Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation (HyperTENSion)
|ClinicalTrials.gov Identifier: NCT01390701|
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
|Condition or disease||Intervention/treatment|
|Hypertension||Device: transcutaneous electrical nerve stimulation Drug: felodipin|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin|
|Study Start Date :||January 2008|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
|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||
2,5mg of felodipin once daily. Duration: 28+-4 days.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390701
|Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra|
|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|