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Effect of High Frequency Electrical Currents in Healthy Subjects.

Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837458
Enrollment
14
Registered
2016-07-19
Start date
2017-05-01
Completion date
2017-12-20
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Frequency Current

Keywords

Electric current, Nerve block, somatosensory evaluation

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.

Interventions

DEVICEHigh-Frequency

high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

DEVICESham Stimulation

Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Sponsors

Hospital Nacional de Parapléjicos de Toledo
CollaboratorOTHER
University of Castilla-La Mancha
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle Strength after treatment at 30 minImmediately after treatment at 30 minThe muscle strength will be measured with a dynamometer and will be expressed in Newton
Baseline Muscle StrengthBaseline at 0 minThe muscle strength will be measured with a dynamometer and will be expressed in Newton
Mechanical Pain Threshold after treatment at 30 minImmediately after treatment at 30 minThe pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Tactile Threshold after treatment at 30 minImmediately after treatment at 30 minThe tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Baseline Mechanical Pain Thresholdbaseline at 0 minThe pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Baseline Tactile Thresholdbaseline at 0 minThe tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

Secondary

MeasureTime frameDescription
Change from baseline in TactileThresholdbaseline at 0 min, immediately after treatment at 30 minThe tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Change from baseline in Muscle strengthbaseline at 0 min, immediately after treatment at 30 minThe muscle strength will be measured with a dynamometer and will be expressed in Newton
Change from baseline in Mechanical Pain Thresholdbaseline at 0 min, immediately after treatment at 30 minThe pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026