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IRCT20121228011912N6 IRCT 2023-05-15 Mashhad University of Medical Sciences Survey the effect of app-based acupressure therapy in patients with migraine pain in Mashhad population Acupreesure for migraine Survey the effect of app-based acupressure therapy in patients with migraine pain in 2023-04-04 anticipated 152 Complete https://irct.ir/trial/68484 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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 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. 3 Migraine Headache. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The statistical details of the data will be mentioned in the published article. When: After finishing research To whom: All those who have access to the published article or with the supervisory permission of the Vice Research of Mashhad University of Medical Sciences Conditions: 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. Where to obtain: After printing the article to the responsible author and before printing, if required by relevant authorities, to the responsible researcher How to obtain: By means if Vice research of Mashhad University of Medical Science Comments:
public Dr. Hamidreza Bahrami-Taghanaki
Ebne Sina Street
Mashhad Iran (Islamic Republic of) 9184166750 +98 51 3884 8931 bahramihr@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Hamidreza Bahrami-Taghanaki
Ebne Sina street
Mashhad Iran (Islamic Republic of) 9184166750 +98 51 3841 1538 bahramihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Both 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 G43.0 Migraine without aura Treatment - Other Treatment - Other 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 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 Pain severity. Timepoint: Before the intervention and 1 and 3 months after the intervention. Method of measurement: Using visual analogous scale (VAS). 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. Mashhad University of Medical Sciences Approved 2022-11-19 Research Ethics Committees of Mashhad University of Medical Science 3rd floor - Abuzar qafari Bulv - Abuzar qafari 38- Ahmad Abad Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)