Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers
NCT ID: NCT04346719
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-06-01
2020-11-17
Brief Summary
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Detailed Description
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However, in these studies the intensity needed to reach block threshold is very high. The purpose of the present work is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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10 kHz stimulation
Transcutaneous application of high frequency electrical current at 10 kHz over the median nerve for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.
10 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
20 kHz stimulation
Transcutaneous application of high frequency electrical current at 20 kHz over the median nerve for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.
20 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
Sham stimulation
Electrodes are placed over the median nerve for 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity during the first 30 seconds.
Sham stimulation (Myomed 932, Enraf-Nonius)
Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.
Interventions
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10 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
20 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
Sham stimulation (Myomed 932, Enraf-Nonius)
Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.
Eligibility Criteria
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Inclusion Criteria
* Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
* Tolerance to the application of electrotherapy.
* That they have not diagnosed any pathology.
* They do not present a contraindication to puncture and / or the application of electric currents.
Exclusion Criteria
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
18 Years
60 Years
ALL
Yes
Sponsors
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University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Juan Avendaño-Coy, PhD
Role: STUDY_DIRECTOR
Castilla-La Mancha University
Locations
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Castilla-La Mancha University
Toledo, , Spain
Countries
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Other Identifiers
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Neuromodest-pHFAC
Identifier Type: -
Identifier Source: org_study_id