Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial

Abstract

BackgroundResistant 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/designThis 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).DiscussionIn 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 RegistrationClinical Trials NCT02365974Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1302-8) contains supplementary material, which is available to authorized users.

<p>The potential role of testosterone in hypertension and target organ damage in hypertensive postmenopausal women</p>

“…Clinical characteristics, such as height, weight, BMI,30 BP, history of hypertension, family history, anti-hypertensive medication use, and other metabolic indices, were collected.…”

The Effect of Transcutaneous Electrical Nerve Stimulation in Peripheral and Central Hemodynamic Parameters on Resistant Hypertension: A Case Report

“…Due to the high incidence of cardiovascular morbidity and mortality caused by RH, we have proposed a study with a more effective, highly specific, and non-invasive therapeutic approach that is reproducible and less costly from a financial point of view. 35 …”

A new use of transcutaneous electrical nerve stimulation: Role of bioelectric technology in resistant hypertension (Review)

“…More attention needs to be paid to the study of TENS in RH. A more comprehensive clinical trial design has been registered with the US Clinical Trials Center ( 52 ). Future research and development are needed to evaluate the mechanism and effectiveness of TENS in the treatment of RH.…”

“…However, medication side effects, poor adherence to treatment and difficulty in adhering to lifestyle changes limit BP control to target values in patients with RH. Due to the target organ damage and the autonomic imbalance, RH has become common and costly ( 2 ). In recent years, there has been an increasing emphasis on complementary and alternative treatments without medication.…”