PainNCT02320838

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

A study testing 5 KHz and TENS in people with Pain, run by University of Castilla-La Mancha.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: 5 KHz and TENS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: No sites listed yet
Study dates: Nov 2014to Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Neuromuscular disease.
Epilepsy.
Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
Osteosynthesis material in the upper limb.
Diabetes.
Cancer.

Show all 12Show fewer

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.

About this study

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

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.

Read the 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.

Conditions: Pain
Being tested: 5 KHz, TENS, Sham stimulation
Keywords: Transcutaneous Electric Nerve Stimulation, Electric Stimulation Therapy, Unmodulated Alternating Currents, Neural Conduction, Pain Threshold
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02320838
Study group	Role	What they receive
5 KHz	Experimental	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. Receives: Device: 5 KHz
TENS	Experimental	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 Receives: Device: TENS
Sham Stimulation	Sham comparator	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. Receives: Device: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Mechanical Pain Threshold During Treatment
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Measured: during treatment at 15 min
Thermal Pain Threshold During Treatment
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Measured: during treatment at 15 min.
Nerve Conduction Latency Immediately After Treatment
The compound action potential latencies will be measured and will be expressed in ms.
Measured: immediately after treatment at 20 min.
Tactile Threshold During Treatment
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: during treatment at 15 min.

Secondary outcomes (16)

Habituation to Electrical Stimulation
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)
Measured: Start treatment session (1 min), end treatment session (20 min)
Perception Current Comfortability
Participants will choose the current treatment that has found more comfortable
Measured: At the end of the third experimental session, 3 days
Change Current Density (mA/cm2)
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.
Measured: at 1 min. treatment session, at 20 min. treatment session
Change From Baseline in Nerve Conduction Amplitude ( µV)
The compound action potential amplitudes ( µV) will be measured.
Measured: Baseline,immediately after treatment at 20 min..
Baseline Mechanical Pain Threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Measured: Baseline at 0 min.
Mechanical Pain Threshold Post-treatment 20 Min.
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Measured: at 20 min. post-treatment
Mechanical Pain Threshold Post-treatment 40 Min.
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Measured: at 40 min. post-treatment
Baseline Thermal Pain Threshold
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Measured: Baseline at 0 min.
Thermal Pain Threshold Post-treatment 20 Min.
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Measured: at 20 min. post-treatment
Thermal Pain Threshold Post-treatment 40 Min.
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Measured: at 40 min. post-treatment
Baseline Nerve Conduction Latency
The compound action potential latencies will be measured and will be expressed in ms.
Measured: Baseline at 0 min.
Nerve Conduction Latency Post-treatment 20 Min.
The compound action potential latencies will be measured and will be expressed in ms.
Measured: at 20 min. post-treatment
Nerve Conduction Latency Post-treatment 40 Min.
The compound action potential latencies will be measured and will be expressed in ms.
Measured: at 40 min. post-treatment
Baseline Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: Baseline at 0 min.
Tactile Threshold Post-treatment 20 Min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: at 20 min. post-treatment
Tactile Threshold Post-treatment 40 Min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: at 40 min. post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Feb 2015

First posted19 Dec 2014 (estimated)
Study startNov 2014
Primary completionJan 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02320838
Sponsor's protocol ID: javendano
Status last verified: Jul 2017
First submitted: 18 Nov 2014
Last updated: 31 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28017706

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unmodulated 5 Kilohertz Alternating Currents Versus TENS: Effect on Mechanical and Thermal Pain Thresholds, Tactile Threshold, and Peripheral Nerve Conduction in Humans.
ClinicalTrials.gov ID: NCT02320838
Acronym / sponsor ID: javendano
Conditions: Pain
Keywords: Transcutaneous Electric Nerve Stimulation, Electric Stimulation Therapy, Unmodulated Alternating Currents, Neural Conduction, Pain Threshold
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of Castilla-La ManchaUniversity, hospital or other
Collaborators: Hospital Nacional de Parapléjicos de Toledo
Study start: Nov 2014
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 19 Dec 2014 (estimated)
Results: Posted 31 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
5 KHz	Experimental	Device: 5 KHzTranscutaneous 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.
TENS	Experimental	Device: TENSTranscutaneous 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
Sham Stimulation	Sham comparator	Device: Sham stimulationElectrodes 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.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (12 listed)

