Set Point Acupuncture for Migraines Using a Digital Assistant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- If a standard set of acupuncture points delivered over a set time frame, reduces the frequency and intensity of headaches in a population of migraine sufferers.
研究概览
简要总结
The object of this research study is to test a standardized set of acupuncture points on migraine patients to reduce frequency and intensity of headaches. Acupuncture has been studied in prior research but the treatment points have varied between subjects, making it difficult to replicate studies.
详细描述
Subjects will be recording daily headache activity on personal digital assistants (PDA's) for 12 weeks before and 12 weeks after 8 weeks of acupuncture intervention. MIDAS, HIT-6 and BDI-II measurements will be done at the beginning of the study (12 weeks pre-intervention), directly before the intervention, directly after, and 12 weeks post-intervention. Measurements will be compared before and after intervention. This is a follow-up to a successful earlier study when these same acupuncture points were used on subjects with chronic daily headache, the majority being migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between the ages of 21 years and 65 years of age
- •Subjects with a history of migraine headaches for at least 12 months
- •Subjects who have not received acupuncture for any medical condition in the past 6 months.
- •A negative pregnancy test for childbearing females since some acupuncture points may be contraindicated in pregnancy. Pregnancy tests will be conducted at MMC.
- •Subjects willing and able to use a PDA daily for data collection
排除标准
- •Subjects who plan to receive acupuncture treatment for any other type of medical condition while enrolled in this protocol
- •Subjects with the presence of organic pathology (i.e., brain tumor)
- •Subjects who have the presence of a systemic disorder or illness, including serious psychiatric illness
- •Subjects who began a new headache treatment less than two weeks before proposed enrollment date
- •Subjects who are pregnant, lactating, or planning to become pregnant within 6 months
- •Subjects that use alcohol on a regular basis
- •Subjects that use recreational drugs
- •Subjects that have a cardiac pacemaker
- •Subjects that use analgesics on more than 10 days per month
- •Subjects that exercise prophylactic headache treatment with drugs during the past 4 weeks
结局指标
主要结局
If a standard set of acupuncture points delivered over a set time frame, reduces the frequency and intensity of headaches in a population of migraine sufferers.
时间窗: 32 weeks
次要结局
- Measurements of the impact of acupuncture intervention will be detected when baseline measurements of frequency and severity of headaches is compared to measurements taken 12 weeks after the last acupuncture session. MIDAS, HIT-6, BDI-II and SF-12 scores(32 weeks)