Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers
- Conditions
- Electrical StimulationNeuromodulation
- Interventions
- Device: Sham stimulation (Myomed 932, Enraf-Nonius)Device: 20 kHz stimulation (Myomed 932, Enraf-Nonius)Device: 10 kHz stimulation (Myomed 932, Enraf-Nonius)
- Registration Number
- NCT04346719
- Lead Sponsor
- University of Castilla-La Mancha
- 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
Our previous studies with transcutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham stimulation Sham stimulation (Myomed 932, Enraf-Nonius) 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. 20 kHz stimulation 20 kHz stimulation (Myomed 932, Enraf-Nonius) 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. 10 kHz stimulation 10 kHz stimulation (Myomed 932, Enraf-Nonius) 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.
- Primary Outcome Measures
Name Time Method Muscle strength Immediately after treatment at 30 minutes Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Antidromic median sensory nerve action potential Immediately after treatment at 30 minutes The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Negative peak latency (NPL), positive peak latency (PPL), and peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED).
Decrement (elasticity) of tissue assessed by MyotonPro Immediately after treatment at 30 minutes This outcome measure is obtained by a device named MyotonPro. The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction. The muscle will be assessed is opponens pollicis muscle
Tactile Threshold Immediately after treatment at 30 minutes The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Stiffness of tissue assessed by MyotonPro Immediately after treatment at 30 minutes This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle. The muscle will be assessed is opponens pollicis muscle
Oscillation Frequency of tissue assessed by MyotonPro Immediately after treatment at 30 minutes This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone. The muscle will be assessed is opponens pollicis muscle
Pressure Pain Threshold Immediately after treatment at 30 minutes The PPT will be measured with an algometer and will be expressed in Newtons
- Secondary Outcome Measures
Name Time Method Number of participants with intervention-related adverse effects After the intervention at 35 minutes the possible adverse effects caused by the interventions will be assess by a questionnaire
Blinding success After the intervention at 35 minutes Blinding of subjects and researchers will be assessed using the James Index
Baseline flux temperature Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes Flux will be measured using a termodoppler
Numerical Pain Rate Score After the intervention at 35 minutes The NRS consists of a scale from 0 (no pain) to 10 (worst possible pain)
Baseline nerve temperature Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes Nerve temperature will be measured using a termodoppler (Celsius degrees)
Numerical Discomfort Rate Score After the intervention at 35 minutes the possible discomfort caused by the interventions will be assess by a numerical rate score. The NRS consists of a scale from 0 (no discomfort) to 10 (worst possible discomfort)
Trial Locations
- Locations (1)
Castilla-La Mancha University
🇪🇸Toledo, Spain