Effect of High Frequency Electrical Currents in Healthy Subjects.

University of Castilla-La Mancha

Status: Completed

Conditions: High Frequency Current

Treatments: Device: Sham Stimulation; Device: High-Frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT02837458

ddsm18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups

High-Frequency

Experimental group

Description:

Transcutaneous application of high frequency electrical current over the arm for a 30 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.

Treatment:

Device: High-Frequency

Sham Stimulation

Sham Comparator group

Description:

Electrodes are placed over the arm for a 30 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.

Treatment:

Device: Sham Stimulation