HypertensionNCT06401278
Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure In Primary Hypertension Patients
A study testing Transcutaneous electrical acupoint stimulation and Transcutaneous electrical nerve stimulation (group b): in people with Hypertension and Quality of Life, run by Tawfik Tawfik Mahmoud Emara at 1 site in Egypt.
Trial summary
To compare between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension BACKGROUND: The current American College of Cardiology and the American Heart Association (ACC/AHA) 2017 guidelines define hypertension as systolic BP… Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Hypertension, Quality of Life
- What is being tested?
- Transcutaneous electrical acupoint stimulation and Transcutaneous electrical nerve stimulation (group b):
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2024to 10 Aug 2024
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) Sixty patients from both sexes diagnosed with essential HT at least 6 months ago.
- 2) Their age will be ranged from 50 to 60 years old. 3) Their blood pressure will be ranged from (SBP is 140 -159 mmHg and/or DBP is 90-99 mmHg).
- 4) Their body mass index (BMI) ranged from will be ranged from 24.9 to 29.9 kg/m2.
- 5) All patients are medically stable and receive the same medical treatment 6) All patient nonsmoker or quitted smoking for at least 4-5 years 7) All patients will be similar in terms of status of functional activity, status of eating a salt-free diet and the presence of any chronic disease except HT
Who cannot join
- 1) Secondary hypertension 2) Patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery.
- 3) Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.
- 4) Use of a cardiac pacemaker 5) Any metal implants at site of application of TENS 6) Dermatological abnormalities at the site of the application of TENS 7) Obesity with body mass index (BMI) > 30 kg/m2 8) Smoker, diabetes. 9) Soft tissue, nerve, and vascular diseases of upper or lower extremities which hinder the application of TEAS.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy- Cairo Uni.
Giza, 12611
Hanan Mohamed, BSc, 01151312322 ext. 002, eth.com@pt.cu.edu.eg
About this study
Official title: Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure And Quality Of Life In Patients With Primary Hypertension
To compare between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
BACKGROUND:
Read more
The current American College of Cardiology and the American Heart Association (ACC/AHA) 2017 guidelines define hypertension as systolic BP (SBP) of ≥130 mmHg or diastolic BP (DBP) of ≥80 mmHg. In adults, an increase of 20 mmHg in SBP or 10 mmHg in DBP is associated with more than a two-fold increase in mortality owing to stroke and other cardiovascular diseases. Hypertension accounts for 13% of premature deaths worldwide and is the third leading cause of disability-adjusted life years (Shah et al., 2022).
Transcutaneous electrical nerve stimulation of the Neiguan (P6) point with acupressure is possibly affecting the blood pressure by protecting the myocardial tissues and influencing the nervous system through regulating the autonomic nervous system function and reduction in sympathetic activity. (Hassanein et al., 2021).
HYPOTHESES There will be no a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
RESEARCH QUESTION:
Is there a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension?
Evaluating equipment, pre-post intervension outcomes:
- BP by Digital Sphygmomanometer
- quality of life by The SF-12 health status questionnaire
- nitric oxide level in blood by nitric Oxide analysis.
- sleep quality. by Pittsburgh Sleep Quality Index (PSQI)
- exercise capacity and endurance by Thirty-Second Sit-To-Stand Test (30 STST)
- Conditions
- Hypertension, Quality of Life
- Being tested
- Transcutaneous electrical acupoint stimulation, Transcutaneous electrical nerve stimulation (group b):
- 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 acupoint stimulationDevice
It will be performed by using the TENS device on acupoint (TEAS) as the following:
The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6)
Transcutaneous electrical nerve stimulation (group b):Device
TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical acupoint stimulation (Group A): | Experimental | Transcutaneous electrical acupoint stimulation :It will be performed by using the TENS device on acupoint (TEAS) as the following:
The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6) Receives: Device: Transcutaneous electrical acupoint stimulation |
| Transcutaneous electrical nerve stimulation(Group b): | Experimental | TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks. Receives: Device: Transcutaneous electrical nerve stimulation (group b): |
| Control | No intervention | Routine medical treatment: (Group c): receive only routine medical treatment (antihypertensive medication, instructions and education to control blood pressure) * Nutrition Eat a diet that is high in fiber and potassium, and low in salt (sodium), added sugar, and fat. * Lifestyle Do not use any products that contain nicotine or tobacco, such as cigarettes, and chewing tobacco. * Identify your sources of stress and find ways to manage stress. This may include deep breathing or making time for fun activities. * Do not drink alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure by using a digital sphygmomanometer
Blood pressure was recorded by using a digital sphygmomanometer
Measured: six weeks
quality of life by Short Form twelve health status questionnaire
by Short Form twelve health status questionnaire Health-Related Quality of Life survey consisting of twelve questions that measure eight health domains to assess physical and mental health.The score ranges from 0 to 100, with a higher score indicating better physical and mental health functioning.
