Electrical Stimulation With Different Currents and Electromagnetic Fields

NCT ID: NCT05500300

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2022-12-01

Brief 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). 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Neo-Russian Electrical Stimulation

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.

Group Type: EXPERIMENTAL

Neo-Russian

Intervention Type: DEVICE

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.

Aussie Electrical Stimulation

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.

Group Type: EXPERIMENTAL

Aussie

Intervention Type: DEVICE

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.

RBS Electrical Stimulation

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.

Group Type: EXPERIMENTAL

RBS

Intervention Type: DEVICE

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-IPI Electrical Stimulation

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.

Group Type: EXPERIMENTAL

RBS-IPI

Intervention Type: DEVICE

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.

HIFEM

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.

Group Type: EXPERIMENTAL

HIFEM

Intervention Type: DEVICE

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.

Interventions

Neo-Russian

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.

Intervention Type: DEVICE

Aussie

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.

Intervention Type: DEVICE

RBS

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.

Intervention Type: DEVICE

RBS-IPI

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.

Intervention Type: DEVICE

HIFEM

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Male
• Right leg dominant
• Exercising regularly

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maimonides University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maimonides University

Buenos Aires, Buenos Aires F.D., Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Oscar Ronzio, DHSc PT

Role: CONTACT

ronzio.oscar@maimonides.edu

+54119051140

Facility Contacts

Oscar Ronzio, DHSc

Role: primary

ronzio.oscar@maimonides.edu

+541149051140

Other Identifiers

5891

Identifier Type: -

Identifier Source: org_study_id