- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03258489
Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
December 9, 2019 updated by: Luis Ulisses Signori, Universidade Federal de Santa Maria
Effects of Transcutaneous Nervous Electric Stimulation (TENS) and Interferential Electrical Stimulation (IES) on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
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.
Study Overview
Status
Completed
Conditions
Detailed 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).
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rio Grande Do Sul
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Santa Maria, Rio Grande Do Sul, Brazil, 5596200190
- Luis Ulisses Signori
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
|
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.
|
ACTIVE_COMPARATOR: 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.
|
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)
|
PLACEBO_COMPARATOR: 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.
|
Same protocol without electrical output.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic arterial pressure (mmHg)
Time Frame: SBP will be evaluated 1 hours after the interventions
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood collection - catecholamines (pg/mL)
Time Frame: Blood collection (catecholamines) will be evaluated 1 hours after the interventions
|
Plasma levels of catecholamines (dopamine, epinephrine and norepinephrine) will be evaluated before and after HPLC (High Performance Liquid Chromatography) interventions.
Blood with heparin will be homogenized and immediately transferred to a special tube containing 120 μL of EGTA/GSH (reduced glutathione) solution.
After being centrifuged and the plasma transferred to a plastic tube, it is placed in a freezer (-80ºC).
|
Blood collection (catecholamines) will be evaluated 1 hours after the interventions
|
Heart Rate Variability (n.u.)
Time Frame: HRV will be evaluated 1 hours after the interventions
|
The autonomic balance evaluate by heart rate variability (HRV) and the heart rate signal will be purchased through a pulse frequency meter mark Polar model 810i (GAMELIN et al., 2006).
The acquisition of ECG signal (sample rate-1 kHz) of the time series of RR will be purchased in continuous intervals (10 min).
Data Will be transferred to a computer and RR intervals.
They will be processed to calculate HRV parameter using the HRV analysis software KUBIOS.
HRV will be analyzed in the time and frequency domain, using the area of greatest stability in RR intervals corresponding to 5 min of recordings (containing at least 256 consecutive beats) during controlled breathing.
Volunteers Will remain in a supine position at rest for 10 min and afterwards, data will be collected with controlled breathing (12 breaths per minute; I/E:2/3) (STEIN et al., 2011).
Values expressed in Total Power (ms2) and normalization unit (n.u.) (GAMELIN et al., 2006).
|
HRV will be evaluated 1 hours after the interventions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 20, 2018
Primary Completion (ACTUAL)
December 9, 2019
Study Completion (ACTUAL)
December 9, 2019
Study Registration Dates
First Submitted
July 26, 2017
First Submitted That Met QC Criteria
August 18, 2017
First Posted (ACTUAL)
August 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFSM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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