HypertensionTENSNCT02365974
Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure
A study testing Transcutaneous Electrical Stimulation and No Transcutaneous Electrical Stimulation in people with Hypertension and Vascular Stiffness, run by Hospital de Base.
Trial summary
Uncontrolled blood pressure represents the main factor in the development of target organ lesions and, consequently, cardiovascular events, which are the leading cause of morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension, Vascular Stiffness, Autonomic Nervous System Diseases
- What is being tested?
- Transcutaneous Electrical Stimulation and No Transcutaneous Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to Jun 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RH patients taking at least three antihypertensive drugs at full doses, one of which is preferably a thiazide diuretic; Age between 40 and 70 years.
Who cannot join
- Use of a cardiac pacemaker
- Cardiac electrical conduction abnormalities evidenced by ECG or stress test (ergometry)
- Dermatological abnormalities at the site of the application of TENS
- Uncontrolled diabetes patients using oral hypoglycemic agents or insulin with glycated Hb ≥ 7.5%
- Secondary Hypertension
- Patients who do not adhere to the lifestyle changes recommended by their physician such as low-sodium diet and weight loss
- Moderate to severe cervical-thoracic scoliosis
- Obesity with body mass index (BMI) ≥35 kg/m2
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure in Resistant Hypertensive Individuals
Uncontrolled blood pressure represents the main factor in the development of target organ lesions and, consequently, cardiovascular events, which are the leading cause of morbidity and mortality worldwide. In most cases resistant hypertension is preceded by target organ lesions, and is strongly influenced by risk factors or associated diseases. To control this disease requires an adequate and intense therapeutic approach that includes lifestyle changes and the use of several antihypertensive drugs. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of resistant hypertension (RH), two, sympathetic overstimulation and therapies that block the sympathetic system, have been widely studied. But, these approaches are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a non-invasive method that modulates activity by inhibiting primary afferent pathways using low-frequency transcutaneous electrical stimulation. Some studies have shown that TENS reduces blood pressure in patients with hypertension. The current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low cost and readily available therapy to treat this group of hypertensive individuals.
Read the detailed description
Patients will be divided into two groups: treatment and control (sham group). The sham group will be submitted to the procedure to fit the stimulation equipment. However, these patients will not be submitted to stimulation. Both groups will undergo a physical examination at the start and end of the study period to determine anthropometric variables. The BMI, defined as the weight (kg) divided by the patient's height squared (m2), will be calculated. The height will be determined in centimeters using a measuring tape with the individual barefoot. Individuals with BMI <25 kg/m² will be classified as normal, overweight as a BMI between 25 and 30 kg/m², and obese as a BMI ≥30 kg/m². The waist circumference will be measured using a measuring tape at half the distance between the iliac crest and the lower costal margin. Patients will undergo the following tests before and after the end of the four-week study period: 24-hour ambulatory blood pressure monitoring (ABPM), 24-hour dynamic electrocardiography, continuous measurement of beat-to-beat BP, endothelial function measurement and radial artery applanation tonometry (AT).
Biochemical tests will be performed at two time points, before and after the four-week study period and include blood sugar, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), creatinine, potassium, uric acid, and plasma insulin levels. Blood sugar, TC, HDL-C and TG levels will be determined by colorimetry after fasting for 12 hours using a dimension device with the Dade Behring reagent. Diagnosis of diabetes mellitus (DM) will be established by patient history, the use of hypoglycemic drugs and measurement of the serum glucose. The LDL-C fraction will be calculated using the formula LDL-C = TC - HDL-C - TG / 5 (for TG <400 mg/dL). Additionally, the electrochemiluminescence method will be used to measure plasma insulin (immunoassay for the in vitro quantitative determination of human insulin in serum and plasma using the Elecsys 1010/2010 immunoassay and E170 modular analytics analyzers by Roche). The homeostasis model assessment of insulin resistance (HOMA-IR) index will be applied after obtaining blood sugar and insulin levels in order to determine insulin resistance and the functional capability of the pancreatic beta cells. Insulin resistance will be characterized when this ratio exceeds 2.71. The HOMA-IR index is calculated using the following formula:
HOMA-IR: Fasting insulin (McU/mL) x fasting glucose (mmol/L*) 22.5
In order to convert the glucose concentration to mmol/L it is necessary to multiply the value in mg/dL by 0.0555. Measurement of serum creatinine will be performed by a standardized enzyme-kinetic biochemical test and will be considered high when serum creatinine >1.4 mg/dL. Urinary sodium and potassium levels (mEq/L) will be evaluated by flame photometry. Urinary sodium excretion will be calculated by multiplying the urinary sodium and potassium concentrations in mEq/L by the 24-hour urine volume. The 24-hour urine volume and urinary creatinine concentrations will be assessed to calculate creatinine clearance adjusted for body surface.
