Trial record 3 of 5841 for:    hypertension

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

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01390701
First received: July 7, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Blood pressure reduction [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390701

Locations
Sweden
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
  More Information

No publications provided

Responsible Party: Jonas Silverdal MD, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT01390701     History of Changes
Other Study ID Numbers: HyperTENSion
Study First Received: July 7, 2011
Last Updated: July 7, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
randomized
cross-over
transcutaneous electrical nerve stimulation
felodipin
hypertension
blood pressure
treatment

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014