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

• ClinicalTrials.gov Identifier: NCT02320838
• Recruitment Status: Completed
• First Posted: December 19, 2014
• Results First Posted: July 31, 2017
• Last Update Posted: July 31, 2017
• Sponsor: University of Castilla-La Mancha
• Collaborator: Hospital Nacional de Parapléjicos de Toledo
• Information provided by (Responsible Party): University of Castilla-La Mancha

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Device: 5 KHz; Device: TENS; Device: Sham stimulation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: November 2014
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 5 KHz; Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.	Device: 5 KHz; 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Experimental: TENS; Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds	Device: TENS; TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham Comparator: Sham Stimulation; Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.	Device: Sham stimulation; Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

University of Castilla-La Mancha

Hospital Nacional de Parapléjicos de Toledo

Investigators

• Principal Investigator: Juan Avendaño-Coy, MsC; University of Castilla-La Mancha, Toledo, Spain

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Avendaño-Coy J, Gómez-Soriano J, Goicoechea-García C, Basco-López 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.

• Responsible Party: University of Castilla-La Mancha
• ClinicalTrials.gov Identifier: NCT02320838
• Other Study ID Numbers: javendano
• First Posted: December 19, 2014
• Results First Posted: July 31, 2017
• Last Update Posted: July 31, 2017
• Last Verified: July 2017

Keywords provided by University of Castilla-La Mancha:

Transcutaneous Electric Nerve Stimulation; Electric Stimulation Therapy; Unmodulated Alternating Currents; Neural Conduction; Pain Threshold