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

NCT02292199 | Unknown DMC

• 1 other identifier: HYPERTENSIONTENS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypertension; TENS; Sympathetic and Parasympathetic nervous system

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  For the analysis of heart rate variability (HRV), the time of RR intervals obtained from continuous ECG signal recorded by Finapres device (Ohmeda 2300, Colorado, USA) series. The time series of RR will be analyzed in the time and frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD). The acquisition of electrocardiogram signal (ECG) was performed immediately before and after the interventions for a 10-minute period, with the subject at rest.

  2 Hours

Study Arms (3)

TENS High Frequency 100 Hz

EXPERIMENTAL

TENS was applied for thirty minutes, with the frequency defined according to randomization. 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 High Frequency

TENS Low Frequency 4 Hz

ACTIVE COMPARATOR

TENS was applied for thirty minutes, with the frequency defined according to randomization. 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 Placebo

PLACEBO COMPARATOR

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).

Device: TENS Placebo

Interventions

TENS High Frequency DEVICE

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.

TENS High Frequency 100 Hz

TENS Low Frequency DEVICE

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.

TENS Low Frequency 4 Hz

TENS Placebo DEVICE

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).

TENS Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of any comorbidity such as diabetes; congestive heart failure; unstable angina; myocardial infarction; acute inflammation; peripheral vascular disease; associated neurological disease; acute respiratory illness; infectious disease or fever; cardiac pacemaker; unstable ventricular arrhythmia; active smokers; obesity; musculoskeletal disease in the lower limbs; changes in the electrocardiogram; smoker; treatment with beta blockers, steroids, hormones or chemotherapy or change in drug therapy were excluded from the study.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Instituto de Cardiologia do Rio Grande do Sul: collaborator

Study Sites (1)

Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Rodrigo DM Plentz, Phd

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo DM Plentz, Phd

CONTACT

+55(51)9179-4399; roplentz@yahoo.com.br

Sandra A Sartori, Graduated

CONTACT

+55(51) 9949-6180; sandrasartorirs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of transcutaneous electrical nerve stimulation on sympathetic and parasympathetic nervous system in patients with hypertension: a randomized clinical trial

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

BR (1)