HealthyNCT05500300
Electrical Stimulation With Different Currents and Electromagnetic Fields
A study testing Neo-Russian, Aussie and RBS in people with Healthy, run by Maimonides University at 1 site in Argentina.
Trial summary
Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neo-Russian, Aussie and RBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Aug 2022to 1 Dec 2022
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Male
- Right leg dominant
- Exercising regularly
Who cannot join
- History of injuries in the right leg
- Skin lesions
- Having a pacemaker
- Having a cardiovascular disease.
- Having a neurological disorder.
- Exercise 72 h before the procedure.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Maimonides University
Buenos Aires, Buenos Aires F.D., 1405
Oscar Ronzio, DHSc, +541149051140, ronzio.oscar@maimonides.edu
About this study
Official title: Effects on Isometric Force Induction, Tolerance and Fatigue of Neuromuscular Electrical Stimulation and High Intensity Focused Electromagnetic Field in Healthy Subjects
Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It is claimed that higher MEIC values will result in more force gained.
If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio between Normalized MEIC / VAS is often used, implying that the current is better with a higher ratio.
Read more
Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to previous contractions. It is claimed that medium frequency neuromuscular electrical stimulation (NMES) generates more fatigue than low frequency currents.
Aussie is a medium-frequency alternating current, sinusoidal waveform, 1 KHz carrier frequency.
Neo-Russian is a medium-frequency current, rectangular biphasic symmetrical waveform, 2,5 KHz carrier frequency.
Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC), claimed to be better than classical Russian Current.
Purpose:
As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.
Methods:
Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical stimulation. Before that, the MVIC will be measured for data normalization.
The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements, subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.
To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be used.
The VAS will be used to assess tolerance to each treatment. One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest) of electrical stimulation with the three types of current. The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.
- Conditions
- Healthy
- Being tested
- Neo-Russian, Aussie, RBS, RBS-IPI, HIFEM
- Keywords
- Electrical stimulation, Muscle Strength, Fatigue, Assessments, pain, Electromagnetic Fields, Physiotherapy
- Medical subject headings
- Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-RussianDevice
Subjects will receive Neo-Russian electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured.
They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction.
AussieDevice
Subjects will receive Aussie electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured.
They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction.
RBSDevice
Subjects will receive RBS electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured.
They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction.
RBS-IPIDevice
Subjects will receive RBS-IPI electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured.
They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction.
HIFEMDevice
Subjects will receive HIFEM electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured.
They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction.
| Study group | Role | What they receive |
|---|---|---|
| Neo-Russian Electrical Stimulation | Experimental | Subjects will receive Neo-Russian electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured.
One week later, after a washout period, a fatigue will be done with this type of current. Receives: Device: Neo-Russian |
| Aussie Electrical Stimulation | Experimental | Subjects will receive Aussie electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured.
One week later, after a washout period, a fatigue will be done with this type of current. Receives: Device: Aussie |
| RBS Electrical Stimulation | Experimental | Subjects will receive RBS electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured.
One week later, after a washout period, a fatigue will be done with this type of current. Receives: Device: RBS |
| RBS-IPI Electrical Stimulation | Experimental | Subjects will receive RBS-IPI electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured.
One week later, after a washout period, a fatigue will be done with this type of current. Receives: Device: RBS-IPI |
| HIFEM | Experimental | Subjects will receive HIFEM electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured.
One week later, after a washout period, a fatigue will be done with this type of current. Receives: Device: HIFEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Isometric Contraction (MVIC)
Force generated by the patient during a maximal voluntary isometric contraction, measured by an isometric dynamometer with load cell and computer interface.
The best of the 3 repetitions will be considered. Whenever the third one is the best, additional measurements will be taken until a decrease in torque is obtained in order to determine the maximum.
Unit: Newtons (N)
Measured: Day 1
Maximal Electrical Induced Contraction (MEIC)
Force generated in the muscle while applying electrical stimulation and HIFEM, measured by an isometric dynamometer with load cell and computer interface. This data (in Newtons) will be normalized with the MVIC.
Unit: percentage of MVIC
Measured: Day 1
Visual Analogue Scale
Visual Analogue Scale (VAS): Magnitude of pain, marked in a analogue scale by participants, to determine how unpleasant is each type of stimulation (applied in randomized order).
Expresed in centimeters.
- Minimum value: 0
- Maximum value: 10
- A higher score implicates a worse outcome. VAS wil be evaluated 5 times, 1 per type of stimulation.
Measured: Day 1
Secondary outcomes (1)
Fatigue index
The MEIC decrease between the first and the 21st rep, previously normalized with the MVIC.
