Hypertension, Hypertension,Essential
Conditions
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.
Interventions
OTHERTENS - 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.
OTHERTENS - 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.
OTHERTENS - 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.
Sponsors
Irmandade Santa Casa de Misericórdia de Porto Alegre
Leonhardt Ventures LLC
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Autonomic control | Baseline and after 4 weeks | Autonomic control assessed by analysis of heart rate variability by frequency meter |
Contacts
Primary ContactJociane Schardong, PhD
Outcome results
None listed