Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Neurological examination( clinical signs of stroke)
研究概览
简要总结
The study will make an association between the diagnosis of traditional Chinese medicine that establishes that the syndrome of blood stagnation generates alteration in blood flow, vascular dysfunction, and damage to the endothelium. This process is like what occurs in a stroke. It will use electroacupuncture to change this chronic inflammatory process, and to know the effects and efficacy of this technique in the regulation and modulation of to treat extensive inflammatory diseases. However, this inflammatory response must be associated with serum cholesterol levels, since they are associated with a stroke between the LDL-C/HDL-C ratio and the prognosis after a stroke.
详细描述
An adequate early standardized diagnosis of ischemic stroke uses different treatment protocols for these patients, depending on their complexity. Therapeutic windows have been associated with better outcomes when reperfusion or recanalization occurs. Someone has shown strongly related clinical outcome in ischemic stroke to the timely revascularization benefit of acupuncture in stroke patients; electroacupuncture intervention on metabolism is associated with effects on the anti-inflammatory mechanism and metabolic modulation, effects of electroacupuncture stimulation at different spinal segmental levels in a rat model of diabetes mellitus, and another vascular effect of electroacupuncture generate the modulation of the elasticity of the blood vessels.
Electroacupuncture (EA) stimulation is commonly applied in the treatment of ischemic stroke in the clinic. The efficacy of EA is associated with the acupuncture points, intensity, intervals, and duration of the intervention of the treatment for stroke.
The inflammatory response might be associated with serum cholesterol levels since they are associated with a stroke between the LDL-c/HDL-c ratio and the prognosis after a stroke. This study evaluates the impact of electroacupuncture as a modifier of total cholesterol, HDL-c, and LDL-c blood levels and its anti-inflammatory effect in patients with cerebrovascular accidents. Measurement of the post-electroacupuncture serum level (total cholesterol, HDL-c, LDL-c, and triglycerides) will provide adequate information on the influence that these risk factors have on blood vessels and vascular endothelium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients and outcomes assessors were blind to group allocation
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute ischemic stroke from (ICD10 diagnostic code I63 - I66) First-time ischemic stroke diagnosis: confirmed with scanner (TC) and magnetic resonance (MRI) Stable hemodynamic indices according to safety standards in patients with ischemic stroke.
- •The age is between 35 and 80 years old.
排除标准
- •Hemorrhagic stroke (diagnostic I61 to diagnostic code I61.9) Cancer patients Recent event trauma requiring hospitalization Patients undergoing immunosuppressive therapy. Drug dependence and abuse. Pregnancy or fertility treatment Required pacemakers.
研究组 & 干预措施
Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites
the disproportionate inflammatory response presented by chronic and acute inflammation as is the case in patients with stroke. In addition, the evaluation of the risk factors associated with the presence of metabolites such as cholesterol and fatty acids will provide us with an adequate diagnosis of the influence that these risk factors have on the blood vessels and the vascular endothelium.This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length.
干预措施: electroacupuncture (Device)
The design and conduct randomized clinical trial using electroacupunture
efficacy and effectiveness of electroacupuncture in a clinical trial in electroacupuncture: design of control group and treatment group (including sharm acupuncture) and develop in this study the measurements in the patients and perform everything to the highest standards in both treatment procedures and measurement of results. Randomized controlled trail: intervention strategy and implementation.Also called Sham because it does not receive real stimulation from an acupuncture point, it is 1 cm away from the meridian. All procedures were carried out to a depth of 0.5 cm with disposable needles
干预措施: electroacupuncture (Device)
Arm type Methodological challenge in design
Electroacupuncture treatment, develops different groups study are three; electroacupuncture group or real treatment,1st control group or Participants in the sham group also received 24 sessions of acupuncture treatment; however, needling was performed 1 cm away from the real acupoints and 2nd control group or non-penetration needles. Access to medical records; to collect data and store it securely and anonymously.this group will receive treatment at 6 acupuncture points, but without penetration, without electroacupuncture, this is why it is called the control group. Use disposable needles too
结局指标
主要结局
Neurological examination( clinical signs of stroke)
时间窗: This assessment can be used before and after the electroacupuncture treatment period (1 week, 2 weeks, 4 weeks) stroke patient's ability and independence to care for themselves
National Institutes of Health Stroke Scale (NIHSS) score of 0\~40. Barthel Index (BI) score of:0\~100.The National Visual Analog Scale (VAS) score of: 0\~10.
次要结局
- Blood sample: comparable laboratory results:(First blood sample take at the time of admission, second blood sample taken, completed electroacupuncture treatment 2 weeks, and control 4 weeks)
研究者
Yu-Chen Lee
Chief and Attending Physician, Department of Acupuncture, China Medical University Hospital, Taichung, Taiwan.
China Medical University Hospital