Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Hypertension,Essential
• Interventions: Other: TENS - Plus cervical stimulation group; Other: TENS - Renal stimulation group; Other: TENS - Cervical stimulation group

• Registration Number: NCT06025643
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief 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.

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 Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Study Start: 2023-12-10
• Primary Completion: 2024-02-10
• Study Completion: 2024-04-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plus cervical stimulation group	TENS - 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.
Renal stimulation group	TENS - 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.
Cervical stimulation group	TENS - 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Autonomic control	Baseline and after 4 weeks	Autonomic control assessed by analysis of heart rate variability by frequency meter