Healthy VolunteersNCT03258489
Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
A study testing Transcutaneous nervous electric stimulation (TENS) and Interferential electrical stimulation (IES) in people with Healthy Volunteers and Hypertension, Essential, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hypertension, Essential
- What is being tested?
- Transcutaneous nervous electric stimulation (TENS) and Interferential electrical stimulation (IES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2018to 9 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy Volunteers, Hypertension, Essential
- Being tested
- Transcutaneous nervous electric stimulation (TENS), Interferential electrical stimulation (IES), TENS and IES Placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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)
TENS and IES PlaceboDevice
Same protocol without electrical output.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: TENS and IES Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: SBP will be evaluated 1 hours after the interventions
Secondary outcomes (2)
Blood collection - catecholamines (pg/mL)
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).
Measured: Blood collection (catecholamines) will be evaluated 1 hours after the interventions
Heart Rate Variability (n.u.)
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).
Measured: HRV will be evaluated 1 hours after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start20 Jul 2018
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Ulisses Signori, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258489
- Sponsor's protocol ID
- UFSM
- Status last verified
- Dec 2019
- First submitted
- 26 Jul 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 16672842Santos 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.
PubMed 23966145Sociedade 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.
PubMed 22262107Stein 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.
PubMed 21827970Stein 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.
PubMed 23004921
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Nervous Electric Stimulation (TENS) and Interferential Electrical Stimulation (IES) on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03258489
- Acronym / sponsor ID
- UFSM
- Conditions
- Healthy Volunteers, Hypertension, Essential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous nervous electric stimulation (TENS) | Active comparator | Device: 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. |
| Interferential electrical stimulation (IES) | Active comparator | Device: 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. |
| TENS and IES Placebo | Placebo comparator | Device: TENS and IES PlaceboAutonomic 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcutaneous nervous electric stimulation (TENS) |
| 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) | Device | Interferential electrical stimulation (IES) |
| TENS and IES PlaceboSame protocol without electrical output. | Device | TENS and IES Placebo |
Primary outcome
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.
2 secondary outcomes
Blood collection - catecholamines (pg/mL)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Results publication: PubMed 16672842Gamelin 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.
- Results publication: PubMed 23966145Santos 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.
- Results publication: PubMed 22262107Sociedade 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.
- Results publication: PubMed 21827970Stein 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.
- Results publication: PubMed 23004921Stein 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous nervous electric stimulation (TENS) and Interferential electrical stimulation (IES) in people with Healthy Volunteers and Hypertension, Essential, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic arterial pressure (mmHg) (time frame: SBP will be evaluated 1 hours after the interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258489, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.