Effect of electroacupuncture to GB44, TE21, ST36 and LR2 on pain and disability in migraineurs: A randomised placebo - controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Migraine Disability Assessment (MIDAS) Questionnaire
研究概览
简要总结
A randomized placebo- controlled trial will be adopted for the study. 50 patients will be recruited from Government Yoga and Naturopathy Medical College and Hospital and randomly divided into study and control group. The baseline assessments such as Migraine disability assessment (MIDAS) questionnaire as a primary outcome measure and Electroencephalogram (EEG) as a secondary outcome measure will be recorded for both the groups. For study group electroacupuncture will be given to four acupuncture points (GB44, TE21, ST36 and LR2) and in control group electroacupuncture will be given at four non-acupuncture points. Electrical stimulus to acupuncture and non- acupuncture points will be given using acupoint nerve stimulator (ACS acupressure stimulator TENS – 2 channel) with intermittent wave, frequency of 5Hz, current intensity adjusted according to patients’ tolerance with needle retention for 30 mins for 5 days per week for a total duration of 2 weeks. Post assessment will be taken after 2 weeks of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who confirm the diagnostic criteria for migraine stipulated by The International Classification of Headache Disorders, 3rd edition 2) Patients of Migraine with aura (MwA) and Migraine without aura (MwoA) 3) Patients not under drugs for migraine prophylaxis 4) Patients willing to take part in research and give written informed consent.
排除标准
- •Other primary and secondary types of headaches 2) Cerebral hemorrhage and vascular malformation 3) Stroke 4) Parkinson’s and other extrapyramidal diseases 5) History of epilepsy or any mental disorders 6) Intake of anti-psychotic or anti-depressant drugs 7) Neuralgia of face or head 8) Pregnancy, lactation or insufficient contraception 9) Immunodeficiency and bleeding disorders 10) Severe pain syndromes of cervical spine 11) Serious illness such as cancer 12) Patients with metal implants, pacemaker or prosthetics 13) Phobia to needling and electrical stimulation 14) Participation in any other clinical trial.
结局指标
主要结局
Migraine Disability Assessment (MIDAS) Questionnaire
时间窗: Migraine Disability Assessment (MIDAS) Questionnaire will be measured before and after 2 weeks of intervention
次要结局
- Electroencephalogram (EEG)(The changes in various frequency bands (alpha, beta, theta and delta) of cortical activity will be measured using EEG before and after 2 weeks of intervention)
研究者
Dr N Sheeja Begum
Government Yoga and Naturopathy Medical College and Hospital