Cryotherapy EffectNCT05832970
Cooling Induces Motor Facilitation With Sympathetic Activation
A study testing Brief skin cooling in people with Cryotherapy Effect, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cryotherapy has beneficial effects such as motor facilitation, increase isometric force generation, and reduce spasticity. It is known that the muscle spindle has sympathetic innervation. Muscle spindle sensitivity increase with sympathetic activity. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Brief skin cooling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2023to 8 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
- Men only
- 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 superficial 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: Brief Skin Cooling Induces Muscle Spindle Sensitivity With Heightened Sympathetic Outflow
Cryotherapy has beneficial effects such as motor facilitation, increase isometric force generation, and reduce spasticity.
It is known that the muscle spindle has sympathetic innervation. Muscle spindle sensitivity increase with sympathetic activity. This research has three hypotheses: First, short-term cold application to the skin increases sympathetic activity. Second, there is an increase in muscle spindle sensitivity with increased sympathetic activity. Third, the effect of short-term cold on muscle spindle sensitivity continues until the skin temperature returns to normal. The purpose of this research is to test these hypotheses.
Read the detailed description
Cryotherapy is a frequently used treatment method in sports medicine and rehabilitation due to its beneficial neuromuscular effects. Its main beneficial effects are motor facilitation, increase isometric force generation, and reduce spasticity. The motor effects of cryotherapy may differ depending on the duration of application, the coolant used agent (ice, ice water, coolant spray, etc.), and the thickness of the subcutaneous adipose tissue. The short-term cold application increases the force of contraction with motor facilitation. As the cold application period gets longer, the effects of the cold that inhibit motor functions such as gamma motor neuron inhibition, muscle spindle inhibition, and muscle conduction block come to the fore.
It is known that the muscle spindle has sympathetic innervation. It has been reported in recent studies that mental arithmetic, cold application to the skin, isometric contraction of remote muscles, and ischemia increase muscle spindle sensitivity through increased sympathetic activity. However, there are very limited studies showing that cold application increases muscle spindle sensitivity through increased sympathetic activity. On the other hand, in terms of determining treatment and rehabilitation strategies, it is important to know how long the effect of the cold application on muscle spindle sensitivity continues. However, it is not clear how long the effect of the cold application on muscle spindle sensitivity lasts after the cold application ends. There is a widespread belief that the motor facilitation effect of cryotherapy can occur with the stimulation of cutaneous cold receptors. Considering this view, it can be thought that the effect of the short-term cold application on muscle spindle sensitivity continues until the skin temperature returns to normal. This research has three hypotheses: First, short-term cold application to the skin increases sympathetic activity. Second, there is an increase in muscle spindle sensitivity with increased sympathetic activity. Third, the effect of short-term cold on muscle spindle sensitivity continues until the skin temperature returns to normal. The purpose of this research is to test these hypotheses.
- Conditions
- Cryotherapy Effect
- Being tested
- Brief skin cooling
- Keywords
- muscle spindle, sympathetic outflow, motor facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief skin coolingOther
Brief skin cooling will be applied to the hand using the cold-bath immersion
| Study group | Role | What they receive |
|---|---|---|
| Hand cooling | Experimental | Records will be taken for Baseline electromyography, Heart rate, H-reflex, and T-reflex measurements before, during, and at 0, 3, 6, 9, 12, and 15. minutes before applying 2-4 degrees Celsius cold to the back of the hand in this group. Receives: Other: Brief skin cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Heart rate
Heart rate will be monitored with DII derivation electrocardiographic recording.Heart rate will be reported as beats per minute.
Measured: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Change from baseline in Soleus H-reflex
By stimulating the tibial nerve with an electrical current, the Soleus H-reflex will be obtained. Its peak to peak amplitude will be measured in microvolts.
Measured: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Change from baseline in T-reflex
Soleus T-reflex will be obtained by hitting the Achilles tendon with the electronic reflex hammer. Its peak to peak amplitude will be measured in microvolts.
Measured: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Secondary outcomes (1)
Skin temperature
The skin temperature of the back of the hand exposed to the cold application will be measured with an infrared thermometer and the results will be reported in degrees Celsius.
