Pain
Conditions
Keywords
Transcutaneous Electric Nerve Stimulation, Electric Stimulation Therapy, Unmodulated Alternating Currents, Neural Conduction, Pain Threshold
Brief summary
The purpose of this study is to determine whether the transcutaneous application of unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover evidence whether the effect and comfort of this current is greater than Conventional TENS (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical pain.
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.
Interventions
DEVICE5 KHz
5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
DEVICETENS
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
DEVICESham stimulation
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sponsors
Hospital Nacional de Parapléjicos de Toledo
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
Exclusion criteria
* Neuromuscular disease. * Epilepsy. * Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. * Osteosynthesis material in the upper limb. * Diabetes. * Cancer. * Cardiovascular disease. * Pacemaker or other implanted electrical device. * Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. * Presence of tattoos or other external agent introduced into the treatment or assessment area. * Pregnancy. * Sensitivity disturbance in upper limb.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tactile Threshold During Treatment | during treatment at 15 min. | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
| Mechanical Pain Threshold During Treatment | 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 | 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 | immediately after treatment at 20 min. | The compound action potential latencies will be measured and will be expressed in ms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nerve Conduction Amplitude ( µV) | Baseline,immediately after treatment at 20 min.. | The compound action potential amplitudes ( µV) will be measured. |
| Baseline Mechanical Pain Threshold | Baseline at 0 min. | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton |
| Mechanical Pain Threshold Post-treatment 20 Min. | at 20 min. post-treatment | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton |
| Mechanical Pain Threshold Post-treatment 40 Min. | at 40 min. post-treatment | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton. |
| Baseline Thermal Pain Threshold | 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 |
| Thermal Pain Threshold Post-treatment 20 Min. | at 20 min. post-treatment | The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC |
| Baseline Nerve Conduction Latency | Baseline at 0 min. | The compound action potential latencies will be measured and will be expressed in ms. |
| Nerve Conduction Latency Post-treatment 20 Min. | at 20 min. post-treatment | The compound action potential latencies will be measured and will be expressed in ms. |
| Nerve Conduction Latency Post-treatment 40 Min. | at 40 min. post-treatment | The compound action potential latencies will be measured and will be expressed in ms. |
| Baseline Tactile Threshold | Baseline at 0 min. | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
| Tactile Threshold Post-treatment 20 Min. | at 20 min. post-treatment | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
| Tactile Threshold Post-treatment 40 Min. | at 40 min. post-treatment | The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton |
| Thermal Pain Threshold Post-treatment 40 Min. | at 40 min. post-treatment | The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC |
| Habituation to Electrical Stimulation | Start treatment session (1 min), end treatment session (20 min) | The habituation to electrical stimulation along experimental session will be measured by recording the difference on current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min) |
| Perception Current Comfortability | At the end of the third experimental session, 3 days | Participants will choose the current treatment that has found more comfortable |
| Change Current Density (mA/cm2) | at 1 min. treatment session, at 20 min. treatment session | Change in current density (mA/cm2), it will be recorded at 1 min. start of the treatment session and at 20 min of the same. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Skin Temperature | Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment | Skin temperature (ºC) will be recorded in all assessment times. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants who were randomized to receive either 5 KHz, TENS or Sham Stimulation | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 21.4 years STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 | 0 / 38 |
Outcome results
Primary
Mechanical Pain Threshold During Treatment
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Time frame: during treatment at 15 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Mechanical Pain Threshold During Treatment | 57.5 N | Standard Deviation 2.2 |
