Influence of Electrode Positioning and Current Type on Fatigue, Force and Discomfort

May 23, 2023 updated by: João Luiz Q. Durigan, University of Brasilia

Influence of Electrode Positioning and Current Type on Muscle Fatigability, Force Generation, Perceived Discomfort and Neuromuscular Adaptations Induced by Neuromuscular Electric Stimulation: Implications on Rehabilitation

Introduction: Neuromuscular electrical stimulation (NMES) has the purpose of generating muscle contractions to minimize muscular atrophy and to improve neuromuscular performance. NMES has been performed using monophasic or biphasic currents, applied over a nerve trunk or muscle belly, and both can generate contractions by the peripheral and central nervous system. Pulse width (wide or narrow) is an essential parameter for NMES. Although NMES studies using wide pulses have been performed with monophasic currents, it is known that this current induces discomfort during NMES. Therefore, it is necessary to analyze if biphasic currents have the same effect as monophasic currents using the same parameters.

Objectives:

To compare the effects of NMES with narrow and wide pulse widths associated with monophasic and biphasic currents, applied over a tibial nerve and triceps surae muscles in healthy individuals in terms of muscle fatigue, central and peripheral contribution, voluntary and evoked force and sensory discomfort.

Methods:

A crossover, experimental controlled and randomized study will be developed with healthy male and female (age: 18-45 years). The following dependent variables will be: amplitude of H-reflex and M-wave (single and double pulses), voluntary and evoked triceps surae muscles torque, fatigability (force time integral), perceived discomfort and neuromuscular adaptations. The independent variables will be related to current phase, pulse width and location of electrical stimulation electrodes. There will be a familiarization session followed by 9 sessions with 7 rest days between them (10 weeks). Data will be reported as mean and standard deviation (± SD). Parametric tests will be used for the normally distributed data (Shapiro-Wilk test) that show homogeneous variations (Levene test). A repeated measure mixed-model ANOVA will be performed and, in the case of major effects or significant interactions, the Tukey post-hoc test will be applied. In addition, the power and size of the effect (reported as partial eta square, partial η2) will be calculated. The significance threshold will be set at p <0.05 for all procedures.

Expected results: Biphasic currents will be more comfortable and will generate less muscle fatigue when compared to monophasic currents. There will be less fatigue and greater central contribution when wider pulse currents will be applied over a nerve trunk concerning the application with a wide pulse over a muscle belly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial, a crossover study, with healthy male and female participants. The procedures will take place in 10 distinct visits for a 7-day interval.

The following visit in the lab will be:

  • Familiarization session.
  • Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve;
  • Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve;
  • Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve;
  • Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve;
  • Monophasic (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly;
  • Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly;
  • Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly;
  • Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly;
  • Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly.

The dependent variables will be:

  • Muscle fatigability;
  • Central and peripheral contribution (with H-reflex and M-wave amplitude analysis);
  • Maximum voluntary isometric contraction;
  • Force production for plantar flexion evoked by NMES;
  • Perceived discomfort.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Brazil
    • DF
      • Brasília, DF, Brazil, 72220-900
        • University of Brasilia
      • Brasília, DF, Brazil
        • Faculty of Physical Education

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY;
  • To practice only recreational physical activity;
  • Be at least 3 months without practicing strength training.

Exclusion Criteria:

  • Present some type of skeletal muscle dysfunction that may interfere with the tests;
  • NMES intolerance in the triceps surae muscle belly or tibial nerve;
  • Use of analgesics, antidepressants, tranquilizers or other centrally acting agents;
  • Cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular disorders that may hinder 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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCN1
Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve
Other: Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following NMES parameters: (Monophasic Current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Experimental: BCN05
Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve
Other: Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
Experimental: BCN1
Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve
Other: Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Experimental: BCN2
Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve
Other: Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s)
Experimental: MCM1
Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly
Other: Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Monophasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Experimental: BCM05
Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly
Other: Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
Experimental: BCM1
Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly
Other: Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Experimental: BCM2
Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly
Other: Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s)
Experimental: BC25
Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly
Other: Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 25 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Fatigue
Time Frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Muscle Fatigue will be assessed by Force time integral (area under the force trace), after neuromuscular electrical stimulation protocol.
Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Muscle Force
Time Frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Muscle force will be assessed by muscle force changes, based on the torque generated pre and post neuromuscular electrical stimulation protocol.
Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Change from Baseline Central contribution (H reflex amplitude) after 15 minutes session of NMES
Time Frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the session.
Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Change from Baseline Peripheral contribution (M wave amplitude) after 15 minutes session of NMES
Time Frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the session.
Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Change from Baseline Evoked Torque after 15 minutes session of electrical stimulation
Time Frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Evoked Torque will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the session.
Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Discomfort
Time Frame: At the beginning, middle and end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Discomfort sensory will be evaluated by Visual Analogic Scale during and after the evoked torque measurement with NMES. The Visual Analogic Scale assess pain by rating the subjective perceived discomfort of the subject from 0 (no perceived discomfort) to 10 (the most perceived discomfort)
At the beginning, middle and end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).

Collaborators and Investigators

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

Sponsor

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)

January 10, 2020

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CAAE: 14734619.3.0000.8093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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