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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894044
• Other study ID #: 67915523.1.0000.8093
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: May 22, 2024

Study information

• Verified date: May 2023
• Source: University of Brasilia
• Contact: João LQ Durigan, PhD
• Phone: 61 3107-8450
• Email: joaodurigan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 22, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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
• Pulsed current 500 µs phase
Pulsed current, modulated in 50 Hz, 500 µs
• Pulsed current 200 µs phase
Pulsed current, modulated in 50 Hz, 200 µs

Locations

Country	Name	City	State
Brazil	Faculty of Ceilandia UnB	Brasília	DF

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View Citation

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. — View Citation

Baldi JC, Jackson RD, Moraille R, Mysiw WJ. Muscle atrophy is prevented in patients with acute spinal cord injury using functional electrical stimulation. Spinal Cord. 1998 Jul;36(7):463-9. doi: 10.1038/sj.sc.3100679. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Submaximal voluntary isometric contraction of the triceps surae	Expressed in muscle strength, assessed using an isokinetic dynamometer	2 minutes
Primary	Maximum voluntary isometric contraction of the triceps surae	Expressed in muscle strength, assessed using an isokinetic dynamometer	5 minutes
Primary	Maximum evoked torque	Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer	5 minutes
Primary	Torque evoked during the fatigue protocol	Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer	15 minutes
Primary	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
Primary	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
Primary	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	Sensory discomfort during maximum evoked torques	Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort	10 seconds
Secondary	Sensory discomfort during fatigue protocol	Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort	10 seconds
Secondary	Electromyographic signals	Expressed by the raw values of RMS and Median Frequency within a range of 500 ms throughout the entire session	40 minutes
Secondary	Peripheral oxygen extraction	Expressed by peripheral oxygen consumption assessed by near-infrared spectroscopy from the beginning to the end of the sessions	40 minutes