| TENS | Mechanical Pain Threshold During Treatment | 63.2 N | Standard Deviation 3.1 |
| Sham Stimulation | Mechanical Pain Threshold During Treatment | 53.8 N | Standard Deviation 2 |
p-value: <0.001ANOVA
Primary
Nerve Conduction Latency Immediately After Treatment
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: immediately after treatment at 20 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Nerve Conduction Latency Immediately After Treatment | 3.71 ms | Standard Deviation 0.04 |
| TENS | Nerve Conduction Latency Immediately After Treatment | 3.68 ms | Standard Deviation 0.04 |
| Sham Stimulation | Nerve Conduction Latency Immediately After Treatment | 3.63 ms | Standard Deviation 0.04 |
p-value: 0.9ANOVA
Primary
Tactile Threshold During Treatment
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: during treatment at 15 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Tactile Threshold During Treatment | 18.3 mN | Standard Deviation 4.9 |
| TENS | Tactile Threshold During Treatment | 74.5 mN | Standard Deviation 10.3 |
| Sham Stimulation | Tactile Threshold During Treatment | 1.1 mN | Standard Deviation 0.9 |
p-value: 0.001ANOVA
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
Time frame: during treatment at 15 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Thermal Pain Threshold During Treatment | 57.48 ºC | Standard Deviation 2.15 |
| TENS | Thermal Pain Threshold During Treatment | 63.16 ºC | Standard Deviation 3.08 |
| Sham Stimulation | Thermal Pain Threshold During Treatment | 53.82 ºC | Standard Deviation 2 |
p-value: 0.04ANOVA
Secondary
Baseline Mechanical Pain Threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Time frame: Baseline at 0 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Baseline Mechanical Pain Threshold | 48.4 N | Standard Deviation 1.7 |
| TENS | Baseline Mechanical Pain Threshold | 48.3 N | Standard Deviation 1.7 |
| Sham Stimulation | Baseline Mechanical Pain Threshold | 54.0 N | Standard Deviation 1.9 |
p-value: 0.02ANOVA
Secondary
Baseline Nerve Conduction Latency
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: Baseline at 0 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Baseline Nerve Conduction Latency | 3.6 ms | Standard Deviation 0.04 |
| TENS | Baseline Nerve Conduction Latency | 3.6 ms | Standard Deviation 0.04 |
| Sham Stimulation | Baseline Nerve Conduction Latency | 3.6 ms | Standard Deviation 0.03 |
p-value: 0.9ANOVA
Secondary
Baseline Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: Baseline at 0 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Baseline Tactile Threshold | 1.1 mN | Standard Deviation 0.08 |
| TENS | Baseline Tactile Threshold | 1.0 mN | Standard Deviation 0 |
| Sham Stimulation | Baseline Tactile Threshold | 1.0 mN | Standard Deviation 0 |
p-value: 0.6ANOVA
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
Time frame: Baseline at 0 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Baseline Thermal Pain Threshold | 44.9 ºC | Standard Deviation 0.4 |
| TENS | Baseline Thermal Pain Threshold | 45.0 ºC | Standard Deviation 0.3 |
| Sham Stimulation | Baseline Thermal Pain Threshold | 44.8 ºC | Standard Deviation 0.3 |
p-value: 1ANOVA
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.
Time frame: at 1 min. treatment session, at 20 min. treatment session
Population: Sham stimulation arm was not included in the analysis of change current density because in the Sham group no current was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Change Current Density (mA/cm2) | 0.62 mA/cm2 | Standard Deviation 0.25 |
| TENS | Change Current Density (mA/cm2) | 0.44 mA/cm2 | Standard Deviation 0.19 |
p-value: 0.003t-test, 2 sided
Secondary
Change From Baseline in Nerve Conduction Amplitude ( µV)
The compound action potential amplitudes ( µV) will be measured.
Time frame: Baseline,immediately after treatment at 20 min..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Change From Baseline in Nerve Conduction Amplitude ( µV) | -0.09 µV | Standard Error 0.01 |
| TENS | Change From Baseline in Nerve Conduction Amplitude ( µV) | 0.03 µV | Standard Error 0.02 |
| Sham Stimulation | Change From Baseline in Nerve Conduction Amplitude ( µV) | -0.4 µV | Standard Error 0.15 |
p-value: 0.8ANOVA
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)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Habituation to Electrical Stimulation | 7.7 mA | Standard Deviation 3.1 |
| TENS | Habituation to Electrical Stimulation | 5.5 mA | Standard Deviation 2.3 |
p-value: 0.003t-test, 2 sided
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
Time frame: at 20 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Mechanical Pain Threshold Post-treatment 20 Min. | 53.8 N | Standard Deviation 1.8 |
| TENS | Mechanical Pain Threshold Post-treatment 20 Min. | 55.2 N | Standard Deviation 1.7 |
| Sham Stimulation | Mechanical Pain Threshold Post-treatment 20 Min. | 51.5 N | Standard Deviation 1.8 |
p-value: 0.4ANOVA
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.