- Minimum value: -1
- Maximum value: 1
- The lower the value, the greater the fatigue.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start22 Aug 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 30 male subjects will receive 4 types of electrical stimulation (Aussie, Neo-Russian, Rectangular biphasic symmetric waveform, Rectangular biphasic symmetric waveform with intra-pulse interval) and High Intensity Focused Electromagnetic Field (HIFEM) in a randomized order. Maximal voluntary isometric contraction (MVIC) and maximal elicited induced contraction (MEIC) will be measured with an isometric dynamometer. The best rep will be used. Whenever the third one is the best, additional measurements will be taken until a decrease in torque is obtained to determine the maximum. MVIC will be used for data normalization. The Visual Analogue Scale (VAS) will be used to assess tolerance to treatment. One week later, subjects will receive, randomly, a fatigue protocol with the 4 types of electrical stimulation and the HIFEM, which consists in 21 reps. A fatigue index (FI) will be calculated.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimonides University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500300
- Sponsor's protocol ID
- 5891
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Isometric Force Induction, Tolerance and Fatigue of Neuromuscular Electrical Stimulation and High Intensity Focused Electromagnetic Field in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05500300
- Acronym / sponsor ID
- 5891
- Conditions
- Healthy
- Keywords
- Electrical stimulation, Muscle Strength, Fatigue, Assessments, pain, Electromagnetic Fields, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maimonides UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Aug 2022 (actual)
- 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.
Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It is claimed that higher MEIC values will result in more force gained.
If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio between Normalized MEIC / VAS is often used, implying that the current is better with a higher ratio.
Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to previous contractions. It is claimed that medium frequency neuromuscular electrical stimulation (NMES) generates more fatigue than low frequency currents.
Aussie is a medium-frequency alternating current, sinusoidal waveform, 1 KHz carrier frequency.
Neo-Russian is a medium-frequency current, rectangular biphasic symmetrical waveform, 2,5 KHz carrier frequency.
Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC), claimed to be better than classical Russian Current.
Purpose:
As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.
Methods:
Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical stimulation. Before that, the MVIC will be measured for data normalization.
The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements, subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.
To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be used.
The VAS will be used to assess tolerance to each treatment. One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest) of electrical stimulation with the three types of current. The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 30 male subjects will receive 4 types of electrical stimulation (Aussie, Neo-Russian, Rectangular biphasic symmetric waveform, Rectangular biphasic symmetric waveform with intra-pulse interval) and High Intensity Focused Electromagnetic Field (HIFEM) in a randomized order. Maximal voluntary isometric contraction (MVIC) and maximal elicited induced contraction (MEIC) will be measured with an isometric dynamometer. The best rep will be used. Whenever the third one is the best, additional measurements will be taken until a decrease in torque is obtained to determine the maximum. MVIC will be used for data normalization. The Visual Analogue Scale (VAS) will be used to assess tolerance to treatment. One week later, subjects will receive, randomly, a fatigue protocol with the 4 types of electrical stimulation and the HIFEM, which consists in 21 reps. A fatigue index (FI) will be calculated.
| Arm | Type | Receives |
|---|---|---|
| Neo-Russian Electrical Stimulation | Experimental | Device: Neo-RussianSubjects will receive Neo-Russian electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, a fatigue will be done with this type of current. |
| Aussie Electrical Stimulation | Experimental | Device: AussieSubjects will receive Aussie electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, a fatigue will be done with this type of current. |
| RBS Electrical Stimulation | Experimental | Device: RBSSubjects will receive RBS electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, a fatigue will be done with this type of current. |
| RBS-IPI Electrical Stimulation | Experimental | Device: RBS-IPISubjects will receive RBS-IPI electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, a fatigue will be done with this type of current. |
| HIFEM | Experimental | Device: HIFEMSubjects will receive HIFEM electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, a fatigue will be done with this type of current. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Male
- Right leg dominant
- Exercising regularly
Key exclusion criteria (6 listed)
- History of injuries in the right leg
- Skin lesions
- Having a pacemaker
- Having a cardiovascular disease.
- Having a neurological disorder.
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 |
|---|---|---|
| Neo-RussianSubjects will receive Neo-Russian electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. | Device | Neo-Russian Electrical Stimulation |
| AussieSubjects will receive Aussie electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. | Device | Aussie Electrical Stimulation |
| RBSSubjects will receive RBS electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. | Device | RBS Electrical Stimulation |
| RBS-IPISubjects will receive RBS-IPI electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. | Device | RBS-IPI Electrical Stimulation |
| HIFEMSubjects will receive HIFEM electrical stimulation with three reps (5 sec work x 60 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. | Device | HIFEM |
Primary outcome
Maximal Voluntary Isometric Contraction (MVIC)
Time frame: Day 1
Force generated by the patient during a maximal voluntary isometric contraction, measured by an isometric dynamometer with load cell and computer interface. The best of the 3 repetitions will be considered. Whenever the third one is the best, additional measurements will be taken until a decrease in torque is obtained in order to determine the maximum. Unit: Newtons (N)
Maximal Electrical Induced Contraction (MEIC)
Time frame: Day 1
Force generated in the muscle while applying electrical stimulation and HIFEM, measured by an isometric dynamometer with load cell and computer interface. This data (in Newtons) will be normalized with the MVIC. Unit: percentage of MVIC
Visual Analogue Scale
Time frame: Day 1
Visual Analogue Scale (VAS): Magnitude of pain, marked in a analogue scale by participants, to determine how unpleasant is each type of stimulation (applied in randomized order). Expresed in centimeters. * Minimum value: 0 * Maximum value: 10 * A higher score implicates a worse outcome. VAS wil be evaluated 5 times, 1 per type of stimulation.
1 secondary outcome
Fatigue index
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neo-Russian, Aussie and RBS in people with Healthy, run by Maimonides University at 1 site in Argentina.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Aug 2022. 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 Argentina. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Ronzio, DHSc PT (+54119051140, ronzio.oscar@maimonides.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Voluntary Isometric Contraction (MVIC) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2022.