HypertensionHyperTENSionNCT01390701
Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation
A study testing transcutaneous electrical nerve stimulation and felodipin in people with Hypertension, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- transcutaneous electrical nerve stimulation and felodipin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (BP) lowering agent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
Gothenburg
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- transcutaneous electrical nerve stimulation, felodipin
- Keywords
- randomized, cross-over, transcutaneous electrical nerve stimulation, felodipin, hypertension, blood pressure, treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulationDevice
Also called 2 Hz Primo Pro stimulators (CefarCompex, Sweden).
30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.
felodipinDrug
2,5mg of felodipin once daily. Duration: 28+-4 days.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electr. nerve stimulation | Experimental | Not described Receives: Device: transcutaneous electrical nerve stimulation |
| felodipin | Active comparator | Not described Receives: Drug: felodipin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jonas Silverdal, MD, Principal investigator, Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/ÖstraKarin Manhem, ass.prof., Principal investigator, Institute of Medicine, Department of Emergency and Cardiovascular Medicine, Sahlgrenska University Hospital/SahlgrenskaClas Mannheimer, professor, Principal investigator, Multidisciplinary Pain Center, Sahlgrenska University Hospital/ÖstraGeorgios Mourtzinis, MD, Principal investigator, Department of Medicine, Sahlgrenska University Hospital/MölndalElisabet Stener-Victorin, ass.prof., Principal investigator, Institute of Neuroscience and Physiology, Department of Physiology, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390701
- Sponsor's protocol ID
- HyperTENSion
- Acronym
- HyperTENSion
- Status last verified
- Jun 2011
- First submitted
- 7 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin
- ClinicalTrials.gov ID
- NCT01390701
- Acronym / sponsor ID
- HyperTENSion / HyperTENSion
- Conditions
- Hypertension
- Keywords
- randomized, cross-over, transcutaneous electrical nerve stimulation, felodipin, hypertension, blood pressure, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electr. nerve stimulation | Experimental | Device: transcutaneous electrical nerve stimulation |
| felodipin | Active comparator | Drug: felodipin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (BP) lowering agent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical nerve stimulationAlso: 2 Hz Primo Pro stimulators (CefarCompex, Sweden).30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days. | Device | transcutaneous electr. nerve stimulation |
| felodipin2,5mg of felodipin once daily. Duration: 28+-4 days. | Drug | felodipin |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Silverdal, MD principal investigator
Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
Karin Manhem, ass.prof. 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation and felodipin in people with Hypertension, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure reduction (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.