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Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure

NCT02365974 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-02-10

No results posted yet for this study

Summary

Uncontrolled blood pressure represents the main factor in the development of target organ lesions and, consequently, cardiovascular events, which are the leading cause of morbidity and mortality worldwide. In most cases resistant hypertension is preceded by target organ lesions, and is strongly influenced by risk factors or associated diseases. To control this disease requires an adequate and intense therapeutic approach that includes lifestyle changes and the use of several antihypertensive drugs. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of resistant hypertension (RH), two, sympathetic overstimulation and therapies that block the sympathetic system, have been widely studied. But, these approaches are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a non-invasive method that modulates activity by inhibiting primary afferent pathways using low-frequency transcutaneous electrical stimulation. Some studies have shown that TENS reduces blood pressure in patients with hypertension. The current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low cost and readily available therapy to treat this group of hypertensive individuals.

Conditions

  • Hypertension
  • Vascular Stiffness
  • Autonomic Nervous System Diseases

Interventions

DEVICE

Transcutaneous Electrical Stimulation

TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 minutes three times weekly for a total of four weeks. The intensity in milliamps will be adjusted depending on the sensitivity of each individual patient.

DEVICE

No Transcutaneous Electrical Stimulation

The sham group will be submitted to the procedure to fit the stimulation equipment. without be submitted to stimulation.

Sponsors & Collaborators

  • Hospital de Base

    lead OTHER

Principal Investigators

  • José F Vilela-Martin, MD PhD · Fundação Faculdade Regional de Medicina de São José do Rio Preto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-12-31
Completion
2022-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365974 on ClinicalTrials.gov