Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

Study Overview
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Brief Summary
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Systemic arterial hypertension is a disease characterized by high blood pressure levels. It has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS) is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been proposed as a non-pharmacological strategy for blood pressure control. The aim of this study is to verify the effect of low-frequency TENS when applied in different anatomical sites on blood pressure, autonomic control and endothelial function in hypertensive patients.

Detailed Description
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Systemic arterial hypertension is a disease characterized by high blood pressure levels. It has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS) is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been proposed as a non-pharmacological strategy for blood pressure control. The aim of this study is to verify the effect of low-frequency TENS when applied in different anatomical sites on blood pressure, autonomic control and endothelial function in hypertensive patients. For this, patients will be randomized into 4 groups: group 1 (cervical stimulation), group 2 (plus cervical stimulation ), group 3 (renal stimulation), group 4 (control). Group 1 will receive TENS in the cervical paravertebral region; group 2 will receive stimulation in the cervical paravertebral region, ear lobe, wrist and ankle. Group 3 will have the anatomical region of the kidneys stimulated. Group 4 will not receive any intervention. All the treated patients will receive 30 minutes of stimulation per session, regardless of group allocation. Ten applications will be carried out over the course of a month.

Official Title
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Effects of Electrical Nervous Stimulation Transcutaneous Analysis on Blood Pressure of Patients Hypertensive: Randomized Clinical Trial

Conditions
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Hypertension, Hypertension,Essential

Intervention / Treatment
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* Other: TENS - Cervical stimulation group
* Other: TENS - Plus cervical stimulation group
* Other: TENS - Renal stimulation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosis of systemic arterial hypertension: systolic blood pressure (SBP) ≥ 130 mmHg and diastolic blood pressure (DBP) ≥ 80 mmHg diagnosed by ambulatory blood pressure monitoring (ABPM). Exclusion Criteria: Congestive heart failure Patients with a cardiac pacemaker Previous heart surgery Patients with serum creatinine >2.5 mg/dL Change in drug therapy in the two months prior to starting the study Active smoking

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical stimulation group<br>TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks. | Other: TENS - Cervical stimulation group<br>* TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.<br>|
| Experimental: Plus cervical stimulation group<br>TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks. | Other: TENS - Plus cervical stimulation group<br>* TENS will be applied bilaterally in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes, on the earlobe, on the wrists and ankles simultaneously.<br>|
| Experimental: Renal stimulation group<br>TENS will be applied for 30 minutes with a frequency of 5 Hz, pulse width of 200 µs and sufficient intensity to reach the sensory threshold. Ten sessions will be performed over four weeks. | Other: TENS - Renal stimulation group<br>* TENS will be applied through self-adhesive electrodes in the abdomen (anatomical region corresponding to the kidneys) and dorsal region at the level of the 10th thoracic vertebra.<br>|
| No Intervention: Control group<br>This group will not receive any treatment with electrical stimulation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM) | Baseline and after 4 weeks | 
| Diastolic blood pressure | Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM) | Baseline and after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic control | Autonomic control assessed by analysis of heart rate variability by frequency meter | Baseline and after 4 weeks |