Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients

Universidade Federal de Santa Maria

Status: Completed

Conditions: Healthy Volunteers; Hypertension, Essential

Treatments: Device: Transcutaneous nervous electric stimulation (TENS); Device: TENS and IES Placebo; Device: Interferential electrical stimulation (IES)

Study type: Interventional

Funder types: Other

Identifiers

NCT03258489

UFSM

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Transcutaneous nervous electric stimulation (TENS)

Active Comparator group

Description:

Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after TENS. The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.

Treatment:

Device: Transcutaneous nervous electric stimulation (TENS)

Interferential electrical stimulation (IES)

Active Comparator group

Description:

Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after Interferential electrical stimulation (IES). The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.

Treatment:

Device: Interferential electrical stimulation (IES)

TENS and IES Placebo

Placebo Comparator group

Description:

Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after of the TENS and IES placebo. The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.

Treatment:

Device: TENS and IES Placebo