Nerve Conduction Block Using Transcutaneous Electrical Currents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.

Detailed Description
-----------------
In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents). It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason the investigators decided to applied 20KHz to observe the effects on maximal manual force and to compare versus sham stimulation. Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.

Official Title
-----------------
Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study

Conditions
-----------------
Nerve Block, Electric Stimulation

Intervention / Treatment
-----------------
* Device: High-Frequency Stimulation
* Device: sham Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Neuromuscular disease. Epilepsy. Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Frequency<br>Transcutaneous application of high frequency electrical current over the arm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. | Device: High-Frequency Stimulation<br>* high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>|
| Sham Comparator: Sham stimulation<br>Electrodes are placed over the arm for a 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel | Device: sham Stimulation<br>* Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Hand Muscle Strength | The hand muscle strength will be measured with a dynamometer and will be expressed in Newton | Baseline at 0 min | 
| Hand muscle strength after treatment 20 min | The hand muscle strength will be measured with a dynamometer and will be expressed in Newton | After treatment 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Muscle strength | The hand muscle strength will be measured with a dynamometer and will be expressed in Newton | baseline at 0 min, immediately after treatment at 20 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nerve conduction block, high frequency stimulation, handgrip