Effects of Kilohertz-frequency and Low-frequency Current on Triceps Surae

May 30, 2023 updated by: University of Brasilia

Effects of Different Modalities of Medium and Low Frequency Electrical Stimulation in the Generation of Evoked Torque, Sensory Discomfort, Muscle Fatigue and Inheritance Peripheral Oxygen Supply in the Triceps Surae Muscle.

Neuromuscular electrical Stimulation (NMES) can minimize muscle atrophy and complications related to muscle disuse and help improve neuromuscular performance. Medium and low-frequency currents have been assessed regarding the generation of evoked torque, sensory discomfort, muscle fatigue, and peripheral oxygen extraction. In addition, metabolic stress is also linked to muscle strength gain, an important aspect to be evaluated in addition to NMES physical parameters. Thus, the aim of this study is to compare the effects of different NMES protocols applied to the triceps surae muscle for evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction in healthy individuals. This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants. All NMES protocols will be tested on the same individual with randomization of the sequence of intervention protocols. There will be a total of 5 encounters with seven days between them. Session 1 will evaluate the anthropometric measures, the maximum intensity for each intervention protocol, and the sequence of intervention protocols for each individual will be randomized. Sessions 2, 3, 4, and 5 will be composed equally with the assessment of the maximum voluntary and evoked joint torque of the triceps surae muscle through the isokinetic dynamometer, evaluation of muscle fatigue through the H-reflex, M-wave, fatigue index, time-torque-integral, and recruitment curve, evaluation of peripheral oxygen extraction through NIRS (Near Infrared Spectroscopy), electromyographic signals to assessed the RMS (root mean square) and the median frequency, evaluation of the level of sensory discomfort through the Visual Analog Pain Scale and finally by the NMES protocol. The EENM protocols will be as follows: CR10% (Russian Current at 2500 Hz, modulated in 50 Hz bursts, 200 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CA10% (Aussie Current with 1000 Hz, modulated in 50 Hz bursts, 500 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CP500 (pulsed current with 50 Hz, 500 µs phase) and CP200 (Pulsed current with 50 Hz, 200 µs phase). all protocols will be performed on the triceps surae muscle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants. The objective is to compare the effects of different NMES protocols applied to the triceps surae muscle for evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction. The effects of the types of neuromuscular electrical stimulation (NMES) protocols on the aforementioned outcomes will be evaluated in the same participant by randomizing the sequences of interventions for each visit in the laboratory. The study is considered double-blind, as individuals will not know the sequence of the protocols applied. The evaluator will also not know which protocol will be used at the time of the intervention. It will consist of a total of 5 sessions with seven days between them. In the first session, anthropometry, the maximum intensity level for each electrical stimulation protocol as well as the protocol sequence for each individual will be evaluated. From the second to the fifth session, the following will be considered: voluntary and evoked maximum joint torque of the triceps surae muscle, muscle fatigue through the evaluation of the H-reflex, M-wave, fatigue index, torque-time-integral and recruitment curve, peripheral oxygen extraction, electromyographic signals through RMS (root mean square) and median frequency, and level of sensory discomfort with the Visual Analog Scale (VAS). From the second to the fifth session will be composed by the following evaluation sequence: warm-up with six submaximal contractions with 6 seconds of duration and 10 seconds of rest between them; then the assessment of muscle fatigue; then two maximal isometric contractions, then two maximal evoked contractions; fatigue protocol at 20% of the maximum isometric contraction (this fatigue protocol will use the NMES sequence randomized in the first session; after the fatigue protocol, two maximum evoked contractions will be performed again; then two maximal isometric contractions and at the end, the muscle fatigue evaluation will be performed again. The NMES protocols will be CR10% (Russian Current at 2500 Hz, modulated in 50 Hz bursts, 200 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CA10% (Aussie Current with 1000 Hz, modulated in 50 Hz bursts, 500 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CP500 (pulsed current with 50 Hz, 500 µs phase) and CP200 (Pulsed current with 50 Hz, 200 µs phase). All protocols will be performed on the triceps surae muscle.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • DF
      • Brasília, DF, Brazil, 72220-275
        • Recruiting
        • Faculty of Ceilandia UnB
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female and male, aged between 18-40 years;
  • Be classified as physically active according to the International Physical Activity Questionnaire (IPAQ);
  • The practice of just recreational physical activity;
  • Achieve a minimum torque of 20% of the MVIC during the NMES;
  • Be at least three months without strength training;

Exclusion Criteria:

  • Present musculoskeletal dysfunction that may interfere with the tests, present intolerance to NMES in the triceps surae muscle;
  • Use analgesics, antidepressants, tranquilizers, or other centrally acting agents;
  • Present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscle disorders that may impair the complete execution of the study design by the volunteer;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Russian current 10%
Subjects will receive a interventions (Russian Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Other: Russian current 10%
Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Other Names:
  • Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Experimental: Aussie current 10%
Subjects will receive a interventions (Aussie Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Other: Aussie current 10%
Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Experimental: Pulsed current 500 µs phase
Subjects will receive a interventions (Pulsed current with 50 Hz, 500 µs phase). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Other: Pulsed current 500 µs phase
Pulsed current, modulated in 50 Hz, 500 µs
Experimental: Pulsed current 200 µs phase
Subjects will receive a interventions (Pulsed current with 50 Hz, 200 µs phase). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Other: Pulsed current 200 µs phase
Pulsed current, modulated in 50 Hz, 200 µs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Submaximal voluntary isometric contraction of the triceps surae
Time Frame: 2 minutes
Expressed in muscle strength, assessed using an isokinetic dynamometer
2 minutes
Maximum voluntary isometric contraction of the triceps surae
Time Frame: 5 minutes
Expressed in muscle strength, assessed using an isokinetic dynamometer
5 minutes
Maximum evoked torque
Time Frame: 5 minutes
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
5 minutes
Muscle fatigue assessment before the muscle fatigue protocol
Time Frame: 10 minutes
Expressed by mechanical properties of plantar flexors and central activation relationship using the contraction interpolation technique
10 minutes
Assessment of muscle fatigue during the muscle fatigue protocol
Time Frame: 20 minutes
Expressed by the muscle fatigue index through the decline in torque evoked from the beginning to the end of the protocol
20 minutes
Muscle fatigue assessment during the muscle fatigue protocol
Time Frame: 20 minutes
Expressed by the decline in torque-time-integral from the beginning to the end of the protocol
20 minutes
Torque evoked during the fatigue protocol
Time Frame: 15 minutes
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral oxygen extraction
Time Frame: 40 minutes
Expressed by peripheral oxygen consumption assessed by near-infrared spectroscopy from the beginning to the end of the sessions
40 minutes
Electromyographic signals
Time Frame: 40 minutes
Expressed by the raw values of RMS and Median Frequency within a range of 500 ms throughout the entire session
40 minutes
Sensory discomfort during maximum evoked torques
Time Frame: 10 seconds
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort
10 seconds
Sensory discomfort during fatigue protocol
Time Frame: 10 seconds
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort
10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Investigators

  • Principal Investigator: João LQ Durigan, PhD, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

May 22, 2024

Study Completion (Estimated)

May 22, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 67915523.1.0000.8093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The authors consider sharing the data depending on the situation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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