Measured: six weeks
Nitric oxide by nitric oxide sample analysis
by nitric oxide sample analysis
Measured: six weeks
Secondary outcomes (2)
exercise capacity and endurance measured by Thirty-Second Sit-To-Stand Test (30 STST)
measured by Thirty-Second Sit-To-Stand Test (30 STST)
Measured: six weeks
sleep quality
Measured by Pittsburgh Sleep Quality Index (PSQI) It assesses sleep quality through seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) which the participant is asked to recall over the past month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality than lowest component.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start5 May 2024
- Primary completion5 Aug 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tawfik Tawfik Mahmoud Emara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tawfik Tawfik Mahmoud Emara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401278
- Sponsor's protocol ID
- P.T.REC/012/004443
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure And Quality Of Life In Patients With Primary Hypertension
- ClinicalTrials.gov ID
- NCT06401278
- Acronym / sponsor ID
- P.T.REC/012/004443
- Conditions
- Hypertension, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tawfik Tawfik Mahmoud EmaraUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 5 Aug 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- 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.
To compare between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
BACKGROUND:
The current American College of Cardiology and the American Heart Association (ACC/AHA) 2017 guidelines define hypertension as systolic BP (SBP) of ≥130 mmHg or diastolic BP (DBP) of ≥80 mmHg. In adults, an increase of 20 mmHg in SBP or 10 mmHg in DBP is associated with more than a two-fold increase in mortality owing to stroke and other cardiovascular diseases. Hypertension accounts for 13% of premature deaths worldwide and is the third leading cause of disability-adjusted life years (Shah et al., 2022).
Transcutaneous electrical nerve stimulation of the Neiguan (P6) point with acupressure is possibly affecting the blood pressure by protecting the myocardial tissues and influencing the nervous system through regulating the autonomic nervous system function and reduction in sympathetic activity. (Hassanein et al., 2021).
HYPOTHESES There will be no a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
RESEARCH QUESTION:
Is there a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension?
Evaluating equipment, pre-post intervension outcomes:
- BP by Digital Sphygmomanometer
- quality of life by The SF-12 health status questionnaire
- nitric oxide level in blood by nitric Oxide analysis.
- sleep quality. by Pittsburgh Sleep Quality Index (PSQI)
- exercise capacity and endurance by Thirty-Second Sit-To-Stand Test (30 STST)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical acupoint stimulation (Group A): | Experimental | Device: Transcutaneous electrical acupoint stimulationTranscutaneous electrical acupoint stimulation :It will be performed by using the TENS device on acupoint (TEAS) as the following: The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6) |
| Transcutaneous electrical nerve stimulation(Group b): | Experimental | Device: Transcutaneous electrical nerve stimulation (group b):TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks. |
| Control | No intervention | –Routine medical treatment: (Group c): receive only routine medical treatment (antihypertensive medication, instructions and education to control blood pressure) * Nutrition Eat a diet that is high in fiber and potassium, and low in salt (sodium), added sugar, and fat. * Lifestyle Do not use any products that contain nicotine or tobacco, such as cigarettes, and chewing tobacco. * Identify your sources of stress and find ways to manage stress. This may include deep breathing or making time for fun activities. * Do not drink alcohol |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1) Sixty patients from both sexes diagnosed with essential HT at least 6 months ago.
- 2) Their age will be ranged from 50 to 60 years old. 3) Their blood pressure will be ranged from (SBP is 140 -159 mmHg and/or DBP is 90-99 mmHg).
- 4) Their body mass index (BMI) ranged from will be ranged from 24.9 to 29.9 kg/m2.
- 5) All patients are medically stable and receive the same medical treatment 6) All patient nonsmoker or quitted smoking for at least 4-5 years 7) All patients will be similar in terms of status of functional activity, status of eating a salt-free diet and the presence of any chronic disease except HT
Key exclusion criteria (3 listed)
- 1) Secondary hypertension 2) Patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery.
- 3) Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.
- 4) Use of a cardiac pacemaker 5) Any metal implants at site of application of TENS 6) Dermatological abnormalities at the site of the application of TENS 7) Obesity with body mass index (BMI) > 30 kg/m2 8) Smoker, diabetes. 9) Soft tissue, nerve, and vascular diseases of upper or lower extremities which hinder the application of TEAS.
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 acupoint stimulationIt will be performed by using the TENS device on acupoint (TEAS) as the following: The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6) | Device | Transcutaneous electrical acupoint stimulation (Group A): |
| Transcutaneous electrical nerve stimulation (group b):TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks. | Device | Transcutaneous electrical nerve stimulation(Group b): |
Primary outcome
Blood Pressure by using a digital sphygmomanometer
Time frame: six weeks
Blood pressure was recorded by using a digital sphygmomanometer
quality of life by Short Form twelve health status questionnaire
Time frame: six weeks
by Short Form twelve health status questionnaire Health-Related Quality of Life survey consisting of twelve questions that measure eight health domains to assess physical and mental health.The score ranges from 0 to 100, with a higher score indicating better physical and mental health functioning.
Nitric oxide by nitric oxide sample analysis
Time frame: six weeks
by nitric oxide sample analysis
2 secondary outcomes
exercise capacity and endurance measured by Thirty-Second Sit-To-Stand Test (30 STST)
Time frame: six weeks
sleep quality
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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.
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 acupoint stimulation and Transcutaneous electrical nerve stimulation (group b): in people with Hypertension and Quality of Life, run by Tawfik Tawfik Mahmoud Emara at 1 site in Egypt.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure by using a digital sphygmomanometer (time frame: six weeks). The study lists 3 primary outcomes in all. 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 7 May 2024.