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IRCT20230626058585N1 IRCT 2023-10-17 Mashhad University of Medical Sciences Investigating the effect of acupuncture on headache Effectiveness of electroacupuncture and manual acupuncture in patients with tension-type headache: a randomized clinical trial 2023-10-17 anticipated 75 Complete https://irct.ir/trial/72759 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: However, due to the fact that we do not have any intervention in the control group, we do not have blinding. But in order to know whether electroacupuncture is superior to manual acupuncture or not, blinding will be done in the intervention groups, so that in both groups, the electrodes are connected to the needles, but in the manual acupuncture group, there is no current in wire and only the blinking diode that simulates the electric stimulus can be seen and its sound can be heard, Randomization description: Blocked individual using the online site https://www.sealedenvelope.com random allocation into three groups A (electroacupuncture), group B (manual acupuncture) and group C (usual care). Randomization will be done based on Block Randomization with blocks of 6. A block size of 6 will be used for random allocation. The prepared blocks will be placed inside the envelope. According to the order of arrival of patients, one of the envelopes will be randomly selected and based on the obtained blocks, patients will be allocated to groups. Allocation Concealment method: Using sealed and waxed opaque envelopes: In this way, the envelopes will be prepared and printed by one of the team members and random numbers will be placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then, first, the purpose of the study is explained to the person who meets the stated conditions, and if the person wishes, he signs the informed consent form and takes an envelope, then opens it and enters one of the three groups based on the contents of the envelope, Blinding description: 1- in order to know whether electroacupuncture is superior to manual acupuncture or not, blinding will be done in the intervention groups, so that in both groups, the electrodes are connected to the needles, but in the manual acupuncture group, there is no current in wire and only the blinking diode that simulates the electric stimulus can be seen and its sound can be heard. 2- Those who collect and analyze the information and the safety monitoring board do not know the names of the patients and the division of the groups and the assignment of each patient to each group. 3 Tension-type headache. Intervention 1: First intervention group: electroacupuncture: after disinfecting the skin, disposable sterile needles size 25 x 0.25 in points (GB20-GV20-LI4-LV3-EX HN 5-ST8-GB8-SP6-ST36-EX HN 3-SJ 5 -LU 7-ST40-REN12-PC6-HT7-BL60) with a certain depth based on the instructions of Chinese medicine ،are placed on both sides. The needles remain in place for 30 minutes. The needles are connected to the electro device in the distal points of both hands and feet and a local point and are stimulated for 30 minutes. The points that are connected to the electro include: DU 20 /EX-HN3 in head- LI4 / PC 6 in both hands - in both legs LIV 3 / SP 6. Intervention 2: The second intervention group: manual acupuncture - needles in points (GB20-GV20-LI4-LV3-EX HN 5-ST8-GB8-SP6-ST36-EX HN 3-SJ 5-LU 7-ST40-REN12-PC6-HT7- BL60) with a certain depth according to Chinese medicine instructions, will be placed on both sides and will remain in place for 30 minutes. In order to blind the electrodes, they are connected to the needles, but the passage of the electric current is interrupted and only the flashing diode that simulates the electric stimulus can be seen and its sound can be heard. Intervention 3: Control group: The participants in the usual care group continued their previous treatment without any intervention and completed the questionnaires similar to the two intervention groups. After the follow-up period, as a reward, they were treated with acupuncture with or without electro, based on the treatment result. will be placed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Shirin Shafaee
School of Persian and Complementary medicine, Campus of Ferdowsi University, Azadi Square
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3884 8930 shafaeish4001@mums.ac.ir Mashhad University of Medical Sciences scientific Seyyed Kazem Farahmand
School of Persian and Complementary medicine, Campus of Ferdowsi University, Azadi Square
