Effectiveness of electroacupuncture and manual acupuncture in patients with tension-type headache: a randomized clinical trial

INTERVENTION: Intervention 1: First intervention group: electroacupuncture: after disinfecting the skin, disposable sterile needles size 25 X0.25 in points (GB20‐GV20‐LI4‐LV3‐E XHN 5‐ST8‐GB8‐SP6‐ST36‐E XHN 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‐E XHN 5‐ST8‐GB8‐SP6‐ST36‐E XHN 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. CONDITION: G44.2 Tension‐type headache. ; Tension‐type headache PRIMARY OUTCOME: Average duration of pain attacks. Timepoint: Every day, the hours that the patient had a headache are recorded. Method of measurement: Record the start and end time of the headache in the diary. Then the average is estimated in hours over 4 weeks. 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. Number of headache days. Timepoint: Daily. 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 every four weeks. INCLUSION CRITERIA: 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). SECONDARY OUTCOME: 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. 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 ques ions 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. 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.