Nerve Conduction Block Using Transcutaneous Electrical Currents
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|ClinicalTrials.gov Identifier: NCT03169049|
Recruitment Status : Unknown
Verified May 2017 by University of Castilla-La Mancha.
Recruitment status was: Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nerve Block Electric Stimulation||Device: High-Frequency Stimulation Device: sham Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study|
|Estimated Study Start Date :||July 2017|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||September 2017|
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
high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham Comparator: Sham stimulation
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
Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
- Baseline Hand Muscle Strength [ Time Frame: Baseline at 0 min ]The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
- Hand muscle strength after treatment 20 min [ Time Frame: After treatment 20 min ]The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
- Change from baseline in Muscle strength [ Time Frame: baseline at 0 min, immediately after treatment at 20 min ]The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169049
|Contact: Diego Serrano-Muñoz, MsC||+34 925 24 77 00 ext email@example.com|
|Contact: Julio Gómez-Soriano, PhD||+34 925 26 88 00 ext firstname.lastname@example.org|
|Principal Investigator:||Diego Serrano-Muñoz, MsC||Hospital Nacional de Parapléjicos, Toledo|