Neuromuscular disease.
Epilepsy.
Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
Osteosynthesis material in the upper limb.
Diabetes.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5 KHz5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)	Device	5 KHz
TENSTENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)	Device	TENS
Sham stimulationSham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)	Device	Sham Stimulation

Primary outcome

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
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
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.
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

16 secondary outcomes

Habituation to Electrical Stimulation
Time frame: Start treatment session (1 min), end treatment session (20 min)
Perception Current Comfortability
Time frame: At the end of the third experimental session, 3 days
Change Current Density (mA/cm2)
Time frame: at 1 min. treatment session, at 20 min. treatment session
Change From Baseline in Nerve Conduction Amplitude ( µV)
Time frame: Baseline,immediately after treatment at 20 min..
Baseline Mechanical Pain Threshold
Time frame: Baseline at 0 min.
Mechanical Pain Threshold Post-treatment 20 Min.
Time frame: at 20 min. post-treatment
Mechanical Pain Threshold Post-treatment 40 Min.
Time frame: at 40 min. post-treatment
Baseline Thermal Pain Threshold
Time frame: Baseline at 0 min.
Thermal Pain Threshold Post-treatment 20 Min.
Time frame: at 20 min. post-treatment
Thermal Pain Threshold Post-treatment 40 Min.
Time frame: at 40 min. post-treatment
Baseline Nerve Conduction Latency
Time frame: Baseline at 0 min.
Nerve Conduction Latency Post-treatment 20 Min.
Time frame: at 20 min. post-treatment
Nerve Conduction Latency Post-treatment 40 Min.
Time frame: at 40 min. post-treatment
Baseline Tactile Threshold
Time frame: Baseline at 0 min.
Tactile Threshold Post-treatment 20 Min.
Time frame: at 20 min. post-treatment
Tactile Threshold Post-treatment 40 Min.
Time frame: at 40 min. post-treatment

Results and safety

Results posted to the registry on 31 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5 KHz First, Then TENS and Then Sham	8	8
TENS First, Then 5 KHz and Then Sham	8	8
Sham First, Then TENS and Then 5KHz	8	8
TENS First, Then Sham and Then 5KHz	7	7
5 KHz First, Then Sham and Then TENS	7	7

Primary outcome: Mechanical Pain Threshold During Treatment

Time frame: during treatment at 15 min. Mean (Standard Deviation). Unit: N

Measure	5 KHz n = 38	TENS n = 38	Sham Stimulation n = 38
Value	57.5 (2.2)	63.2 (3.1)	53.8 (2.0)

5 KHz vs TENS vs Sham Stimulation: p <0.001, ANOVA

Primary outcome: Thermal Pain Threshold During Treatment

Time frame: during treatment at 15 min.. Mean (Standard Deviation). Unit: ºC

Measure	5 KHz n = 38	TENS n = 38	Sham Stimulation n = 38
Value	57.48 (2.15)	63.16 (3.08)	53.82 (2.00)

5 KHz vs TENS vs Sham Stimulation: p = 0.04, ANOVA

Primary outcome: Nerve Conduction Latency Immediately After Treatment

Time frame: immediately after treatment at 20 min.. Mean (Standard Deviation). Unit: ms

Measure	5 KHz n = 38	TENS n = 38	Sham Stimulation n = 38
Value	3.71 (0.04)	3.68 (0.04)	3.63 (0.04)

5 KHz vs TENS vs Sham Stimulation: p = 0.9, ANOVA

Primary outcome: Tactile Threshold During Treatment

Time frame: during treatment at 15 min.. Mean (Standard Deviation). Unit: mN

Measure	5 KHz n = 38	TENS n = 38	Sham Stimulation n = 38
Value	18.3 (4.9)	74.5 (10.3)	1.1 (0.9)

5 KHz vs TENS vs Sham Stimulation: p = 0.001, ANOVA

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5 KHz	0 of 38 (0%)	0 of 38 (0%)	Not reported
TENS	0 of 38 (0%)	0 of 38 (0%)	Not reported
Sham Stimulation	0 of 38 (0%)	0 of 38 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28017706Avendano-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juan Avendaño-Coy, MsC principal investigator

University of Castilla-La Mancha, Toledo, Spain

Questions about this trial

What is this clinical trial studying?

A study testing 5 KHz and TENS in people with Pain, run by University of Castilla-La Mancha.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mechanical Pain Threshold During Treatment (time frame: during treatment at 15 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02320838, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.