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Completed

NCT Number: NCT01390701

Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical nerve stimulation

Device

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

Other names: 2 Hz Primo Pro stimulators (CefarCompex, Sweden).

felodipin

Drug

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

Primary outcomes

  1. Blood pressure reduction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: HyperTENSion

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 11, 2011
Registry last updated
Jul 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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