Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

Study Overview
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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.

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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: transcutaneous electrical nerve stimulation
* Drug: felodipin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous electr. nerve stimulation<br> | Device: transcutaneous electrical nerve stimulation<br>* 30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.<br>* Other names: 2 Hz Primo Pro stimulators (CefarCompex, Sweden).;|
| Active Comparator: felodipin<br> | Drug: felodipin<br>* 2,5mg of felodipin once daily. Duration: 28+-4 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure reduction | 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 | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, cross-over, transcutaneous electrical nerve stimulation, felodipin, hypertension, blood pressure, treatment