Migraine
Conditions
Keywords
Migraine, Acupuncture
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.
Interventions
DEVICELidocaine 2 % Pharmacopuncture
Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
DRUGpropranolol 20mg
Propranolol 20mg, twice daily for 28 day / 4 week
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The intervention group will receive pharmacopuncture, while the control group will receive propranolol tablets
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Migraine Disability Assessment Test - Indonesian Language (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 with a minimum score of 0 and maximum score of 450. Higher score means worse outcome. |
| 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 |
Countries
Indonesia
Outcome results
None listed