Investigating the effectiveness of two different groups of acupressure points through dedicated mobile phone applications in migraine control
Design
Acupressure training is done in the video attached to the application.
The randomization of 2 groups is done by the http://random.org system located in the system.
The pressure of each of the 4 points is 3 minutes with 1 minute of rest between the points.
The intervention is once a day and the duration of the intervention is 1 month.
The patient's symptoms will be registered daily in the system.
Forms are completed 3 times before the intervention, immediately after the intervention and 3 months after the intervention.
Resolving ambiguities by contacting the student's cell phone, which is stated in the informed consent form.
Settings and conduct
Self-care at the patient's home.
Participants/Inclusion and exclusion criteria
Migraine patients with compliance with entry and exit criteria
Intervention groups
Intervention group points: GV-20, BL-2, EX-HN5, LI-4
Points of the control group: LU-7, GB-21, ST-36, , TW-17
Main outcome variables
Pain severity, pain frequency in every month, pain duration
General information
Reason for update
Acronym
Acupreesure for migraine
IRCT registration information
IRCT registration number:IRCT20121228011912N6
Registration date:2023-05-15, 1402/02/25
Registration timing:registered_while_recruiting
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Hamidreza Bahrami Taghanaki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 5666
Email address
bahramihr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of app-based acupressure therapy in patients with migraine pain in
Public title
Survey the effect of app-based acupressure therapy in patients with migraine pain in Mashhad population
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Previous and definitive diagnosis of migraine (without aura) by a neurologist based on the criteria of the international association of Headache ( IHS) at least 6 months ago (upload the latest prescription for migraine treatment by a neurologist)
Experiencing acute migraine at a frequency of 2-8 times per month for the previous 3 months
Being in the age range of 18-45 years
Absence of pregnancy and breastfeeding
Absence of other neurological diseases
Absence of cancer and skin malignancy or wound in the acupressure area
All eligible participants must be able to understand the research instructions and be willing to give informed consent.
All participants should answer and complete the entire designed questionnaires
All participants should provide a daily report of the severity, duration, and number of migraine attacks
Exclusion criteria:
A headache that has an organic cause (Subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis), vascular malformations, temporal artery arthritis, high blood pressure, or having another neurological disease for headache are excluded from the study.
Participants who had received headache prophylaxis treatment during the previous 3 months
Participants who (women) intend to get pregnant during the study
Non-cooperation of the patient (failure to perform intervention more than 8 times)
Changing the type and dosage of drugs used during the intervention
Has used acupuncture or acupressure in the last 6 months
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
The website https://www.random.org/ will be used to generate random numbers. The randomization ratio will be one to one. Random numbers will be transferred to the specially created software and will be assigned to study groups completely randomly when users log in.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the participants entered the desired application and registered and answered the questionnaires, and if they met the criteria for entering the study, using the application software, they were randomly assigned in an equal ratio of 1:1 (n1 = 76 and n2 = 76) between the groups. This study will be conducted in a randomized double-blind manner (participants and analysts are blind in this study).
Patients in the two acupressure groups will be blinded to the type of treatment received, and patients will be blinded to whether they are in a group receiving different acupressure points. Also, the study analyst was also blind and without information regarding the type of treatment group, which disease received which type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
In order not to be deprived of the standard treatment of classical medicine, patients should be treated by one of the standard methods of migraine by a neurologist.Then, after random grouping and compliance with medical ethics standards, both groups will have real acupuncture points leading to more and less effect. that the treatment will be carried out as self-care acupressing and after making sure to learn the taught items through the mobile phone application by the patient himself.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Science
Street address
3rd floor - Abuzar qafari Bulv - Abuzar qafari 38- Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176716584
Approval date
2022-11-19, 1401/08/28
Ethics committee reference number
IR.MUMS.REC.1401.286
Health conditions studied
1
Description of health condition studied
Migraine Headache
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
Primary outcomes
1
Description
pain severity
Timepoint
Before the intervention and 1 and 3 months after the intervention
Method of measurement
Using visual analogous scale (VAS)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and 1 and 3 months after the intervention
Method of measurement
WHO quality of life-BREF 26 questionnaire
Intervention groups
1
Description
The intervention is acupressure, which is one of the therapeutic branches of Chinese medicine. Acupressure is pressure on specific points of the body, which are acupuncture points, by thumb pulp and with vertical pressure on the surface of the patient's body. The amount of pressure is such that the patient gets as close as possible to the bone below that point and feels pain. The treatment protocol consists of pressing each point for 3 minutes, and since we use 4 points, a total of 12 minutes in each patient's self-treatment session. One treatment session per day and the duration of the treatment is 1 month. In this study, 4 mentioned acupuncture points are used for the intervention group. GV-20, BL-2, EX-HN 5, LI-4
Category
Treatment - Other
2
Description
The same explanation given regarding intervention group 1 is also applicable in this group. But the points that are used in the control group are different and they are: LU-7, GB-21, ST-36, TW-17
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک طب سوزنی بیمارستان امام رضا (ع) مشهد
Full name of responsible person
دکتر محمد جواد باقری
Street address
Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13316
Phone
+98 51 3854 3031
Fax
+98 51 3854 3038
Email
imamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Bahrami-Taghanaki
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9184166750
Phone
+98 51 3884 8931
Email
bahramihr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Bahrami-Taghanaki
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9184166750
Phone
+98 51 3841 1538
Email
bahramihr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Bahrami-Taghanaki
Position
ّFaculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Imam Reza Hospital - Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9184166750
Phone
+98 51 3841 1538
Email
bahramihr@mums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The statistical details of the data will be mentioned in the published article.
When the data will become available and for how long
After finishing research
To whom data/document is available
All those who have access to the published article or with the supervisory permission of the Vice Research of Mashhad University of Medical Sciences
Under which criteria data/document could be used
With the request of the responsible researcher and the consent of the University Research Council and only for survey purposes without any possibility of exploiting the content of the data.
From where data/document is obtainable
After printing the article to the responsible author and before printing, if required by relevant authorities, to the responsible researcher
What processes are involved for a request to access data/document
By means if Vice research of Mashhad University of Medical Science