Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure
TENS
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure in Resistant Hypertensive Individuals
1 other identifier
interventional
64
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Jun 2021
Shorter than P25 for not_applicable hypertension
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
February 8, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFebruary 10, 2021
February 1, 2021
6 months
February 8, 2015
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in peripheral blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
30 days
Secondary Outcomes (1)
Change from baseline in central blood pressure of individuals with resistant hypertension after transcutaneous electrical nervous stimulation.
30 days
Study Arms (2)
Transcutaneous Electrical Stimulation
ACTIVE COMPARATORTENS 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 (mA) will be adjusted depending on the sensitivity of each individual patient. The arrangement thereof will be parallel on each side of the C7 (channel 1) and T4 (channel 2) vertebral spinous processes.
No Transcutaneous Electrical Stimulation
SHAM COMPARATORThe sham group will be submitted to the procedure to fit the stimulation equipment without be submitted to stimulation.
Interventions
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.
The sham group will be submitted to the procedure to fit the stimulation equipment. without be submitted to stimulation.
Eligibility Criteria
You may qualify if:
- RH patients taking at least three antihypertensive drugs at full doses, one of which is preferably a thiazide diuretic; Age between 40 and 70 years.
You may not qualify if:
- Use of a cardiac pacemaker
- Cardiac electrical conduction abnormalities evidenced by ECG or stress test (ergometry)
- Dermatological abnormalities at the site of the application of TENS
- Uncontrolled diabetes patients using oral hypoglycemic agents or insulin with glycated Hb ≥ 7.5%
- Secondary Hypertension
- Patients who do not adhere to the lifestyle changes recommended by their physician such as low-sodium diet and weight loss
- Moderate to severe cervical-thoracic scoliosis
- Obesity with body mass index (BMI) ≥35 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Baselead
Related Publications (3)
da Silva ML, Chiappa GR, da Silva VM, Neves LM, de Lima AC, Tomasi FP, Junior LT, Vilela-Martin JF, Bottaro M, Junior GC. Effect of transcutaneous electrical nerve stimulation on peripheral to central blood pressure ratio in healthy subjects. Clin Physiol Funct Imaging. 2016 Jul;36(4):293-7. doi: 10.1111/cpf.12227. Epub 2015 Jan 30.
PMID: 25640037BACKGROUNDCipriano G Jr, Neder JA, Umpierre D, Arena R, Vieira PJ, Chiappa AM, Ribeiro JP, Chiappa GR. Sympathetic ganglion transcutaneous electrical nerve stimulation after coronary artery bypass graft surgery improves femoral blood flow and exercise tolerance. J Appl Physiol (1985). 2014 Sep 15;117(6):633-8. doi: 10.1152/japplphysiol.00993.2013. Epub 2014 Aug 7.
PMID: 25103974BACKGROUNDVilela-Martin JF, Giollo-Junior LT, Chiappa GR, Cipriano-Junior G, Vieira PJ, dos Santos Ricardi F, Paz-Landim MI, de Andrade DO, Cestario Edo E, Cosenso-Martin LN, Yugar-Toledo JC, Cipullo JP. Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial. Trials. 2016 Mar 29;17:168. doi: 10.1186/s13063-016-1302-8.
PMID: 27026087DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José F Vilela-Martin, MD PhD
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinator of Hypertension Clinic
Study Record Dates
First Submitted
February 8, 2015
First Posted
February 19, 2015
Study Start
June 1, 2021
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share