Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients

Not Applicable

Not yet recruiting

• Conditions: Migraine
• Interventions: Device: Lidocaine 2 % Pharmacopuncture; Drug: propranolol 20mg

• Registration Number: NCT07067853
• Lead Sponsor: Indonesia University

Brief Summary

The goal of this clinical trial is to learn if 2% Lidocaine pharmacopuncture at the GB20 acupoint can effectively and safely treat migraine in adult patients. The main questions it aims to answer are:

* Does 2% Lidocaine pharmacopuncture at GB20 reduce the frequency of migraine attacks more than 40mg propranolol?

* Does 2% Lidocaine pharmacopuncture at GB20 reduce the duration of migraine attacks more than 40mg propranolol?

* Does 2% Lidocaine pharmacopuncture at GB20 reduce the intensity of migraine pain more than 40mg propranolol?

* Does 2% Lidocaine pharmacopuncture at GB20 improve MIDAS-Ina scores more than 40mg propranolol?

* Is 2% Lidocaine pharmacopuncture at GB20 more effective in improving bothersome migraine symptoms compared to 40mg propranolol?

* What is the incidence of side effects of 2% Lidocaine pharmacopuncture at GB20 in migraine patients?

Researchers will compare a pharmacopuncture group to a conventional medication group (propranolol) to see if pharmacopuncture works as an effective and safe alternative treatment for migraine patients.

Participants will:

* In the pharmacopuncture group, receive weekly injections of 0.5cc of 2% Lidocaine at the GB20 acupoint (bilaterally) for four weeks. These injections will be guided by ultrasonography.

* In the medication group, receive 20mg propranolol tablets twice daily for 28 days.

* Be provided with 500mg Paracetamol tablets as abortive therapy for acute migraine attacks.

* Use the 'Guardian Headache Diary' application to record migraine attack data (frequency, duration, intensity) for two months.

* Complete the MIDAS-Ina questionnaire at the beginning of the study, at the end of week 4, and at the end of week 8.

Side effects will be monitored and recorded throughout the study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Start: 2025-09-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosed with migraine
• Minimum of 3 days of migraine attacks in 1 month
• Willing to participate until the study concludes

Exclusion Criteria

• Headache with other known cause (e.g. head trauma, cancer, hemorrhagic stroke)
• Inaccessible GB20 acupuncture point (scar tissue, infection, open wound, etc)
• History of heart disease and/or asthma
• History of Hypersensitivity with propranolol and/or lidocaine
• History of acupuncture treatment 3 month prior to study
• Routine consumption of anticoagulation medications, steroids or pain killers
• Pregnant and breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Lidocaine 2 % Pharmacopuncture	Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
Control Group	propranolol 20mg	Propranolol 20mg, twice daily for 28 day / 4 week

Primary Outcome Measures

Name	Time	Method
Frequency of migraine attacks	Before therapy, week 4, week 8	Frequency of migraine attacks in 1 month
Duration of migraine attacks	Before therapy, week 4, week 8	Duration of migraine attacks, counted in hour
Intensity of migraine attacks	Before therapy, week 4, week 8	intensity of migraine attacks, measured with numeric rating scale from 1 to 10
MIDAS-Ina Score	Before therapy, week 4, week 8	Disability caused by migraine will be assessed with Migraine Disability Assessment Test - Indonesian Language (MIDAS-Ina), a 5-question questionnaire
Bothersome Symptom Improvement	week 4, week 8	Improvement of bothersome symptoms, measured as improved or not improved
Adverse Event Related to Intervention	immediately post-intervention until 8 weeks	adverse event happening after intervention is given, including pain, infection, skin rash/irritation will be recorded and monitored

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia