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

Determining the effectiveness of manual acupuncture and electroacupuncture on intensity and number of days of tension headaches, the amount of painkillers used in acute headaches, anxiety, depression and quality of life.

Clinical trial with control group, with parallel groups, single-blind study, randomized, phase 3 on 75 patients. The online site https://www.sealedenvelope.com was used for randomization.

Patients visit the acupuncture clinic of Imam Reza Hospital 3 times a week for 4 weeks. Disposable sterile needles, size 0.25 x 25 mm, are placed in the specified place and depth according to Chinese medicine reference books.. Both groups Patients receive 12 treatment sessions. The follow-up period is 8 weeks

Patients with tension headaches aged 18 to 65 years with the onset of headache under the age of 50, whose treatment started 3 months before the study and continued without any changes during the study. Exclusion criteria: Migraine headache more than one day a month or secondary headaches; severe physical or mental illness; pregnancy; breastfeeding; any type of addiction, acupuncture treatment in the last 6 months and continuous use of headache pain relievers more than 10 days a month for more than 3 months.

Needles will be inserted in these points for both intervention groups: GB20-GV20-LI4-LV3-EX HN 5-ST8-GB8-SP6-ST36-EX HN 3-SJ 5-LU 7-ST40-REN12-PC6-HT7-BL60. In the electro-acupuncture group, the needles are stimulated with an electro-acupuncture device at points DU 20/EX-HN3-LI4/PC 6-LIV 3/SP 6. Participants in the usual care group (control) continued their previous treatment and completed the questionnaires similarly to the two intervention groups.

Pain intensity

1- Sampling has not yet ended, the date has been modified 2- Except for the care provider and investigator who do not have the possibility of blinding in acupuncture studies, the others are blinded 3- In the primary outcome: section of headache hours, the word "average" in this section was incorrect and I delete it.4- The name of the person responsible for general inquiries is modified.

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.

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.