Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

Brief Summary

Official Title: “Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2009

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Device: transcutaneous electrical nerve stimulation
    • 30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.
  • Drug: felodipin
    • 2,5mg of felodipin once daily. Duration: 28+-4 days.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: transcutaneous electr. nerve stimulation
  • Active Comparator: felodipin

Outcome Measures for this Clinical Trial

Primary Measures

  • Blood pressure reduction
    • Time Frame: four weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Sahlgrenska University Hospital, Sweden
  • Provider of Information About this Clinical Study
    • Jonas Silverdal MD, Sahlgrenska University Hospital
  • Overall Official(s)
    • Jonas Silverdal, MD, Principal Investigator, Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
    • Karin Manhem,, Principal Investigator, Institute of Medicine, Department of Emergency and Cardiovascular Medicine, Sahlgrenska University Hospital/Sahlgrenska
    • Clas Mannheimer, professor, Principal Investigator, Multidisciplinary Pain Center, Sahlgrenska University Hospital/Östra
    • Georgios Mourtzinis, MD, Principal Investigator, Department of Medicine, Sahlgrenska University Hospital/Mölndal
    • Elisabet Stener-Victorin,, Principal Investigator, Institute of Neuroscience and Physiology, Department of Physiology, University of Gothenburg


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