Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06025643
• Other study ID #: PressureStim
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: November 2023
• Source: Federal University of Health Science of Porto Alegre
• Contact: Jociane Schardong, PhD
• Phone: 55981348114
• Email: joci_fisioufsm[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Other:
• TENS - Cervical stimulation group
TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.
• TENS - Plus cervical stimulation group
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.
• TENS - Renal stimulation group
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)	Baseline and after 4 weeks
Primary	Diastolic blood pressure	Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)	Baseline and after 4 weeks
Secondary	Autonomic control	Autonomic control assessed by analysis of heart rate variability by frequency meter	Baseline and after 4 weeks