Trial Outcomes & Findings for Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction (NCT NCT02320838)
NCT ID: NCT02320838
Last Updated: 2017-07-31
Results Overview
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
during treatment at 15 min
Results posted on
2017-07-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
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First Intervention (1 Day)
STARTED
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8
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8
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8
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7
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7
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First Intervention (1 Day)
COMPLETED
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8
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8
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8
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7
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7
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First Intervention (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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Washout (1 Day)
STARTED
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8
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8
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8
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7
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7
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Washout (1 Day)
COMPLETED
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8
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8
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8
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7
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7
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Washout (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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Second Intervention (1 Day)
STARTED
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8
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8
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8
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7
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7
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Second Intervention (1 Day)
COMPLETED
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8
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8
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8
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7
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7
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Second Intervention (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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Third Intervention (1 Day)
STARTED
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8
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8
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8
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7
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7
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Third Intervention (1 Day)
COMPLETED
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8
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8
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8
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7
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7
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Third Intervention (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction
Baseline characteristics by cohort
| Measure |
All Participants
n=38 Participants
Participants who were randomized to receive either 5 KHz, TENS or Sham Stimulation
|
|---|---|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 2.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: during treatment at 15 minThe pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Mechanical Pain Threshold During Treatment
|
57.5 N
Standard Deviation 2.2
|
63.2 N
Standard Deviation 3.1
|
53.8 N
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Thermal Pain Threshold During Treatment
|
57.48 ºC
Standard Deviation 2.15
|
63.16 ºC
Standard Deviation 3.08
|
53.82 ºC
Standard Deviation 2.00
|
PRIMARY outcome
Timeframe: immediately after treatment at 20 min.The compound action potential latencies will be measured and will be expressed in ms.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Nerve Conduction Latency Immediately After Treatment
|
3.71 ms
Standard Deviation 0.04
|
3.68 ms
Standard Deviation 0.04
|
3.63 ms
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: during treatment at 15 min.The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Tactile Threshold During Treatment
|
18.3 mN
Standard Deviation 4.9
|
74.5 mN
Standard Deviation 10.3
|
1.1 mN
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Start treatment session (1 min), end treatment session (20 min)Population: "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
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)
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
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)
|
|---|---|---|---|
|
Habituation to Electrical Stimulation
|
7.7 mA
Standard Deviation 3.1
|
5.5 mA
Standard Deviation 2.3
|
—
|
SECONDARY outcome
Timeframe: At the end of the third experimental session, 3 daysPopulation: "Sham stimulation" arm was not included in the analysis of perception current comfortability because in the Sham group no current was applied.
Participants will choose the current treatment that has found more comfortable
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
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)
|
|---|---|---|---|
|
Perception Current Comfortability
|
26 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: at 1 min. treatment session, at 20 min. treatment sessionPopulation: "Sham stimulation" arm was not included in the analysis of "change current density" because in the Sham group no current was applied.
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.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
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)
|
|---|---|---|---|
|
Change Current Density (mA/cm2)
|
0.62 mA/cm2
Standard Deviation 0.25
|
0.44 mA/cm2
Standard Deviation 0.19
|
—
|
SECONDARY outcome
Timeframe: Baseline,immediately after treatment at 20 min..The compound action potential amplitudes ( µV) will be measured.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Change From Baseline in Nerve Conduction Amplitude ( µV)
|
-0.09 µV
Standard Error 0.01
|
0.03 µV
Standard Error 0.02
|
-0.4 µV
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline at 0 min.The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Baseline Mechanical Pain Threshold
|
48.4 N
Standard Deviation 1.7
|
48.3 N
Standard Deviation 1.7
|
54.0 N
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: at 20 min. post-treatmentThe pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Mechanical Pain Threshold Post-treatment 20 Min.
|
53.8 N
Standard Deviation 1.8
|
55.2 N
Standard Deviation 1.7
|
51.5 N
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: at 40 min. post-treatmentThe pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Mechanical Pain Threshold Post-treatment 40 Min.
|
52.0 N
Standard Deviation 2.1
|
52.6 N
Standard Deviation 1.8
|
51.0 N
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Baseline Thermal Pain Threshold
|
44.9 ºC
Standard Deviation 0.4
|
45.0 ºC
Standard Deviation 0.3
|
44.8 ºC
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: at 20 min. post-treatmentThe heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Thermal Pain Threshold Post-treatment 20 Min.
|
45.1 ºC
Standard Deviation 0.4
|
45.4 ºC
Standard Deviation 0.4
|
45.0 ºC
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: at 40 min. post-treatmentThe heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Thermal Pain Threshold Post-treatment 40 Min.
|
45.2 ºC
Standard Deviation 0.3
|
45.7 ºC
Standard Deviation 0.3
|
45.2 ºC
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline at 0 min.The compound action potential latencies will be measured and will be expressed in ms.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Baseline Nerve Conduction Latency
|
3.6 ms
Standard Deviation 0.04
|
3.6 ms
Standard Deviation 0.04
|
3.6 ms
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: at 20 min. post-treatmentThe compound action potential latencies will be measured and will be expressed in ms.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Nerve Conduction Latency Post-treatment 20 Min.
|
3.7 ms
Standard Deviation 0.5
|
3.7 ms
Standard Deviation 0.5
|
3.7 ms
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: at 40 min. post-treatmentThe compound action potential latencies will be measured and will be expressed in ms.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Nerve Conduction Latency Post-treatment 40 Min.
|
3.7 ms
Standard Deviation 0.5
|
3.7 ms
Standard Deviation 0.4
|
3.6 ms
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline at 0 min.The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Baseline Tactile Threshold
|
1.1 mN
Standard Deviation 0.08
|
1.0 mN
Standard Deviation 0.00
|
1.0 mN
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: at 20 min. post-treatmentThe tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Tactile Threshold Post-treatment 20 Min.
|
1.4 mN
Standard Deviation 0.16
|
1.5 mN
Standard Deviation 0.2
|
1.0 mN
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: at 40 min. post-treatmentThe tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Tactile Threshold Post-treatment 40 Min.
|
1.3 mN
Standard Deviation 0.1
|
1.1 mN
Standard Deviation 0.08
|
1.0 mN
Standard Deviation 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatmentSkin temperature (ºC) will be recorded in all assessment times.
Outcome measures
| Measure |
5 KHz
n=38 Participants
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)
|
TENS
n=38 Participants
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)
|
Sham Stimulation
n=38 Participants
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)
|
|---|---|---|---|
|
Skin Temperature
|
31.3 ºC
Standard Deviation 0.18
|
31.4 ºC
Standard Deviation 0.19
|
31.3 ºC
Standard Deviation 0.2
|
Adverse Events
5 KHz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juan Avendaño Coy
Universidad de Castilla-La Mancha
Phone: +34 925268800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place