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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05832970
Other study ID # CIMFSA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2023
Est. completion date April 8, 2023

Study information

Verified date April 2023
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date April 8, 2023
Est. primary completion date April 7, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - Being healthy - Being a young adult (20-45 years old) - Volunteer Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Brief skin cooling
Brief skin cooling will be applied to the hand using the cold-bath immersion

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training & Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Primary 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. Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Primary 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. Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
Secondary 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. Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test
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