Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01390701

Acronym

HyperTENSion

Enrollment

Registered

2011-07-11

Start date

2008-01-31

Completion date

2009-09-30

Last updated

2011-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

randomized, cross-over, transcutaneous electrical nerve stimulation, felodipin, hypertension, blood pressure, treatment

Brief summary

The purpose of this study is to compare the blood pressure reducing property of transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.

Detailed description

Hypertension is a major risk factor for development of several vascular complications and is common world wide. Drug treatment is often necessary to achieve adequate blood pressure reduction but blood pressure control in studied countries is unsatisfactory low. Reasons for failure in treatment are several. Among others reasons intolerable side-effects may prevent successful treatment irrespective of the number of drugs. Transcutaneous electrical nerve stimulation (TENS) constitutes no risk of interaction with pharmacological agents and previous studies have reported blood pressure reduction.

Interventions

DEVICEtranscutaneous electrical nerve stimulation

30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.

DRUGfelodipin

2,5mg of felodipin once daily. Duration: 28+-4 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (BP) lowering agent

Exclusion criteria

* systolic blood pressure \>170 mmHg and/or diastolic blood pressure of \>105 mmHg * second- or third-degree atrioventricular block * current use of opiates or other intoxicants * neurological disorders (such as Parkinson's disease, multiple sclerosis or peripheral neuropathy) * need of treatment with TENS, regardless the reason

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure reduction	four weeks	Office blood pressure measurement and 24-h ambulatory blood pressure monitoring after four week periods of treatment in a cross-over design with intervening four week washout and subsequent four week follow-up

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026