Time frame: at 40 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Mechanical Pain Threshold Post-treatment 40 Min. | 52.0 N | Standard Deviation 2.1 |
| TENS | Mechanical Pain Threshold Post-treatment 40 Min. | 52.6 N | Standard Deviation 1.8 |
| Sham Stimulation | Mechanical Pain Threshold Post-treatment 40 Min. | 51.0 N | Standard Deviation 1.7 |
p-value: 0.8ANOVA
Secondary
Nerve Conduction Latency Post-treatment 20 Min.
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: at 20 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Nerve Conduction Latency Post-treatment 20 Min. | 3.7 ms | Standard Deviation 0.5 |
| TENS | Nerve Conduction Latency Post-treatment 20 Min. | 3.7 ms | Standard Deviation 0.5 |
| Sham Stimulation | Nerve Conduction Latency Post-treatment 20 Min. | 3.7 ms | Standard Deviation 0.4 |
p-value: 0.9ANOVA
Secondary
Nerve Conduction Latency Post-treatment 40 Min.
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: at 40 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Nerve Conduction Latency Post-treatment 40 Min. | 3.7 ms | Standard Deviation 0.5 |
| TENS | Nerve Conduction Latency Post-treatment 40 Min. | 3.7 ms | Standard Deviation 0.4 |
| Sham Stimulation | Nerve Conduction Latency Post-treatment 40 Min. | 3.6 ms | Standard Deviation 0.4 |
p-value: 0.5ANOVA
Secondary
Perception Current Comfortability
Participants will choose the current treatment that has found more comfortable
Time frame: At the end of the third experimental session, 3 days
Population: Sham stimulation arm was not included in the analysis of perception current comfortability because in the Sham group no current was applied.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 KHz | Perception Current Comfortability | 26 Participants |
| TENS | Perception Current Comfortability | 12 Participants |
p-value: 0.023Chi-squared
Secondary
Tactile Threshold Post-treatment 20 Min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: at 20 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Tactile Threshold Post-treatment 20 Min. | 1.4 mN | Standard Deviation 0.16 |
| TENS | Tactile Threshold Post-treatment 20 Min. | 1.5 mN | Standard Deviation 0.2 |
| Sham Stimulation | Tactile Threshold Post-treatment 20 Min. | 1.0 mN | Standard Deviation 0.02 |
p-value: 0.1ANOVA
Secondary
Tactile Threshold Post-treatment 40 Min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: at 40 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Tactile Threshold Post-treatment 40 Min. | 1.3 mN | Standard Deviation 0.1 |
| TENS | Tactile Threshold Post-treatment 40 Min. | 1.1 mN | Standard Deviation 0.08 |
| Sham Stimulation | Tactile Threshold Post-treatment 40 Min. | 1.0 mN | Standard Deviation 0.02 |
p-value: 0.2ANOVA
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
Time frame: at 20 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Thermal Pain Threshold Post-treatment 20 Min. | 45.1 ºC | Standard Deviation 0.4 |
| TENS | Thermal Pain Threshold Post-treatment 20 Min. | 45.4 ºC | Standard Deviation 0.4 |
| Sham Stimulation | Thermal Pain Threshold Post-treatment 20 Min. | 45.0 ºC | Standard Deviation 0.4 |
p-value: 0.4ANOVA
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
Time frame: at 40 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Thermal Pain Threshold Post-treatment 40 Min. | 45.2 ºC | Standard Deviation 0.3 |
| TENS | Thermal Pain Threshold Post-treatment 40 Min. | 45.7 ºC | Standard Deviation 0.3 |
| Sham Stimulation | Thermal Pain Threshold Post-treatment 40 Min. | 45.2 ºC | Standard Deviation 0.4 |
p-value: 0.1ANOVA
Other Pre-specified
Skin Temperature
Skin temperature (ºC) will be recorded in all assessment times.
Time frame: Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 KHz | Skin Temperature | 31.3 ºC | Standard Deviation 0.18 |
| TENS | Skin Temperature | 31.4 ºC | Standard Deviation 0.19 |
| Sham Stimulation | Skin Temperature | 31.3 ºC | Standard Deviation 0.2 |
p-value: 1ANOVA