Electrical Stimulation With Different Currents and Electromagnetic Fields

Healthy Clinical Trial

Official title:

Effects on Isometric Force Induction, Tolerance and Fatigue of Neuromuscular Electrical Stimulation and High Intensity Focused Electromagnetic Field in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500300
• Other study ID #: 5891
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: Maimonides University
• Contact: Oscar Ronzio, DHSc PT
• Phone: +54119051140
• Email: ronzio.oscar[@]maimonides.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Argentina	Maimonides University	Ciudad Autonoma de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides University

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 1
Primary	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	Day 1
Primary	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.	Day 1
Secondary	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.	Day 7