Specific biochemical tests will be considered: serum aldosterone (AS), plasma renin activity (PRA), high-sensitivity C-reactive protein (hsCRP), metalloproteinase 9 (MMP-9), tissue inhibitor of metalloproteinases (TIMP-1 and TIMP-2), nitrites and nitrates, interleukin-1, 6, 8, 10 and 18 (IL-1, IL-6, IL-8, IL-10 and IL-18), tumor necrosis factor (TNF-α), thromboxane B2 (TXB2), fibrinogen, intercellular adhesion molecule (ICAM-1), plasminogen activator inhibitor (PAI-1), angiotensin converting enzyme (ACE) and angiotensin II (Ang II).
- Being tested
- Transcutaneous Electrical Stimulation, No Transcutaneous Electrical Stimulation
- Keywords
- arterial stiffness, resistant hypertension, sympathetic system, blood pressure, transcutaneous electrical nerve stimulation
- Medical subject headings
- Hypertension, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical StimulationDevice
TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 minutes three times weekly for a total of four weeks. The intensity in milliamps will be adjusted depending on the sensitivity of each individual patient.
No Transcutaneous Electrical StimulationDevice
The sham group will be submitted to the procedure to fit the stimulation equipment. without be submitted to stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Stimulation | Active comparator | TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 minutes three times weekly for a total of four weeks. The intensity in milliamps (mA) will be adjusted depending on the sensitivity of each individual patient. The arrangement thereof will be parallel on each side of the C7 (channel 1) and T4 (channel 2) vertebral spinous processes. Receives: Device: Transcutaneous Electrical Stimulation |
| No Transcutaneous Electrical Stimulation | Sham comparator | The sham group will be submitted to the procedure to fit the stimulation equipment without be submitted to stimulation. Receives: Device: No Transcutaneous Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in peripheral blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
Measured: 30 days
Secondary outcomes (1)
Change from baseline in central blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start1 Jun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE FERNANDO VILELA-MARTIN, Hospital de Base
- Investigators
- José F Vilela-Martin, MD PhD, Principal investigator, Fundação Faculdade Regional de Medicina de São José do Rio Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365974
- Sponsor's protocol ID
- RH-07606212500005415
- Acronym
- TENS
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2015
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Silva ML, Chiappa GR, da Silva VM, Neves LM, de Lima AC, Tomasi FP, Junior LT, Vilela-Martin JF, Bottaro M, Junior GC. Effect of transcutaneous electrical nerve stimulation on peripheral to central blood pressure ratio in healthy subjects. Clin Physiol Funct Imaging. 2016 Jul;36(4):293-7. doi: 10.1111/cpf.12227. Epub 2015 Jan 30.
PubMed 25640037Cipriano G Jr, Neder JA, Umpierre D, Arena R, Vieira PJ, Chiappa AM, Ribeiro JP, Chiappa GR. Sympathetic ganglion transcutaneous electrical nerve stimulation after coronary artery bypass graft surgery improves femoral blood flow and exercise tolerance. J Appl Physiol (1985). 2014 Sep 15;117(6):633-8. doi: 10.1152/japplphysiol.00993.2013. Epub 2014 Aug 7.
