Title:	Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals : study protocol for a randomized controlled trial
Authors:	Vilela-Martin, José Fernando Giollo-Junior, Luiz Tadeu Chiappa, Gaspar Rogério Cipriano Junior, Gerson Vieira, Paulo José Cardoso Ricardi, Fábio dos Santos Ricardi Paz-Landim, Manoel Ildefonso Andrade, Days Oliveira de Cesário, Elizabeth do Espírito Santo Consenso-Martin, Luciana Neves Yugar-Toledo, Juan Carlos Cipullo, José Paulo
Assunto::	Sistema nervoso simpático Pressão arterial Hipertensão Estimulação elétrica transcutânea do nervo
Issue Date:	2016
Publisher:	Biomed Central
Citation:	ViLELA-MARTIN, José Fernando et al. Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial. Trials, v. 17, 168, 2016. DOI: https://doi.org/10.1186/s13063-016-1302-8. Disponível em: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1302-8. Acesso em: 17 maio 2021.
Abstract:	Background: Resistant hypertension (RH) treatment requires an adequate and intense therapeutic approach. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of RH, sympathetic overstimulation and therapies that block the sympathetic system have been widely studied. These approaches, however, are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a noninvasive method that modulates activity by using low-frequency transcutaneous electrical stimulation to inhibit primary afferent pathways. Thus, the current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with RH and will seek to develop a new low-cost and readily available therapy to treat this group of hypertensive individuals. Methods/design: This is a randomized, single blind (subject), parallel-assignment study controlled with a sham group and including participants aged 40 to 70 years with resistant hypertension. The trial has two arms: the treatment and control (sham group). The treatment group will be submitted to the stimulation procedure (TENS). The sham group will not be submitted to stimulation. The primary outcomes will be a reduction in the peripheral blood pressure and adverse events. The secondary outcomes will be a reduction the central blood pressure. The study will last 30 days. The sample size was calculated assuming an alpha error of 5 % to reject the null hypothesis with a statistical power of 80 %, thereby resulting in 28 participants per group (intervention versus sham). Discussion: In recent decades, RH has become very common and costly. Adequate control requires several drugs, and in many cases, treatment is not successful. Sympathetic nervous system inhibition by renal denervation and central inhibition have significant effects in reducing BP; however, these treatments are costly and invasive. Another type of sympathetic nervous system inhibition can also be noninvasively achieved by electric current. Therefore, the application of TENS may be a new therapeutic option for treating resistant hypertensive individuals. Trial Registration: Clinical Trials NCT02365974
Licença::	(CC BY) - © 2016 Vilela-Martin et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
DOI:	https://doi.org/10.1186/s13063-016-1302-8
Appears in Collections:	Artigos publicados em periódicos e afins

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