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NCT Number: NCT07067853

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine 2 % Pharmacopuncture

Device

Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week

propranolol 20mg

Drug

Propranolol 20mg, twice daily for 28 day / 4 week

Primary outcomes

  1. Frequency of migraine attacks

    Time frame: Before therapy, week 4, week 8

    Frequency of migraine attacks in 1 month

  2. Duration of migraine attacks

    Time frame: Before therapy, week 4, week 8

    Duration of migraine attacks, counted in hour

  3. 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

  4. 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.

  5. Bothersome Symptom Improvement

    Time frame: week 4, week 8

    Improvement of bothersome symptoms, measured as improved or not improved

  6. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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