PubMed 25103974Vilela-Martin JF, Giollo-Junior LT, Chiappa GR, Cipriano-Junior G, Vieira PJ, dos Santos Ricardi F, Paz-Landim MI, de Andrade DO, Cestario Edo E, Cosenso-Martin LN, Yugar-Toledo JC, Cipullo JP. Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial. Trials. 2016 Mar 29;17:168. doi: 10.1186/s13063-016-1302-8.
PubMed 27026087
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure in Resistant Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT02365974
- Acronym / sponsor ID
- TENS / RH-07606212500005415
- Keywords
- arterial stiffness, resistant hypertension, sympathetic system, blood pressure, transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- 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.
Uncontrolled blood pressure represents the main factor in the development of target organ lesions and, consequently, cardiovascular events, which are the leading cause of morbidity and mortality worldwide. In most cases resistant hypertension is preceded by target organ lesions, and is strongly influenced by risk factors or associated diseases. To control this disease requires an adequate and intense therapeutic approach that includes lifestyle changes and the use of several antihypertensive drugs. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of resistant hypertension (RH), two, sympathetic overstimulation and therapies that block the sympathetic system, have been widely studied. But, these approaches are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a non-invasive method that modulates activity by inhibiting primary afferent pathways using low-frequency transcutaneous electrical stimulation. Some studies have shown that TENS reduces blood pressure in patients with hypertension. The current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low cost and readily available therapy to treat this group of hypertensive individuals.
Detailed description
Patients will be divided into two groups: treatment and control (sham group). The sham group will be submitted to the procedure to fit the stimulation equipment. However, these patients will not be submitted to stimulation. Both groups will undergo a physical examination at the start and end of the study period to determine anthropometric variables. The BMI, defined as the weight (kg) divided by the patient's height squared (m2), will be calculated. The height will be determined in centimeters using a measuring tape with the individual barefoot. Individuals with BMI <25 kg/m² will be classified as normal, overweight as a BMI between 25 and 30 kg/m², and obese as a BMI ≥30 kg/m². The waist circumference will be measured using a measuring tape at half the distance between the iliac crest and the lower costal margin. Patients will undergo the following tests before and after the end of the four-week study period: 24-hour ambulatory blood pressure monitoring (ABPM), 24-hour dynamic electrocardiography, continuous measurement of beat-to-beat BP, endothelial function measurement and radial artery applanation tonometry (AT).
Biochemical tests will be performed at two time points, before and after the four-week study period and include blood sugar, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), creatinine, potassium, uric acid, and plasma insulin levels. Blood sugar, TC, HDL-C and TG levels will be determined by colorimetry after fasting for 12 hours using a dimension device with the Dade Behring reagent. Diagnosis of diabetes mellitus (DM) will be established by patient history, the use of hypoglycemic drugs and measurement of the serum glucose. The LDL-C fraction will be calculated using the formula LDL-C = TC - HDL-C - TG / 5 (for TG <400 mg/dL). Additionally, the electrochemiluminescence method will be used to measure plasma insulin (immunoassay for the in vitro quantitative determination of human insulin in serum and plasma using the Elecsys 1010/2010 immunoassay and E170 modular analytics analyzers by Roche). The homeostasis model assessment of insulin resistance (HOMA-IR) index will be applied after obtaining blood sugar and insulin levels in order to determine insulin resistance and the functional capability of the pancreatic beta cells. Insulin resistance will be characterized when this ratio exceeds 2.71. The HOMA-IR index is calculated using the following formula:
HOMA-IR: Fasting insulin (McU/mL) x fasting glucose (mmol/L*) 22.5
In order to convert the glucose concentration to mmol/L it is necessary to multiply the value in mg/dL by 0.0555. Measurement of serum creatinine will be performed by a standardized enzyme-kinetic biochemical test and will be considered high when serum creatinine >1.4 mg/dL. Urinary sodium and potassium levels (mEq/L) will be evaluated by flame photometry. Urinary sodium excretion will be calculated by multiplying the urinary sodium and potassium concentrations in mEq/L by the 24-hour urine volume. The 24-hour urine volume and urinary creatinine concentrations will be assessed to calculate creatinine clearance adjusted for body surface.
