High Frequency CurrentNCT02837458
Effect of High Frequency Electrical Currents in Healthy Subjects.
A study testing High-Frequency in people with High Frequency Current, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Frequency Current
- What is being tested?
- High-Frequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.
Read the detailed description
In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents).
It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason we decided to applied 30KHz to observe the effects on pain in patients with whiplash and to compare versus sham stimulation.
Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.
- Conditions
- High Frequency Current
- Being tested
- High-Frequency, Sham Stimulation
- Keywords
- Electric current, Nerve block, somatosensory evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-FrequencyDevice
high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham StimulationDevice
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| High-Frequency | Experimental | Transcutaneous application of high frequency electrical current over the arm for a 30 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Receives: Device: High-Frequency |
| Sham Stimulation | Sham comparator | Electrodes are placed over the arm for a 30 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Mechanical Pain Threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Measured: baseline at 0 min
Baseline Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: baseline at 0 min
Baseline Muscle Strength
The muscle strength will be measured with a dynamometer and will be expressed in Newton
Measured: Baseline at 0 min
Mechanical Pain Threshold after treatment at 30 min
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Measured: Immediately after treatment at 30 min
Tactile Threshold after treatment at 30 min
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: Immediately after treatment at 30 min
Muscle Strength after treatment at 30 min
The muscle strength will be measured with a dynamometer and will be expressed in Newton
Measured: Immediately after treatment at 30 min
Secondary outcomes (3)
Change from baseline in Mechanical Pain Threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Measured: baseline at 0 min, immediately after treatment at 30 min
Change from baseline in TactileThreshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: baseline at 0 min, immediately after treatment at 30 min
Change from baseline in Muscle strength
The muscle strength will be measured with a dynamometer and will be expressed in Newton
Measured: baseline at 0 min, immediately after treatment at 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start1 May 2017
- Primary completion30 Sep 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Frequency CurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Diego Serrano-Muñoz, MsC, Principal investigator, Hospital Nacional de Parapléjicos, Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837458
- Sponsor's protocol ID
- ddsm18
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2016
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.
PubMed 32075666
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02837458
- Acronym / sponsor ID
- ddsm18
- Conditions
- High Frequency Current
- Keywords
- Electric current, Nerve block, somatosensory evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.
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).
It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason we decided to applied 30KHz to observe the effects on pain in patients with whiplash and to compare versus sham stimulation.
Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Frequency | Experimental | Device: High-FrequencyTranscutaneous application of high frequency electrical current over the arm for a 30 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. |
| Sham Stimulation | Sham comparator | Device: Sham StimulationElectrodes are placed over the arm for a 30 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (11 listed)
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Frequencyhigh-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | High-Frequency |
| Sham StimulationSham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | Sham Stimulation |
Primary outcome
Baseline Mechanical Pain Threshold
Time frame: baseline at 0 min
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Baseline Tactile Threshold
Time frame: baseline at 0 min
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Baseline Muscle Strength
Time frame: Baseline at 0 min
The muscle strength will be measured with a dynamometer and will be expressed in Newton
Mechanical Pain Threshold after treatment at 30 min
Time frame: Immediately after treatment at 30 min
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Tactile Threshold after treatment at 30 min
Time frame: Immediately after treatment at 30 min
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Muscle Strength after treatment at 30 min
Time frame: Immediately after treatment at 30 min
The muscle strength will be measured with a dynamometer and will be expressed in Newton
3 secondary outcomes
Change from baseline in Mechanical Pain Threshold
Time frame: baseline at 0 min, immediately after treatment at 30 min
Change from baseline in TactileThreshold
Time frame: baseline at 0 min, immediately after treatment at 30 min
Change from baseline in Muscle strength
Time frame: baseline at 0 min, immediately after treatment at 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 32075666Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Serrano-Muñoz, MsC principal investigator
Hospital Nacional de Parapléjicos, Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency in people with High Frequency Current, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Mechanical Pain Threshold (time frame: baseline at 0 min). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.