Transcutaneous Electrical Nerve Stimulation on Nervous System in Patients With Hypertension.

Summary

Hypertension has high prevalence and poor control rates and is considered one of the major modifiable risk factors for cardiovascular system diseases, and one of the most important public health problems. The imbalance of the autonomic cardiovascular control, which can be considered as a major etiologic factor in the development of essential hypertension is characterized by increased sympathetic activity and reduced parasympathetic activity possible.

Cardiovascular disease is the leading cause of death and disability in the world and autonomic imbalance is associated with several pathological conditions, and may be a final common pathway for the increased morbidity and mortality of cardiovascular diseases. In this sense, the heart rate variability (HRV) is a quantitative marker of sympathetic and parasympathetic activity, which can be used to assess disease and mortality as a noninvasive technique.

TENS is a noninvasive therapeutic modality, easy to handle, it has no side effects or interactions with medications being used for the relief of pain by sensory stimulation through peripheral nerves and mainly for control and treatment of acute and chronic pain . Research on the effect of TENS on the sympathetic and parasympathetic nervous system activity remain controversial, especially regarding the parameters to use.

The aim of this study is to investigate the effects of TENS on the sympathetic and parasympathetic nervous system in patients with hypertension by heart rate variability and blood pressure variability.

This is a randomized clinical trial, double blind, where hypertensive patients were randomized to three groups: high-frequency TENS (100 Hz) n = 20, low frequency TENS (4 Hz) n = 20 and n = 20 placebo. Evaluations will be made in a single session. The results will be assessed by a blinded investigator and randomization will be done electronically.

It is expected to evaluate how often TENS exerts more influence in the modulation of sympathetic and parasympathetic system.

Conditions

• Cardiovascular Diseases

Interventions

DEVICE

TENS High Frequency

TENS high frequency (100 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.

DEVICE

TENS Low Frequency

TENS low frequency (4 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.

DEVICE

TENS Placebo

TENS was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The placebo group received an active current for 30 seconds, and then gradually decreased for 15 seconds to not pass any current. This approach aims at masking the investigator and subject (RAKEL et al., 2010).

Sponsors & Collaborators

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

  collaborator OTHER_GOV

• Instituto de Cardiologia do Rio Grande do Sul

  collaborator OTHER

• Federal University of Health Science of Porto Alegre

  lead OTHER

Principal Investigators

• Rodrigo DM Plentz, Phd · Federal University of Health Science of Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2015-01-31

Completion

2015-08-31

Countries

• Brazil

Study Locations