Specific biochemical tests will be considered: serum aldosterone (AS), plasma renin activity (PRA), high-sensitivity C-reactive protein (hsCRP), metalloproteinase 9 (MMP-9), tissue inhibitor of metalloproteinases (TIMP-1 and TIMP-2), nitrites and nitrates, interleukin-1, 6, 8, 10 and 18 (IL-1, IL-6, IL-8, IL-10 and IL-18), tumor necrosis factor (TNF-α), thromboxane B2 (TXB2), fibrinogen, intercellular adhesion molecule (ICAM-1), plasminogen activator inhibitor (PAI-1), angiotensin converting enzyme (ACE) and angiotensin II (Ang II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Stimulation | Active comparator | Device: Transcutaneous Electrical StimulationTENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 minutes three times weekly for a total of four weeks. The intensity in milliamps (mA) will be adjusted depending on the sensitivity of each individual patient. The arrangement thereof will be parallel on each side of the C7 (channel 1) and T4 (channel 2) vertebral spinous processes. |
| No Transcutaneous Electrical Stimulation | Sham comparator | Device: No Transcutaneous Electrical StimulationThe sham group will be submitted to the procedure to fit the stimulation equipment without be submitted to stimulation. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RH patients taking at least three antihypertensive drugs at full doses, one of which is preferably a thiazide diuretic; Age between 40 and 70 years.
Key exclusion criteria (8 listed)
- Use of a cardiac pacemaker
- Cardiac electrical conduction abnormalities evidenced by ECG or stress test (ergometry)
- Dermatological abnormalities at the site of the application of TENS
- Uncontrolled diabetes patients using oral hypoglycemic agents or insulin with glycated Hb ≥ 7.5%
- Secondary Hypertension
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 Electrical StimulationTENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 minutes three times weekly for a total of four weeks. The intensity in milliamps will be adjusted depending on the sensitivity of each individual patient. | Device | Transcutaneous Electrical Stimulation |
| No Transcutaneous Electrical StimulationThe sham group will be submitted to the procedure to fit the stimulation equipment. without be submitted to stimulation. | Device | No Transcutaneous Electrical Stimulation |
Primary outcome
Change from baseline in peripheral blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
Time frame: 30 days
1 secondary outcome
Change from baseline in central blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 25640037da Silva ML, Chiappa GR, da Silva VM, Neves LM, de Lima AC, Tomasi FP, Junior LT, Vilela-Martin JF, Bottaro M, Junior GC. Effect of transcutaneous electrical nerve stimulation on peripheral to central blood pressure ratio in healthy subjects. Clin Physiol Funct Imaging. 2016 Jul;36(4):293-7. doi: 10.1111/cpf.12227. Epub 2015 Jan 30.
- Background: PubMed 25103974Cipriano G Jr, Neder JA, Umpierre D, Arena R, Vieira PJ, Chiappa AM, Ribeiro JP, Chiappa GR. Sympathetic ganglion transcutaneous electrical nerve stimulation after coronary artery bypass graft surgery improves femoral blood flow and exercise tolerance. J Appl Physiol (1985). 2014 Sep 15;117(6):633-8. doi: 10.1152/japplphysiol.00993.2013. Epub 2014 Aug 7.
- Derived from this study: PubMed 27026087Vilela-Martin JF, Giollo-Junior LT, Chiappa GR, Cipriano-Junior G, Vieira PJ, dos Santos Ricardi F, Paz-Landim MI, de Andrade DO, Cestario Edo E, Cosenso-Martin LN, Yugar-Toledo JC, Cipullo JP. Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial. Trials. 2016 Mar 29;17:168. doi: 10.1186/s13063-016-1302-8.
- Individual participant dataSharing planned: No
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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.
José F Vilela-Martin, MD PhD principal investigator
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Stimulation and No Transcutaneous Electrical Stimulation in people with Hypertension and Vascular Stiffness, run by Hospital de Base.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José F Vilela-Martin, MD PhD (551732015727 ext. 17, vilelamartin@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in peripheral blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation. (time frame: 30 days). 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 NCT02365974, which also lists 3 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 10 Feb 2021.