Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transcutaneous electr. nerve stimulation

Group Type EXPERIMENTAL

transcutaneous electrical nerve stimulation

Intervention Type DEVICE

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

felodipin

Group Type ACTIVE_COMPARATOR

felodipin

Intervention Type DRUG

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

Interventions

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transcutaneous electrical nerve stimulation

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

Intervention Type DEVICE

felodipin

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

Intervention Type DRUG

Other Intervention Names

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2 Hz Primo Pro stimulators (CefarCompex, Sweden).

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No