- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02365974
Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure (TENS)
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure in Resistant Hypertensive Individuals
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: José F Vilela-Martin, MD PhD
- Phone Number: 17 551732015727
- Email: vilelamartin@uol.com.br
Study Contact Backup
- Name: Luiz Tadeu Giollo Júnior, PT
- Phone Number: 5517981326219
- Email: ltgg@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transcutaneous Electrical Stimulation
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.
|
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.
|
Sham Comparator: No Transcutaneous Electrical Stimulation
The sham group will be submitted to the procedure to fit the stimulation equipment without be submitted to stimulation.
|
The sham group will be submitted to the procedure to fit the stimulation equipment.
without be submitted to stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in peripheral blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in central blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cipriano 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.
- 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.
- Vilela-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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RH-07606212500005415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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