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

NCT ID: NCT03258489

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2019-12-09

Brief Summary

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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

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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).

Conditions

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Healthy Volunteers Hypertension, Essential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transcutaneous nervous electric stimulation (TENS)

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.

Group Type ACTIVE_COMPARATOR

Transcutaneous nervous electric stimulation (TENS)

Intervention Type DEVICE

TENS (Frequency 10 Hz or 100Hz /duration 200μs, Endophasys nms 0501® model, KLD Biosystems, Amparo, SP, Brazil) will be applied with intensity between 1 to 60 mA and the current will be adjusted every 5 minutes at the sensory threshold level muscle contraction or according to the tolerance to the stimulus informed by the volunteers. TENS will be applied in bilateral paravertebral region of C7 to T4 or long the brachial plexus and sciatic plexus.

Interferential electrical stimulation (IES)

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.

Group Type ACTIVE_COMPARATOR

Interferential electrical stimulation (IES)

Intervention Type DEVICE

The IES (Endophasys nms 0501®, KLD Biosystems, Amparo, SP, Brazil) will be applied in continuous mode with biphasic pulses. Bipolar electrodes with slope of 1/5/1. The rest of the parameters will be set to 4000 Hz, AMF of 100 Hz and the AMF variation of 25 Hz. The effect of the current will be adjusted by the intensity, it should produce paresthesia stimuli, without pain and below the motor threshold. Adhesive electrodes (MultiStick®, Axelgaard Manufacturing CO, Ltd, Fallbrook, CA, USA) will be housed in the paravertebral region, between C7 (Channel 1) and T4 (Channel 2). (SANTOS et al., 2013)

TENS and IES Placebo

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.

Group Type PLACEBO_COMPARATOR

TENS and IES Placebo

Intervention Type DEVICE

Same protocol without electrical output.

Interventions

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Transcutaneous nervous electric stimulation (TENS)

TENS (Frequency 10 Hz or 100Hz /duration 200μs, Endophasys nms 0501® model, KLD Biosystems, Amparo, SP, Brazil) will be applied with intensity between 1 to 60 mA and the current will be adjusted every 5 minutes at the sensory threshold level muscle contraction or according to the tolerance to the stimulus informed by the volunteers. TENS will be applied in bilateral paravertebral region of C7 to T4 or long the brachial plexus and sciatic plexus.

Intervention Type DEVICE

Interferential electrical stimulation (IES)

The IES (Endophasys nms 0501®, KLD Biosystems, Amparo, SP, Brazil) will be applied in continuous mode with biphasic pulses. Bipolar electrodes with slope of 1/5/1. The rest of the parameters will be set to 4000 Hz, AMF of 100 Hz and the AMF variation of 25 Hz. The effect of the current will be adjusted by the intensity, it should produce paresthesia stimuli, without pain and below the motor threshold. Adhesive electrodes (MultiStick®, Axelgaard Manufacturing CO, Ltd, Fallbrook, CA, USA) will be housed in the paravertebral region, between C7 (Channel 1) and T4 (Channel 2). (SANTOS et al., 2013)

Intervention Type DEVICE

TENS and IES Placebo

Same protocol without electrical output.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Santa Maria

OTHER

Sponsor Role lead

Responsible Party

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Luis Ulisses Signori

Principal Investigador

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luis Ulisses Signori

Santa Maria, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 16672842 (View on PubMed)

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.

Reference Type RESULT
PMID: 23966145 (View on PubMed)

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.

Reference Type RESULT
PMID: 22262107 (View on PubMed)

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.

Reference Type RESULT
PMID: 21827970 (View on PubMed)

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.

Reference Type RESULT
PMID: 23004921 (View on PubMed)

Other Identifiers

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UFSM

Identifier Type: -

Identifier Source: org_study_id