Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- National Institute of Health Stroke Scale
研究概览
简要总结
Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.
详细描述
Stroke is a major cause of death and disability. According to the Ministry of Health and Welfare in Taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in Taiwan in 2020. Stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. Therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. This study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. Subjects will be divided into two main groups by random assignment. The intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). The treatment frequency was 3 times a week for at least one week. Consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemorrhagic stroke by a specialist
- •Age over 20 years and below 85 years
- •GCS between 5-13
排除标准
- •Intracranial hemorrhage resulted from vascular anomalies
- •Pregnant patients
- •Intracranial tumor related hemorrhage
- •Other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury
- •Organ damage or terminal illness (heart or kidney failure or malignancy)
结局指标
主要结局
National Institute of Health Stroke Scale
时间窗: 3 weeks and follow-up for one year
The total NIHSS score can range from 0 to 42, where a score of 0 means no stroke symptoms, and a higher score indicates a more severe stroke.
Glasgow Coma Scale(GCS)
时间窗: 3 weeks and follow-up for one year
The Glasgow Coma Scale(GCS) is a clinical scale used to reliably measure a person's level of consciousness. The total score can range from 3 to 15, and the lower scores mean the worse outcome.
Karnofsky Performance Scale
时间窗: 3 weeks and follow-up for one year
The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Barthel Index
时间窗: 3 weeks and follow-up for one year
The Barthel Index is a scale used to measure performance in activities of daily living (ADL). The total score can range from 0 (complete dependence) to 100 (complete independence), providing a quantitative measure of an individual's functional independence.
Muscle Power
时间窗: 3 weeks and follow-up for one year
Muscle power is often assessed using a grading system. The most common is the Medical Research Council (MRC) Scale, which grades muscle strength on a scale from 0 to 5 and the lower scores mean the worse outcome.
The Modified Rankin Scale
时间窗: 3 weeks and follow-up for one year
The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome.
次要结局
- C reactive protein (CRP)(3 weeks and follow-up for one year)
- Albumin(3 weeks and follow-up for one year)
- Creatinine(3 weeks and follow-up for one year)
- White blood cells differential count(3 weeks and follow-up for one year)
- Sodium(3 weeks and follow-up for one year)
- Completed blood count (CBC)(3 weeks and follow-up for one year)
- Potassium(3 weeks and follow-up for one year)
- Pulse analysis system (PPAS-96)(Sphygmography)(3 weeks and follow-up for one year)
- Blood urea nitrogen (BUN)(3 weeks and follow-up for one year)