Clinical trial NCT02837458: Effect of High Frequency Electrical Currents in Healthy Subjects.
Official title: Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Frequency Current
Keywords: Electric current
Nerve block
somatosensory evaluation
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2016-07-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 we decided to applied 30KHz to observe the effects on pain in patients with whiplash and to compare versus sham stimulation.

Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.

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.

Primary outcomes:
measure: Baseline Mechanical Pain Threshold
timeFrame: baseline at 0 min
measure: Baseline Tactile Threshold
timeFrame: baseline at 0 min
measure: Baseline Muscle Strength
timeFrame: Baseline at 0 min
measure: Mechanical Pain Threshold after treatment at 30 min
timeFrame: Immediately after treatment at 30 min
measure: Tactile Threshold after treatment at 30 min
timeFrame: Immediately after treatment at 30 min
measure: Muscle Strength after treatment at 30 min
timeFrame: Immediately after treatment at 30 min
Secondary outcomes:
measure: Change from baseline in Mechanical Pain Threshold
timeFrame: baseline at 0 min, immediately after treatment at 30 min
measure: Change from baseline in TactileThreshold
timeFrame: baseline at 0 min, immediately after treatment at 30 min
measure: Change from baseline in Muscle strength
timeFrame: baseline at 0 min, immediately after treatment at 30 min
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Diego Serrano-Muñoz
Study officials:
affiliation: Hospital Nacional de Parapléjicos, Toledo
name: Diego Serrano-Muñoz, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.