Original Query: hypertension
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Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation (HyperTENSion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01390701
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
Information provided by:
Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment
Hypertension Device: transcutaneous electrical nerve stimulation 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin
Study Start Date : January 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: transcutaneous electr. nerve stimulation Device: transcutaneous electrical nerve stimulation
30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.
Other Name: 2 Hz Primo Pro stimulators (CefarCompex, Sweden).
Active Comparator: felodipin Drug: felodipin
2,5mg of felodipin once daily. Duration: 28+-4 days.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01390701

Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
Göteborg, Sweden
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Principal Investigator: Jonas Silverdal, MD Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
Principal Investigator: Karin Manhem, Institute of Medicine, Department of Emergency and Cardiovascular Medicine, Sahlgrenska University Hospital/Sahlgrenska
Principal Investigator: Clas Mannheimer, professor Multidisciplinary Pain Center, Sahlgrenska University Hospital/Östra
Principal Investigator: Georgios Mourtzinis, MD Department of Medicine, Sahlgrenska University Hospital/Mölndal
Principal Investigator: Elisabet Stener-Victorin, Institute of Neuroscience and Physiology, Department of Physiology, University of Gothenburg

Responsible Party: Jonas Silverdal MD, Sahlgrenska University Hospital Identifier: NCT01390701     History of Changes
Other Study ID Numbers: HyperTENSion
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: June 2011

Keywords provided by Sahlgrenska University Hospital, Sweden:
transcutaneous electrical nerve stimulation
blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases