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

December 30, 2025 updated by: Jeffry Alamsjah, Indonesia University

Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients : Study on Head Pain Characteristic and MIDAS-Ina Score

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
Device: Lidocaine 2 % Pharmacopuncture
Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
Active Comparator: Control Group
Propranolol 20mg, twice daily for 28 day / 4 week
Drug: propranolol 20mg
Propranolol 20mg, twice daily for 28 day / 4 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of migraine attacks
Time Frame: Before therapy, week 4, week 8
Frequency of migraine attacks in 1 month
Before therapy, week 4, week 8
Duration of migraine attacks
Time Frame: Before therapy, week 4, week 8
Duration of migraine attacks, counted in hour
Before therapy, week 4, week 8
Intensity of migraine attacks
Time Frame: Before therapy, week 4, week 8
intensity of migraine attacks, measured with numeric rating scale from 1 to 10
Before therapy, week 4, week 8
Bothersome Symptom Improvement
Time Frame: week 4, week 8
Improvement of bothersome symptoms, measured as improved or not improved
week 4, week 8
Adverse Event Related to Intervention
Time Frame: immediately post-intervention until 8 weeks
adverse event happening after intervention is given, including pain, infection, skin rash/irritation will be recorded and monitored
immediately post-intervention until 8 weeks
Migraine Disability Assessment Test - Indonesian Language (MIDAS-Ina) Score
Time Frame: 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 with a minimum score of 0 and maximum score of 450. Higher score means worse outcome.
Before therapy, week 4, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Komite Etik Penelitian Kesehatan FKUI-RSCM, Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

July 14, 2025

First Submitted That Met QC Criteria

July 14, 2025

First Posted (Actual)

July 16, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-07-0995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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