Clinical trial NCT02320838: Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction
Official title: Unmodulated 5 Kilohertz Alternating Currents Versus TENS: Effect on Mechanical and Thermal Pain Thresholds, Tactile Threshold, and Peripheral Nerve Conduction in Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Transcutaneous Electric Nerve Stimulation
Electric Stimulation Therapy
Unmodulated Alternating Currents
Neural Conduction
Pain Threshold
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2014-12-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: 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 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover evidence whether the effect and comfort of this current is greater than Conventional TENS (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical pain.

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)

This evidences in animals could have application in pain treatment, characterized by overactive nervous system. For this reason it was decided to compare the effects on experimental pain and peripheral nerve conduction of this new electric current versus sham stimulation and TENS (Transcutaneous Electrical Nerve Stimulation).

The scientific literature on transcutaneous electrical stimulation in humans and changes in nerve conduction and / or somatosensory thresholds focuses mainly on TENS (Transcutaneous Electrical Nerve Stimulation). Therefore TENS is a good reference standard to compare the effect of this new currents.

Eligibility criteria: Inclusion Criteria:

* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

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.
* Sensitivity disturbance in upper limb.

Primary outcomes:
measure: Mechanical Pain Threshold During Treatment
timeFrame: during treatment at 15 min
measure: Thermal Pain Threshold During Treatment
timeFrame: during treatment at 15 min.
measure: Nerve Conduction Latency Immediately After Treatment
timeFrame: immediately after treatment at 20 min.
measure: Tactile Threshold During Treatment
timeFrame: during treatment at 15 min.
Secondary outcomes:
measure: Habituation to Electrical Stimulation
timeFrame: Start treatment session (1 min), end treatment session (20 min)
measure: Perception Current Comfortability
timeFrame: At the end of the third experimental session, 3 days
measure: Change Current Density (mA/cm2)
timeFrame: at 1 min. treatment session, at 20 min. treatment session
measure: Change From Baseline in Nerve Conduction Amplitude ( µV)
timeFrame: Baseline,immediately after treatment at 20 min..
measure: Baseline Mechanical Pain Threshold
timeFrame: Baseline at 0 min.
measure: Mechanical Pain Threshold Post-treatment 20 Min.
timeFrame: at 20 min. post-treatment
measure: Mechanical Pain Threshold Post-treatment 40 Min.
timeFrame: at 40 min. post-treatment
measure: Baseline Thermal Pain Threshold
timeFrame: Baseline at 0 min.
measure: Thermal Pain Threshold Post-treatment 20 Min.
timeFrame: at 20 min. post-treatment
measure: Thermal Pain Threshold Post-treatment 40 Min.
timeFrame: at 40 min. post-treatment
measure: Baseline Nerve Conduction Latency
timeFrame: Baseline at 0 min.
measure: Nerve Conduction Latency Post-treatment 20 Min.
timeFrame: at 20 min. post-treatment
measure: Nerve Conduction Latency Post-treatment 40 Min.
timeFrame: at 40 min. post-treatment
measure: Baseline Tactile Threshold
timeFrame: Baseline at 0 min.
measure: Tactile Threshold Post-treatment 20 Min.
timeFrame: at 20 min. post-treatment
measure: Tactile Threshold Post-treatment 40 Min.
timeFrame: at 40 min. post-treatment
Other outcomes:
measure: Skin Temperature
timeFrame: Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment
Locations:
Study officials:
affiliation: University of Castilla-La Mancha, Toledo, Spain
name: Juan Avendaño-Coy, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avendano-Coy J, Gomez-Soriano J, Goicoechea-Garcia C, Basco-Lopez JA, Taylor J. Effect of Unmodulated 5-kHz Alternating Currents Versus Transcutaneous Electrical Nerve Stimulation on Mechanical and Thermal Pain, Tactile Threshold, and Peripheral Nerve Conduction: A Double-Blind, Placebo-Controlled Crossover Trial. Arch Phys Med Rehabil. 2017 May;98(5):888-895. doi: 10.1016/j.apmr.2016.11.020. Epub 2016 Dec 23.