NCT06025643

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 29, 2023

Last Update Submit

November 29, 2023

Conditions

HypertensionHypertension,Essential

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Autonomic control

    Baseline and after 4 weeks

Study Arms (4)

Cervical stimulation group

EXPERIMENTAL

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

Plus cervical stimulation group

EXPERIMENTAL

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

Renal stimulation group

EXPERIMENTAL

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

Control group

NO INTERVENTION

This group will not receive any treatment with electrical stimulation.

Interventions

TENS - Cervical stimulation groupOTHER

TENS will be applied bilaterally through self-adhesive electrodes in the cervicothoracic ganglionic region, located between the C7 and T4 vertebral processes.

Cervical stimulation group
TENS - Plus cervical stimulation groupOTHER

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.

Plus cervical stimulation group
TENS - Renal stimulation groupOTHER

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.

Renal stimulation group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Rodrigo DM Plentz, PhD

    Federal University of Health Sciences of Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jociane Schardong, PhD

CONTACT

55981348114joci_fisioufsm@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

December 10, 2023

Primary Completion

February 10, 2024

Study Completion

April 10, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share