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Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation (HyperTENSion)

This study has been completed.
Information provided by:
Sahlgrenska University Hospital, Sweden Identifier:
First received: July 7, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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 Intervention
Hypertension Device: transcutaneous electrical nerve stimulation Drug: felodipin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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

Enrollment: 41
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Jonas Silverdal MD, Sahlgrenska University Hospital Identifier: NCT01390701     History of Changes
Other Study ID Numbers: HyperTENSion
Study First Received: July 7, 2011
Last Updated: July 7, 2011

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on August 16, 2017