Clinical trial NCT04884932: Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers With 30kHz
Official title: Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrical Stimulation
Neuromodulation
Keywords: High-frequency alternating current
nerve block
somatosensory threshold
motor threshold
percutaneous electrical stimulation
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has been used in animal studies to produce a motor nerve block. It has been evidenced that frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in primates, whose nerve thickness is more similar to humans.

Detailed description: The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold.

However, the 30 kHz frequency has never been applied, and the hypothesis is that it can produce a greater blockage at the sensitive level and be a more comfortable application for the patient. The purpose of the present work is to determine if a greater blockage of the sensory component of the nerve occurs with this frequency and is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* 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:

* Neuromuscular disease.
* 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

Primary outcomes:
measure: Latency of Antidromic median sensory nerve action potential
timeFrame: Baseline at 0 minutes
measure: Amplitude of Antidromic median sensory nerve action potential
timeFrame: Baseline at 0 minutes
measure: Tactile Threshold
timeFrame: Baseline at 0 minutes
measure: Pressure Pain Threshold
timeFrame: Baseline at 0 minutes
measure: Muscle strength
timeFrame: Baseline at 0 minutes
measure: Tactile Threshold
timeFrame: During treatment at 15 minutes
measure: Pressure Pain Threshold
timeFrame: During treatment at 15 minutes
measure: Latency Antidromic median sensory nerve action potential
timeFrame: Immediately after treatment at 20 minutes
measure: Amplitude Antidromic median sensory nerve action potential
timeFrame: Immediately after treatment at 20 minutes
measure: Tactile Threshold
timeFrame: Immediately after treatment at 20 minutes
measure: Pressure Pain Threshold
timeFrame: Immediately after treatment at 20 minutes
measure: Muscle strength
timeFrame: Immediately after treatment at 20 minutes
measure: Latency Antidromic median sensory nerve action potential
timeFrame: Immediately after treatment at 30 minutes
measure: Amplitude Antidromic median sensory nerve action potential
timeFrame: Immediately after treatment at 30 minutes
measure: Tactile Threshold
timeFrame: Immediately after treatment at 30 minutes
measure: Pressure Pain Threshold
timeFrame: Immediately after treatment at 30 minutes
measure: Muscle strength
timeFrame: Immediately after treatment at 30 minutes
Secondary outcomes:
measure: Baseline nerve temperature
timeFrame: Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
measure: Numerical Discomfort Rate Score
timeFrame: After the intervention at 35 minutes
measure: Numerical Pain Rate Score
timeFrame: After the intervention at 35 minutes
measure: Number of participants with intervention-related adverse effects
timeFrame: After the intervention at 35 minutes
measure: Blinding success
timeFrame: After the intervention at 35 minutes
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Castilla-La Mancha University
Study officials:
affiliation: Castilla-La Mancha University
name: Juan Avendaño-Coy, PhD
role: STUDY_DIRECTOR
References: