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

NCT03258489 | Completed

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

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.

Conditions

Healthy Volunteers; Hypertension, Essential

Outcome Measures

Primary Outcomes (1)

• Systemic arterial pressure (mmHg)

  Systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) (NOBRE et al., 2011). Micromed and version 5.0.1.52 equipment will be used. Blood pressure monitoring using ABPM will be performed every 10 min throughout the experiment, which has an estimated time of two hours.

  SBP will be evaluated 1 hours after the interventions

Secondary Outcomes (2)

• Blood collection - catecholamines (pg/mL)

  Blood collection (catecholamines) will be evaluated 1 hours after the interventions

• Heart Rate Variability (n.u.)

  HRV will be evaluated 1 hours after the interventions

Study Arms (3)

Transcutaneous nervous electric stimulation (TENS)

ACTIVE COMPARATOR

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.

Device: Transcutaneous nervous electric stimulation (TENS)

Interferential electrical stimulation (IES)

ACTIVE COMPARATOR

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.

Device: Interferential electrical stimulation (IES)

TENS and IES Placebo

PLACEBO COMPARATOR

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.

Device: TENS and IES Placebo

Interventions

Transcutaneous nervous electric stimulation (TENS) 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.

Transcutaneous nervous electric stimulation (TENS)

Interferential electrical stimulation (IES) 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)

Interferential electrical stimulation (IES)

TENS and IES Placebo DEVICE

Same protocol without electrical output.

TENS and IES Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Luis Ulisses Signori

Santa Maria, Rio Grande do Sul, 5596200190, Brazil

Location

Related Publications (5)

• 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.

  PMID: 16672842 RESULT

• 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.

  PMID: 23966145 RESULT

• 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.

  PMID: 22262107 RESULT

• 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.

  PMID: 21827970 RESULT

• 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.

  PMID: 23004921 RESULT

MeSH Terms

Conditions

Essential Hypertension

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 23, 2017
• Study Start: July 20, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

BR (1)