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Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

Primary Purpose

Hypertension, Hypertension,Essential

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS - Cervical stimulation group
TENS - Plus cervical stimulation group
TENS - Renal stimulation group
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Cervical stimulation group

    Plus cervical stimulation group

    Renal stimulation group

    Control group

    Arm Description

    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.

    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.

    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.

    This group will not receive any treatment with electrical stimulation.

    Outcomes

    Primary Outcome Measures

    Systolic blood pressure
    Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)
    Diastolic blood pressure
    Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)

    Secondary Outcome Measures

    Autonomic control
    Autonomic control assessed by analysis of heart rate variability by frequency meter

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    September 8, 2023
    Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06025643
    Brief Title
    Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients
    Official Title
    Effects of Electrical Nervous Stimulation Transcutaneous Analysis on Blood Pressure of Patients Hypertensive: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 4, 2023 (Anticipated)
    Primary Completion Date
    December 4, 2023 (Anticipated)
    Study Completion Date
    February 4, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Hypertension,Essential

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cervical stimulation group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Plus cervical stimulation group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Renal stimulation group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    This group will not receive any treatment with electrical stimulation.
    Intervention Type
    Other
    Intervention Name(s)
    TENS - Cervical stimulation group
    Intervention Description
    TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.
    Intervention Type
    Other
    Intervention Name(s)
    TENS - Plus cervical stimulation group
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    TENS - Renal stimulation group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)
    Time Frame
    Baseline and after 4 weeks
    Title
    Diastolic blood pressure
    Description
    Systolic blood pressure assessed by ambulatory blood pressure monitoring (ABPM)
    Time Frame
    Baseline and after 4 weeks
    Secondary Outcome Measure Information:
    Title
    Autonomic control
    Description
    Autonomic control assessed by analysis of heart rate variability by frequency meter
    Time Frame
    Baseline and after 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jociane Schardong, PhD
    Phone
    55981348114
    Email
    joci_fisioufsm@yahoo.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodrigo DM Plentz, PhD
    Organizational Affiliation
    Federal University of Health Sciences of Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

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