Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

Sponsor

Federal University of Health Science of Porto Alegre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06025643

Collaborator

Irmandade Santa Casa de Misericórdia de Porto Alegre (Other), Leonhardt Ventures LLC (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Hypertension Hypertension,Essential	Other: TENS - Cervical stimulation group Other: TENS - Plus cervical stimulation group Other: TENS - Renal stimulation group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 4, 2023

Anticipated Primary Completion Date :

Dec 4, 2023

Anticipated Study Completion Date :

Feb 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cervical stimulation group 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 TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.
Experimental: Plus cervical stimulation group 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 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.
Experimental: Renal stimulation group 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 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.
No Intervention: Control group This group will not receive any treatment with electrical stimulation.

Outcome Measures

Primary Outcome Measures

Systolic blood pressure [Baseline and after 4 weeks]
Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)
Diastolic blood pressure [Baseline and after 4 weeks]
Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)

Secondary Outcome Measures

Autonomic control [Baseline and after 4 weeks]
Autonomic control assessed by analysis of heart rate variability by frequency meter

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Leonhardt Ventures LLC

Investigators

Principal Investigator: Rodrigo DM Plentz, PhD, Federal University of Health Sciences of Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jociane Schardong, Principal Investigator, Federal University of Health Science of Porto Alegre

ClinicalTrials.gov Identifier:

NCT06025643

Other Study ID Numbers:

PressureStim

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Study Results

No Results Posted as of Sep 13, 2023