Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

Hypertension Clinical Trial

— HyperTENSion  

Official title:

Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390701
• Other study ID #: HyperTENSion
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: July 7, 2011
• Start date: January 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure reduction	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	four weeks	No