be measured in microvolts.
Measured: during procedure
Soleus V-wave amplitude
Soleus V-wave was obtained by applying an electrical current to the tibial nerve during maximum voluntary contraction (MCV). Peak-to-peak amplitude was measured in microvolts.
Measured: during procedure
Maximum isometric muscle strength
Maximum isometric muscle strength of ankle plantar flexors was measured using a force sensor
Measured: during procedure
Secondary outcomes (1)
Skin temperature
The skin temperature of the back of the hand exposed to the cold application was measured with an infrared thermometer and the results were reported in degrees Celsius.
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 Apr 2023
- Primary completion20 Apr 2023
- Study completion22 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mert Cetin, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Mert Cetin, MD, Principal investigator, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079437
- Sponsor's protocol ID
- CISVWSA
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brief Skin Cooling on Isometric Muscle Strength and the Neuronal Mechanism Underlying This Effect
- ClinicalTrials.gov ID
- NCT06079437
- Acronym / sponsor ID
- CISVWSA
- Conditions
- Cryotherapy Effect
- Keywords
- soleus v-wave, sympathetic outflow, muscle spindle, cold stress test, sympathetic system, contractile force, motor facilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 22 Apr 2023 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is sympathetic innervation of the muscular spindle. The application of cold to the skin provides an increase in sympathetic activity. In rehabilitation practice, short-term local cold is applied to the skin to provide motor facilitation. The aim of this study was to examine whether short-term local cold application provides an increase in isometric contractile strength and, if so, whether this effect is related to muscle spindle activity.
Detailed description
Cold application is frequently used in sports medicine and rehabilitation due to its beneficial effects on the neuromuscular system. Its main beneficial effects are facilitating muscle contraction (motor facilitation), increasing isometric muscle force formation and reducing spasticity. The motor effects of cold application may vary depending on the application time, cooling agent (ice, ice water, cooling spray, etc.) and subcutaneous fatty tissue thickness. Short-term cold application can increase contraction force through motor facilitation. As the duration of cold application increases, the effects of cold that inhibit motor functions, such as gamma motor neuron inhibition, muscle spindle inhibition, and muscle conduction block, come to the fore. With this effect, it is used in the treatment of spasticity.
Neurophysiological studies to explain the motor effects of cold application have generally focused on the monosynaptic muscle spindle-based reflex. The monosynaptic muscle spindle-based reflex activates muscle spindles and stimulates alpha motor neurons via Group Ia afferent nerves. This effect is also known as the servo-motor (servo-assistance) effect of the muscle spindle. The increase in the sensitivity of the muscle spindle can provide motor facilitation by strengthening the servo-assistance effect.
It has been shown that the muscle spindle has sympathetic innervation. It has been shown that the cold stress test can be an alternative to the classical autonomic nerve test and can be used to test sympathetic system activation. Additionally, studies have shown that cold stress test, mental arithmetic, isometric contraction and muscle ischemia cause an increase in muscle spindle sensitivity through increased sympathetic activity.
A literature review has shown that there is no study examining the mechanism underlying the effect of local cold application on motor facilitation. Demonstrating the effect of local cold application on increasing maximum contraction force through muscle spindle sensitivity is also important for clinical applications to be more effective and efficient. The aim of this study was to examine whether short-term local cold application increases isometric contraction force and, if there is an increase, whether this effect is related to muscle spindle activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Cheer, Procedure: The cold pressure testHeart rate, maximum isometric muscle strength, Soleus H-reflex, M-wave, and V-wave measurements were taken in three consecutive periods. First-period maximal isometric contraction; second-period maximal isometric contraction + cold pressure test; third-period maximal isometric contraction + Cheering |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
Key exclusion criteria (4 listed)
- Scar, dermatitis, etc. in the skin tissue where the surface electromyography electrode will be placed
- Upper extremity bone and joint disease, history of neuromuscular disease
- Heart disease, Hypertension
- Cold intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CheerMaximum isometric contraction was performed with cheering. | Procedure or surgery | experimental group |
| The cold pressure testMaximum isometric contraction was performed with the cold pressure test. | Procedure or surgery | experimental group |
Primary outcome
Heart rate
Time frame: during procedure
Heart rate was monitored with DII derivation electrocardiographic recording. Heart rate was reported as beats per minute.
Soleus H-reflex amplitude
Time frame: during procedure
By stimulating the tibial nerve with an electrical current, the Soleus H-reflex was obtained. Its peak to peak amplitude will be measured in microvolts.
Soleus V-wave amplitude
Time frame: during procedure
Soleus V-wave was obtained by applying an electrical current to the tibial nerve during maximum voluntary contraction (MCV). Peak-to-peak amplitude was measured in microvolts.
Maximum isometric muscle strength
Time frame: during procedure
Maximum isometric muscle strength of ankle plantar flexors was measured using a force sensor
1 secondary outcome
Skin temperature
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mert Cetin, MD principal investigator
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheer and The cold pressure test in people with Cryotherapy Effect, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: during procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.