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

U

University of Indonesia (UI)

Status

Begins enrollment in 1 month

Conditions

Migraine

Treatments

Device: Lidocaine 2 % Pharmacopuncture
Drug: propranolol 20mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07067853
25-07-0995

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jeffry Alamsjah

Data sourced from clinicaltrials.gov

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