Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients : Study on Head Pain Characteristic and MIDAS-Ina Score
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Frequency of migraine attacks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with migraine
- •Minimum of 3 days of migraine attacks in 1 month
- •Willing to participate until the study concludes
排除标准
- •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
研究组 & 干预措施
Intervention Group
Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
干预措施: Lidocaine 2 % Pharmacopuncture (Device)
Control Group
Propranolol 20mg, twice daily for 28 day / 4 week
干预措施: propranolol 20mg (Drug)
结局指标
主要结局
Frequency of migraine attacks
时间窗: Before therapy, week 4, week 8
Frequency of migraine attacks in 1 month
Duration of migraine attacks
时间窗: Before therapy, week 4, week 8
Duration of migraine attacks, counted in hour
Intensity of migraine attacks
时间窗: 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
时间窗: 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
时间窗: week 4, week 8
Improvement of bothersome symptoms, measured as improved or not improved
Adverse Event Related to Intervention
时间窗: immediately post-intervention until 8 weeks
adverse event happening after intervention is given, including pain, infection, skin rash/irritation will be recorded and monitored
次要结局
未报告次要终点
研究者
Jeffry Alamsjah
Principal Inverstigator
Indonesia University