Measured: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start3 Apr 2023
- Primary completion7 Apr 2023
- Study completion8 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan KARACAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Prof, Principal investigator, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832970
- Sponsor's protocol ID
- CIMFSA
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 27 Apr 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Skin Cooling Induces Muscle Spindle Sensitivity With Heightened Sympathetic Outflow
- ClinicalTrials.gov ID
- NCT05832970
- Acronym / sponsor ID
- CIMFSA
- Conditions
- Cryotherapy Effect
- Keywords
- muscle spindle, sympathetic outflow, motor facilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 27 Apr 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.
Cryotherapy has beneficial effects such as motor facilitation, increase isometric force generation, and reduce spasticity.
It is known that the muscle spindle has sympathetic innervation. Muscle spindle sensitivity increase with sympathetic activity. This research has three hypotheses: First, short-term cold application to the skin increases sympathetic activity. Second, there is an increase in muscle spindle sensitivity with increased sympathetic activity. Third, the effect of short-term cold on muscle spindle sensitivity continues until the skin temperature returns to normal. The purpose of this research is to test these hypotheses.
Detailed description
Cryotherapy is a frequently used treatment method in sports medicine and rehabilitation due to its beneficial neuromuscular effects. Its main beneficial effects are motor facilitation, increase isometric force generation, and reduce spasticity. The motor effects of cryotherapy may differ depending on the duration of application, the coolant used agent (ice, ice water, coolant spray, etc.), and the thickness of the subcutaneous adipose tissue. The short-term cold application increases the force of contraction with motor facilitation. As the cold application period gets longer, the effects of the cold that inhibit motor functions such as gamma motor neuron inhibition, muscle spindle inhibition, and muscle conduction block come to the fore.
It is known that the muscle spindle has sympathetic innervation. It has been reported in recent studies that mental arithmetic, cold application to the skin, isometric contraction of remote muscles, and ischemia increase muscle spindle sensitivity through increased sympathetic activity. However, there are very limited studies showing that cold application increases muscle spindle sensitivity through increased sympathetic activity. On the other hand, in terms of determining treatment and rehabilitation strategies, it is important to know how long the effect of the cold application on muscle spindle sensitivity continues. However, it is not clear how long the effect of the cold application on muscle spindle sensitivity lasts after the cold application ends. There is a widespread belief that the motor facilitation effect of cryotherapy can occur with the stimulation of cutaneous cold receptors. Considering this view, it can be thought that the effect of the short-term cold application on muscle spindle sensitivity continues until the skin temperature returns to normal. This research has three hypotheses: First, short-term cold application to the skin increases sympathetic activity. Second, there is an increase in muscle spindle sensitivity with increased sympathetic activity. Third, the effect of short-term cold on muscle spindle sensitivity continues until the skin temperature returns to normal. The purpose of this research is to test these hypotheses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand cooling | Experimental | Other: Brief skin coolingRecords will be taken for Baseline electromyography, Heart rate, H-reflex, and T-reflex measurements before, during, and at 0, 3, 6, 9, 12, and 15. minutes before applying 2-4 degrees Celsius cold to the back of the hand in this group. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- 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 superficial 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 |
|---|---|---|
| Brief skin coolingBrief skin cooling will be applied to the hand using the cold-bath immersion | Other | Hand cooling |
Primary outcome
Change from baseline in Heart rate
Time frame: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Heart rate will be monitored with DII derivation electrocardiographic recording.Heart rate will be reported as beats per minute.
Change from baseline in Soleus H-reflex
Time frame: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
By stimulating the tibial nerve with an electrical current, the Soleus H-reflex will be obtained. Its peak to peak amplitude will be measured in microvolts.
Change from baseline in T-reflex
Time frame: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Soleus T-reflex will be obtained by hitting the Achilles tendon with the electronic reflex hammer. Its peak to peak amplitude will be measured in microvolts.
1 secondary outcome
Skin temperature
Time frame: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
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 27 Apr 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.
ILHAN KARACAN, MD, Prof 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 Brief skin cooling 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 27 Apr 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?
Change from baseline in Heart rate (time frame: Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test). The study lists 3 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 27 Apr 2023.