Clinical trial NCT03258489: Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
Official title: Effects of Transcutaneous Nervous Electric Stimulation (TENS) and Interferential Electrical Stimulation (IES) on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Hypertension, Essential
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypertension is considered a serious public health problem. The imbalance in autonomic nervous system (ANS) activity is one of the main triggers in the development and maintenance of hypertension. The non-pharmacological management of this disease is an important resource, especially in refractory hypertensive patients or in hypertensive crises, where the pharmacological treatment does not present an efficient response. It is known that transcutaneous electrical nerve stimulation (TENS) is capable of modifying the autonomic balance, however, the effects of Interferential electrical stimulation (IES) on this system in normotensive and hypertensive volunteers are not yet known. These electrotherapeutic resources may be a non-pharmacological tool supporting the management of hypertension. The objective of this research is to study the effects of different TENS and IC parameters on cardiovascular variables of normotensive volunteers and hypertensive patients.

Detailed description: Each volunteer will perform three assessments with a one-week interval. Each assessment will include assessment of autonomic balance, blood pressure, and blood collection (catecholamines). Interventions (placebo, low frequency TENS and IES) will be randomized. Volunteers will be accommodated in the supine position. With properly sanitized skin (70% alcohol) and self-adhesive electrodes (5x5 area) will be positioned in the cervical paravertebral region. All participants will be submitted to a placebo TENS session, a low frequency TENS session (TENS, 10 Hz/200μs) and an IES session (STEIN et al., 2012). The sessions will take place in the morning in a 12-hour fast, lasting 30 minutes, in an air-conditioned place (23ºC).

Eligibility criteria: Inclusion Criteria:

* Both sexes;
* Normal blood pressure (PAS \<130 mmHg; PAD \<85 mmHg) or Previous Hypertension diagnosis, systolic blood pressure (SBP) \> 140 mm Hg and/or diastolic blood pressure (DBP) \>90 mm Hg and clinical stability with no change in medications for at least 2 months preceding the study;
* The subjects that joined the study will be alphabetized volunteers;
* Age between 20 and 65 years old;
* With no symptoms of skeletal muscle disorders;
* No previous performing cardiovascular surgery;
* No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases;
* Without evidence of psychiatric diseases and/or cognitive déficit;
* Non-Smoker;
* Volunteers with a body mass index (BMI: kg/m2) greater than 35 will not be included in the study

Exclusion Criteria:

* On the day of the assessments who have consumed of the alcoholic drink, caffeine and citrus juice and who have performed intense physical activities 48 before the examination

Primary outcomes:
measure: Systemic arterial pressure (mmHg)
timeFrame: SBP will be evaluated 1 hours after the interventions
Secondary outcomes:
measure: Blood collection - catecholamines (pg/mL)
timeFrame: Blood collection (catecholamines) will be evaluated 1 hours after the interventions
measure: Heart Rate Variability (n.u.)
timeFrame: HRV will be evaluated 1 hours after the interventions
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Luis Ulisses Signori
state: Rio Grande Do Sul
Study officials:
References:
citation: Gamelin FX, Berthoin S, Bosquet L. Validity of the polar S810 heart rate monitor to measure R-R intervals at rest. Med Sci Sports Exerc. 2006 May;38(5):887-93. doi: 10.1249/01.mss.0000218135.79476.9c.
citation: Santos FV, Chiappa GR, Vieira PJ, Umpierre D, Ribeiro JP, Cipriano G Jr. Interferential electrical stimulation improves peripheral vasodilatation in healthy individuals. Braz J Phys Ther. 2013 May-Jun;17(3):281-8. doi: 10.1590/s1413-35552012005000092.
citation: Sociedade Brasileira de Cardiologia (SBC); Sociedade Brasileira de Hipertensao (SBH); Sociedade Brasileira de Nefrologia (SBN). [V Guidelines for ambulatory blood pressure monitoring (ABPM) and III Guidelines for home blood pressure monitoring (HBPM)]. Arq Bras Cardiol. 2011 Sep;97(3 Suppl 3):1-24. No abstract available. Portuguese.
citation: Stein C, Dal Lago P, Ferreira JB, Casali KR, Plentz RD. Transcutaneous electrical nerve stimulation at different frequencies on heart rate variability in healthy subjects. Auton Neurosci. 2011 Dec 7;165(2):205-8. doi: 10.1016/j.autneu.2011.07.003. Epub 2011 Aug 9.
citation: Stein C, Mea Plentz RD. The effect of transcutaneous electrical nerve stimulation on blood pressure. Blood Press. 2013 Jun;22(3):188-9. doi: 10.3109/08037051.2012.722271. Epub 2012 Sep 25. No abstract available.