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

NCT04200677 | Completed

• 1 other identifier: CAAE: 14734619.3.0000.8093
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Electrical Stimulation

Outcome Measures

Primary Outcomes (6)

• Muscle Fatigue

  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

  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

  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

  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

  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

  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).

Study Arms (9)

MCN1

EXPERIMENTAL

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

BCN05

EXPERIMENTAL

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

BCN1

EXPERIMENTAL

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

BCN2

EXPERIMENTAL

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

MCM1

EXPERIMENTAL

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

BCM05

EXPERIMENTAL

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

BCM1

EXPERIMENTAL

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

BCM2

EXPERIMENTAL

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

BC25

EXPERIMENTAL

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

Interventions

Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve OTHER

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)

MCN1

Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve OTHER

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)

BCN05

Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve OTHER

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)

BCN1

Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve OTHER

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)

BCN2

Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly OTHER

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)

MCM1

Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly OTHER

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)

BCM05

Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly OTHER

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)

BCM1

Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly OTHER

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)

BCM2

Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly OTHER

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)

BC25

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (2)

University of Brasília

Brasília, Federal District, 72220-900, Brazil

Location

Faculty of Physical Education

Brasília, Federal District, Brazil

Location

Related Publications (20)

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• Wegrzyk J, Foure A, Vilmen C, Ghattas B, Maffiuletti NA, Mattei JP, Place N, Bendahan D, Gondin J. Extra Forces induced by wide-pulse, high-frequency electrical stimulation: Occurrence, magnitude, variability and underlying mechanisms. Clin Neurophysiol. 2015 Jul;126(7):1400-12. doi: 10.1016/j.clinph.2014.10.001. Epub 2014 Oct 13.

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Assistant Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 16, 2019
• Study Start: January 10, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

BR (2)