Tension-type headache. Tension-type headache
Conditions
Interventions
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
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShirin Shafaee
Mashhad University of Medical Sciences
Outcome results
None listed