Investigating the effect of acupuncture on headache

Phase 3

Recruiting

• Conditions: Tension-type headache.; Tension-type headache; G44.2

• Registration Number: IRCT20230626058585N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.