The Comparsion of Primary Headache in Blood Test of MMP2 and CGRP: A Single Blind Randomized Sham-laser-acupuncture Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cGRP
研究概览
简要总结
Aims:
To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.
Methods:
In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep.
In addition, patients' characteristics will be investigated as follows:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.
Importance:
In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.
详细描述
Headache is one of the most common complaints encountered in medical institution as known as an almost universal human experience. Approximately 65% of headaches are classified as primary, which was a composite of migraine, tension-type headache, trigeminal autonomic cephalalgia and other primary headaches according to the third edition of the International Classification of Headache Disorders (ICHD-3). Primary headaches encompass a heterogeneous group of neurologic disorders and might be bothersome for patients.
It's well established that acupuncture can be considered a treatment option for migraine prevention. The efficacy of laser-acupuncture is similar to acupuncture, and laser-acupuncture is a non-invasive therapeutic approach and safety. It could reduce the risk of hemorrhage, infection and needle phobia. However, the efficacy of laser-acupuncture in primary headache remains inconclusive.
MMP2, CGRP, substance P, beta-endorphin are new Lab examination for following up the patients suffered from migraine.
Aims:
To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants were randomized by computer software (Excel 2016 for Windows) and the randomization process was overseen by the Institutional Review Board at Taichung Veterans General Hospital. All the participants and our collaborative case-manager were blinded to treatment types.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine patient under the diagnosis and classification of headache was evaluated using the ICHD-3 criteria.
排除标准
- •Age under 18 years old
- •Pregnancy
结局指标
主要结局
cGRP
时间窗: 12 weeks, 24 weeks, 36 weeks
change in cGRP from baasline and each follow-up time point
MMP2
时间窗: 12 weeks, 24 weeks, 36 weeks
change in MMP2 from baasline and each follow-up time point
次要结局
- Difference in the number of headache days per month(12 weeks, 24 weeks, 36 weeks)
- Difference in the of headache attacks lasting hours per month(12 weeks, 24 weeks, 36 weeks)
- Difference in the headache pain intensity (NRS)(12 weeks, 24 weeks, 36 weeks)
- Difference in the number of days with acute headache medication intake per month(12 weeks, 24 weeks, 36 weeks)
- Difference in the Migraine Disability Assessment(12 weeks, 24 weeks, 36 weeks)
- Difference in the Beck's Depression Inventory(12 weeks, 24 weeks, 36 weeks)
- Difference in the Hospital Anxiety and Depression Scale(12 weeks, 24 weeks, 36 weeks)
- 30% reduction in migraine days(12 weeks, 24 weeks, 36 weeks)
- Substance P(12 weeks, 24 weeks, 36 weeks)
- beta-endorphin(12 weeks, 24 weeks, 36 weeks)