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HyperTENSion: Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Completed
CT.gov ID
NCT01390701
Collaborator
(none)
41
Enrollment
1
Location
2
Arms
20
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
N/A

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 Design

Study Type:
Interventional
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 :
Jan 1, 2008
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

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 Names:
  • 2 Hz Primo Pro stimulators (CefarCompex, Sweden).

    		•
    Active Comparator: felodipin

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

    Outcome Measures

    Primary Outcome Measures

    1. Blood pressure reduction [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra Göteborg Sweden

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden

    Investigators

    • Principal Investigator: Jonas Silverdal, MD, Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
    • Principal Investigator: Karin Manhem, ass.prof., 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, ass.prof., Institute of Neuroscience and Physiology, Department of Physiology, University of Gothenburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01390701
    Other Study ID Numbers:
    • HyperTENSion
    First Posted:
    Jul 11, 2011
    Last Update Posted:
    Jul 11, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    randomized
    cross-over
    transcutaneous electrical nerve stimulation
    felodipin
    hypertension
    blood pressure
    treatment
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Jul 11, 2011