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NCT Number: NCT02320838

Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 KHz

Device

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

TENS

Device

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

Sham stimulation

Device

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

Primary outcomes

  1. Mechanical Pain Threshold During Treatment

    Time frame: during treatment at 15 min

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

  2. Thermal Pain Threshold During Treatment

    Time frame: during treatment at 15 min.

    The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC

  3. Nerve Conduction Latency Immediately After Treatment

    Time frame: immediately after treatment at 20 min.

    The compound action potential latencies will be measured and will be expressed in ms.

  4. Tactile Threshold During Treatment

    Time frame: during treatment at 15 min.

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

Secondary outcomes

  1. Habituation to Electrical Stimulation

    Time frame: Start treatment session (1 min), end treatment session (20 min)

    The habituation to electrical stimulation along experimental session will be measured by recording the difference on current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min)

  2. Perception Current Comfortability

    Time frame: At the end of the third experimental session, 3 days

    Participants will choose the current treatment that has found more comfortable

  3. Change Current Density (mA/cm2)

    Time frame: at 1 min. treatment session, at 20 min. treatment session

    Change in current density (mA/cm2), it will be recorded at 1 min. start of the treatment session and at 20 min of the same.

  4. Change From Baseline in Nerve Conduction Amplitude ( µV)

    Time frame: Baseline,immediately after treatment at 20 min..

    The compound action potential amplitudes ( µV) will be measured.

  5. Baseline Mechanical Pain Threshold

    Time frame: Baseline at 0 min.

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

  6. Mechanical Pain Threshold Post-treatment 20 Min.

    Time frame: at 20 min. post-treatment

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

  7. Mechanical Pain Threshold Post-treatment 40 Min.

    Time frame: at 40 min. post-treatment

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.

  8. Baseline Thermal Pain Threshold

    Time frame: Baseline at 0 min.

    The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC

  9. Thermal Pain Threshold Post-treatment 20 Min.

    Time frame: at 20 min. post-treatment

    The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC

  10. Thermal Pain Threshold Post-treatment 40 Min.

    Time frame: at 40 min. post-treatment

    The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC

  11. Baseline Nerve Conduction Latency

    Time frame: Baseline at 0 min.

    The compound action potential latencies will be measured and will be expressed in ms.

  12. Nerve Conduction Latency Post-treatment 20 Min.

    Time frame: at 20 min. post-treatment

    The compound action potential latencies will be measured and will be expressed in ms.

  13. Nerve Conduction Latency Post-treatment 40 Min.

    Time frame: at 40 min. post-treatment

    The compound action potential latencies will be measured and will be expressed in ms.

  14. Baseline Tactile Threshold

    Time frame: Baseline at 0 min.

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

  15. Tactile Threshold Post-treatment 20 Min.

    Time frame: at 20 min. post-treatment

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

  16. Tactile Threshold Post-treatment 40 Min.

    Time frame: at 40 min. post-treatment

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

Other outcomes

  1. Skin Temperature

    Time frame: Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment

    Skin temperature (ºC) will be recorded in all assessment times.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Hospital Nacional de Parapléjicos de Toledo

Registry information

Official study title

Unmodulated 5 Kilohertz Alternating Currents Versus TENS: Effect on Mechanical and Thermal Pain Thresholds, Tactile Threshold, and Peripheral Nerve Conduction in Humans.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2014
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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