Comparing the effect of electro acupuncture and laser acupuncture in the treatment of patients with mild high blood pressure
Design
The clinical trial has a control group, a blind strain, randomized on 30 patients, and the rand function of Excel software is used for randomization
Settings and conduct
The place of study is in the research center clinic of Semnan University of Medical Sciences. The method of doing the work is that the patients are divided into 3 groups, in which 1 intervention group electro acupuncture on 10 specified points and in the other group laser acupuncture on 10 specified points like The previous group is applied and no intervention is received in the control group. Blood pressure is evaluated by a Holter device before and after the intervention and by a digital Barometer before and after the first session and a general question about the patient's blood pressure status is performed in the 1 month follow-up and the results are analyzed. The study is a blinded strain.
Participants/Inclusion and exclusion criteria
Patients with mild hypertension (stage 1), i.e., systolic blood pressure between 140 and 159 mm Hg and diastolic blood pressure between 90 and 99 mm Hg, who have been receiving medical treatment for high blood pressure for more than one year.
Patients should not take more than one type of blood pressure medication per day, and also patients should not have high blood pressure secondary to other diseases.
Intervention groups
The intervention of electro acupuncture and laser acupuncture is applied in 2 treatment groups, and in the control group, the patients do not receive any intervention and only take their medicine.
in both intervention groups, patients continue to take their medicine.
Main outcome variables
Examination of systolic and diastolic blood pressure and heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029264N16
Registration date:2023-04-12, 1402/01/23
Registration timing:prospective
Last update:2023-04-12, 1402/01/23
Update count:0
Registration date
2023-04-12, 1402/01/23
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Electro Acupuncture and Laser Acupuncture in the treatment of patients with mild high blood pressure
Public title
Comparison of the effect of Electro Acupuncture and Laser Acupuncture in the treatment of patients with mild high blood pressure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild hypertension (stage 1) , i.e., systolic blood pressure between 140 and 159 mmHg and diastolic blood pressure between 90 and 99 mmHg
have been receiving medical treatment for hypertension for more than one year
Exclusion criteria:
Patients with a habit of physical activity or special diet such as yoga, meditation, auriculotherapy, acupuncture, etc.
Taking more than one type of blood pressure medicine per day
patients with high blood pressure secondary to other diseases
receiving acupuncture treatment in the last month
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method: sealed envelopes and numbers 1 to 30 are written on each paper, and then each envelope is assigned to one person by lottery and numbers 1, 4, 7 and ... so on. belong to the first group and the numbers 2 5 8 and... to the second group and the numbers 3 6 9 and ... They belong to the third group
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the person responsible for blood pressure measurement is unaware of the grouping of people
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Pasteur Square, Western Pastor St., Ajideh St., Gudarzi Alley, Kambiz Dead End, No. 2, Unit 2
City
Tehran
Province
Tehran
Postal code
1318845581
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SEMUMS.REC.1402.002
Health conditions studied
1
Description of health condition studied
high blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
Before the intervention - before the first session - after the first session - at the end of 8 sessions - one month follow-up
Intervention group: Applying electroacupuncture in the form of 2 sessions a week for 4 weeks, each session will last 30 minutes, and during this period, 10 needles will be inserted in points LR3, ST36, PC6, PC5, and LI11, and electric current with a frequency of 2 Hz and an intensity of 2 mA will be established by SDZ II device.
Category
Rehabilitation
2
Description
Intervention group: Applying laser acupuncture in the form of 2 sessions a week for 4 weeks, each session will last 30 minutes, and during this time, the low-power laser will be placed on the LR3, ST36, PC6, PC5, and LI11 points. These points are bilaterally on the body, and the 500 milliwatt laser will be placed on each point for 3 minutes.
Category
Rehabilitation
3
Description
Control group: Taking medicines that are already taken by the patient and no change or intervention will happen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Sciences Research Center Clinic
Full name of responsible person
Majid Mohammadkhani
Street address
Mashahir Square towards Saadi Square, Research Center Clinic
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
majidmirmohammadkhani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hossein Ali Bakhshi
Street address
Kilometer 5, Damghan Road, University Educational Complex, first floor, west side of the main building
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3365 4180
Email
halibakhshi.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hamidreza Alibabaei
Position
Master's student in sports physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Pasteur Square, Western Pastor St., Agideh St., Guderzi Alley, Cambys Dead End, No. 2, Unit 2
City
Tehran
Province
Tehran
Postal code
1318845581
Phone
+98 21 6659 4170
Email
hamiddd.reza1378@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hamidreza Alibabaei
Position
Master's student in sports physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Pastor Square - Western Pastor St. - Agideh St. - Guderzi Alley - Cambys Dead End - No. 2 - Unit 2
City
Tehran
Province
Tehran
Postal code
1318845581
Phone
+98 21 6659 4170
Email
hamiddd.reza1378@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hamidreza Alibabaei
Position
Master's student in sports physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Pastor Square - Western Pastor St. - Agideh St. - Guderzi Alley - Cambys Dead End - No. 2 - Unit
City
Tehran
Province
Tehran
Postal code
1318845581
Phone
+98 21 6659 4170
Email
Hamiddd.reza1378@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It will be published as an article
When the data will become available and for how long
It will be published as an article
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
It will be published as an article
What processes are involved for a request to access data/document