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3884 8930 farahmandk1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients suffering from chronic and episodic tension headache based on the criteria of the International Headache Society (ICHD 3beta) who suffer from headache for more than one year. Age 18 to 65 years Age of onset of headache below 50 years Desire to participate in the study and sign an informed consent Any headache treatment should be started at least 3 months before the study and continued without any changes (except the treatment of acute headache attack) in the last 3 months and during the intervention and follow-up period. These treatments include pain relievers when needed (such as acetaminophen and ibuprofen) and/or preventive medications (such as amitriptyline) or even non-pharmacological treatments (such as relaxation techniques). 18 years 65 years Both Suffering from migraine headache for more than one day in a month Secondary headaches related to organic disease (for example: cerebral hemorrhage, cerebral thrombosis, vascular malformation, hypertension) Severe physical or mental illness such as seizures, coagulation disorders, heart disease, liver disease, kidney disease and other organs. Pregnancy, breastfeeding or decision to become pregnant during the study period Addiction to smoking, alcohol, drugs Acupuncture treatment in the last 6 months (in order to blind the treatment method, he has never had a history of electro-acupuncture) Continuous use of headache pain relievers more than 10 days a month for more than 3 months (Medication-overuse headache) G44.2 Tension-type headache Treatment - Devices Treatment - Devices Other First intervention group: electroacupuncture: after disinfecting the skin, disposable sterile needles size 25 x 0.25 in points (GB20-GV20-LI4-LV3-EX HN 5-ST8-GB8-SP6-ST36-EX HN 3-SJ 5 -LU 7-ST40-REN12-PC6-HT7-BL60) with a certain depth based on the instructions of Chinese medicine ،are placed on both sides. The needles remain in place for 30 minutes. The needles are connected to the electro device in the distal points of both hands and feet and a local point and are stimulated for 30 minutes. The points that are connected to the electro include: DU 20 /EX-HN3 in head- LI4 / PC 6 in both hands - in both legs LIV 3 / SP 6 The second intervention group: manual acupuncture - needles in points (GB20-GV20-LI4-LV3-EX HN 5-ST8-GB8-SP6-ST36-EX HN 3-SJ 5-LU 7-ST40-REN12-PC6-HT7- BL60) with a certain depth according to Chinese medicine instructions, will be placed on both sides and will remain in place for 30 minutes. In order to blind the electrodes, they are connected to the needles, but the passage of the electric current is interrupted and only the flashing diode that simulates the electric stimulus can be seen and its sound can be heard. Control group: The participants in the usual care group continued their previous treatment without any intervention and completed the questionnaires similar to the two intervention groups. After the follow-up period, as a reward, they were treated with acupuncture with or without electro, based on the treatment result. will be placed Average tension headache intensity over 4 weeks. Timepoint: Initially before randomization and 4, 8, 12, weeks after randomization. Method of measurement: Using a visual analog scale (VAS ) includes a straight horizontal line marked from 0-10. 0 means no pain and 10 means very severe pain. The participants are asked to Answer the question: How severe was your worst pain in the past 24 hours?, and then mark the point on the line that corresponds to the pain level. The dosage of painkillers for acute headache attacks. Timepoint: Total dose consumed during 4 weeks (time interval: initially before randomization, 4, 8, 12 weeks after randomization). Method of measurement: The name, number and dose of acute pain reliever are recorded every day, the total dosage is checked every 4 weeks. Assessment of quality of life. Timepoint: At baseline before randomization, 4, 8, 12 weeks after randomization. Method of measurement: Using a 36-item short form survey instrument (SF-36) questionnaire that is used to evaluate people's quality of life, which includes 36 questions for physical and mental health, which are divided into 0-100 scores (0 = worst health condition and 100 = best health condition). .. The average score of 50 is expressed as the normative value for all scales. Assessment of anxiety score. Timepoint: At baseline before randomization, 4, 8, 12 weeks after randomization. Method of measurement: Beck's anxiety questionnaire. Assessment of depression status. Timepoint: At baseline before randomization, 4, 8, 12 weeks after randomization. Method of measurement: Beck depression questionnaire. Number of headache days. Timepoint: It will be daily recorded by patients. For statistical analysis: Initially, before randomization, and 4, 8, 12 weeks after randomization. Method of measurement: Headaches lasting more than 30 minutes per day are recorded in the headache diary. The response rate is defined as a reduction of more than 50% in the number of headache days. Duration of pain attacks. Timepoint: Every day, the hours that the patient had a headache are recorded. for statistical analysis: Initially before randomization and 4, 8, 12, weeks after randomization. Method of measurement: By recording the start and end time of the headache in the diary, the total pain hours in 4 weeks will be calculated. Mashhad University of Medical Sciences Approved 2023-09-09 Ethics committee of mashhad university of medical sciences Building number one of Mashhad University of Medical Sciences (Qureshi), in front of University 18, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)