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

NCT05894044 | Unknown DMC

• 1 other identifier: 67915523.1.0000.8093
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Electrical stimulation; Burst; M-wave; H-reflex; Pulsed current; Russian current; Aussie Current

Outcome Measures

Primary Outcomes (7)

• Submaximal voluntary isometric contraction of the triceps surae

  Expressed in muscle strength, assessed using an isokinetic dynamometer

  2 minutes

• Maximum voluntary isometric contraction of the triceps surae

  Expressed in muscle strength, assessed using an isokinetic dynamometer

  5 minutes

• Maximum evoked torque

  Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer

  5 minutes

• Torque evoked during the fatigue protocol

  Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer

  15 minutes

• Muscle fatigue assessment before the muscle fatigue protocol

  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

  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

  Expressed by the decline in torque-time-integral from the beginning to the end of the protocol

  20 minutes

Secondary Outcomes (4)

• Sensory discomfort during maximum evoked torques

  10 seconds

• Sensory discomfort during fatigue protocol

  10 seconds

• Electromyographic signals

  40 minutes

• Peripheral oxygen extraction

  40 minutes

Study Arms (4)

Russian current 10%

EXPERIMENTAL

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%

Aussie current 10%

EXPERIMENTAL

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%

Pulsed current 500 µs phase

EXPERIMENTAL

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 200 µs phase

EXPERIMENTAL

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

Interventions

Russian current 10% OTHER

Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts

Also known as: Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts

Russian current 10%

Aussie current 10% OTHER

Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts

Aussie current 10%

Pulsed current 500 µs phase OTHER

Pulsed current, modulated in 50 Hz, 500 µs

Pulsed current 500 µs phase

Pulsed current 200 µs phase OTHER

Pulsed current, modulated in 50 Hz, 200 µs

Pulsed current 200 µs phase

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Faculty of Ceilandia UnB

Brasília, Federal District, 72220-275, Brazil

RECRUITING

Related Publications (9)

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  PMID: 9670381 BACKGROUND

• Ward AR, Lucas-Toumbourou S, McCarthy B. A comparison of the analgesic efficacy of medium-frequency alternating current and TENS. Physiotherapy. 2009 Dec;95(4):280-8. doi: 10.1016/j.physio.2009.06.005. Epub 2009 Sep 2.

  PMID: 19892092 BACKGROUND

• Aldayel A, Jubeau M, McGuigan M, Nosaka K. Comparison between alternating and pulsed current electrical muscle stimulation for muscle and systemic acute responses. J Appl Physiol (1985). 2010 Sep;109(3):735-44. doi: 10.1152/japplphysiol.00189.2010. Epub 2010 Jul 1.

  PMID: 20595542 BACKGROUND

• Arpin DJ, Forrest G, Harkema SJ, Rejc E. Submaximal Marker for Investigating Peak Muscle Torque Using Neuromuscular Electrical Stimulation after Paralysis. J Neurotrauma. 2019 Mar 19;36(6):930-936. doi: 10.1089/neu.2018.5848. Epub 2018 Nov 16.

  PMID: 30226407 BACKGROUND

• Martin A, Grospretre S, Vilmen C, Guye M, Mattei JP, LE Fur Y, Bendahan D, Gondin J. The Etiology of Muscle Fatigue Differs between Two Electrical Stimulation Protocols. Med Sci Sports Exerc. 2016 Aug;48(8):1474-84. doi: 10.1249/MSS.0000000000000930.

  PMID: 27031743 BACKGROUND

• Neyroud D, Dodd D, Gondin J, Maffiuletti NA, Kayser B, Place N. Wide-pulse-high-frequency neuromuscular stimulation of triceps surae induces greater muscle fatigue compared with conventional stimulation. J Appl Physiol (1985). 2014 May 15;116(10):1281-9. doi: 10.1152/japplphysiol.01015.2013. Epub 2014 Mar 27.

  PMID: 24674861 BACKGROUND

• Pinto Damo NL, Modesto KA, Neto IVS, Bottaro M, Babault N, Durigan JLQ. Effects of different electrical stimulation currents and phase durations on submaximal and maximum torque, efficiency, and discomfort: a randomized crossover trial. Braz J Phys Ther. 2021 Sep-Oct;25(5):593-600. doi: 10.1016/j.bjpt.2021.03.001. Epub 2021 Mar 26.

  PMID: 33840592 BACKGROUND

• da Silva VZ, Durigan JL, Arena R, de Noronha M, Gurney B, Cipriano G Jr. Current evidence demonstrates similar effects of kilohertz-frequency and low-frequency current on quadriceps evoked torque and discomfort in healthy individuals: a systematic review with meta-analysis. Physiother Theory Pract. 2015;31(8):533-9. doi: 10.3109/09593985.2015.1064191. Epub 2015 Oct 14.

  PMID: 26467544 BACKGROUND

• Bellew JW, Cayot T, Brown K, Blair C, Dishion T, Ortman B, Reel A. Changes in microvascular oxygenation and total hemoglobin concentration of the vastus lateralis during neuromuscular electrical stimulation (NMES). Physiother Theory Pract. 2021 Aug;37(8):926-934. doi: 10.1080/09593985.2019.1652945. Epub 2019 Aug 12.

  PMID: 31402741 BACKGROUND

Study Officials

• João LQ Durigan, PhD

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João LQ Durigan, PhD

CONTACT

61 3107-8450; joaodurigan@gmail.com

Luis AO Soares, Graduate

CONTACT

61 3107-8450; luisandreoliveirasoares@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: May 23, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)