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| Name | Class |
|---|---|
| Hospital Nacional de Parapléjicos de Toledo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 KHz | Device | 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Pain Threshold During Treatment | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton | 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 | 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. | 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 | during treatment at 15 min. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Start treatment session (1 min), end treatment session (20 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Temperature | Skin temperature (ºC) will be recorded in all assessment times. | Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Avendaño-Coy, MsC | University of Castilla-La Mancha, Toledo, Spain | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28017706 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 KHz First, Then TENS and Then Sham | 5KHz: 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. 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. 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. |
| FG001 | TENS First, Then 5 KHz and Then Sham | 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 5KHz: 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. 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. |
| FG002 | Sham First, Then TENS and Then 5KHz | 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. 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 5KHz: 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. |
| FG003 | TENS First, Then Sham and Then 5KHz | ENS: 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 5KHz: 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. 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. |
| FG004 | 5 KHz First, Then Sham and Then TENS | 5KHz: 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (1 Day) |
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| Second Intervention (1 Day) |
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| Washout (1 Day) |
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| Third Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who were randomized to receive either 5 KHz, TENS or Sham Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mechanical Pain Threshold During Treatment | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton | Posted | Mean | Standard Deviation | N | during treatment at 15 min |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juan Avendaño Coy | Universidad de Castilla-La Mancha | +34 925268800 | 5014 | juan.avendano@uclm.es |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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) |
|
| Perception Current Comfortability |
Participants will choose the current treatment that has found more comfortable |
| 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. | 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. | 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 | 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 | 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. | 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 | 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 | 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 | at 40 min. post-treatment |
| Baseline Nerve Conduction Latency | The compound action potential latencies will be measured and will be expressed in ms. | 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. | 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. | at 40 min. post-treatment |
| Baseline Tactile Threshold | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton | 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 | 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 | at 40 min. post-treatment |
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| COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
|
| OG002 | 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. Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
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|
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| Primary | 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 | Posted | Mean | Standard Deviation | ºC | during treatment at 15 min. |
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|
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| Primary | Nerve Conduction Latency Immediately After Treatment | The compound action potential latencies will be measured and will be expressed in ms. | Posted | Mean | Standard Deviation | ms | immediately after treatment at 20 min. |
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| Primary | Tactile Threshold During Treatment | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton | Posted | Mean | Standard Deviation | mN | during treatment at 15 min. |
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| Secondary | 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) | "Sham stimulation" arm was not included in the analysis because for the habituation to the current the increased intensity was measured throughout the session and in the "Sham group" no current was applied | Posted | Mean | Standard Deviation | mA | Start treatment session (1 min), end treatment session (20 min) |
|
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| Secondary | Perception Current Comfortability | Participants will choose the current treatment that has found more comfortable | "Sham stimulation" arm was not included in the analysis of perception current comfortability because in the Sham group no current was applied. | Posted | Count of Participants | Participants | At the end of the third experimental session, 3 days |
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| Secondary | 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. | "Sham stimulation" arm was not included in the analysis of "change current density" because in the Sham group no current was applied. | Posted | Mean | Standard Deviation | mA/cm2 | at 1 min. treatment session, at 20 min. treatment session |
|
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| Secondary | Change From Baseline in Nerve Conduction Amplitude ( µV) | The compound action potential amplitudes ( µV) will be measured. | Posted | Mean | Standard Error | µV | Baseline,immediately after treatment at 20 min.. |
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| Secondary | Baseline Mechanical Pain Threshold | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton | Posted | Mean | Standard Deviation | N | Baseline at 0 min. |
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| Secondary | Mechanical Pain Threshold Post-treatment 20 Min. | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton | Posted | Mean | Standard Deviation | N | at 20 min. post-treatment |
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| Secondary | Mechanical Pain Threshold Post-treatment 40 Min. | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton. | Posted | Mean | Standard Deviation | N | at 40 min. post-treatment |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ºC | Baseline at 0 min. |
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | ºC | at 20 min. post-treatment |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ºC | at 40 min. post-treatment |
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| Secondary | Baseline Nerve Conduction Latency | The compound action potential latencies will be measured and will be expressed in ms. | Posted | Mean | Standard Deviation | ms | Baseline at 0 min. |
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| Secondary | Nerve Conduction Latency Post-treatment 20 Min. | The compound action potential latencies will be measured and will be expressed in ms. | Posted | Mean | Standard Deviation | ms | at 20 min. post-treatment |
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| Secondary | Nerve Conduction Latency Post-treatment 40 Min. | The compound action potential latencies will be measured and will be expressed in ms. | Posted | Mean | Standard Deviation | ms | at 40 min. post-treatment |
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| Secondary | Baseline Tactile Threshold | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton | Posted | Mean | Standard Deviation | mN | Baseline at 0 min. |
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| Secondary | Tactile Threshold Post-treatment 20 Min. | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton | Posted | Mean | Standard Deviation | mN | at 20 min. post-treatment |
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| Secondary | Tactile Threshold Post-treatment 40 Min. | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton | Posted | Mean | Standard Deviation | mN | at 40 min. post-treatment |
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| Other Pre-specified | Skin Temperature | Skin temperature (ºC) will be recorded in all assessment times. | Posted | Mean | Standard Deviation | ºC | Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment |
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|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | 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 TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | 0 | 38 | 0 | 38 |
| EG002 | 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. Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | 0 | 38 | 0 | 38 |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |