研究疾病:
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脑梗死后遗症导致肢体活动障碍
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研究疾病代码:
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Target disease:
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Sequela of cerebral infarction leads to limb movement disorder
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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传统针灸腧穴定位、行针手法依赖于医生的临床经验,医者不同治疗手段就不同,所造成的治疗效果也不同,具有不可重复性,缺少科学定量的分析,阻碍了针灸学术的发展和传承。超声“针灸”是传统针灸的一种创新应用,非“侵入式”的针灸方式,对机体无痛无创,其配合常规方法治疗心脑血管疾病效果显著[24,25],但目前采用单个元件通过物理方式实现声场聚焦,不能随意调节焦域模式,限制了其的深入研究,很难进入临床应用。超声波作为机械波,可以在频率、强度、空间区域等方面进行精确控制和计量。本项目利用超声相控阵通过电子控制实现声能在皮下聚焦的深度、角度和强度的任意调节准确模拟针灸手法,治疗手段可重复再现,治疗量效关系可科学评价,声学与中医学科交叉,为针灸现代化的研究提供了新思路、新方法、新手段,具有较深的科学意义和应用前景。本项目以超声“针灸”治疗脑梗死后遗症为切入点,通过肢体肌肉行为学、影像学、临床等不同层次进行针灸刺激量与治疗效果之间的量效关系研究,为脑梗死后遗症治疗提供了新的治疗手段,具有良好的社会效应。
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Objectives of Study:
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Traditional acupuncture and moxibustion acupoint positioning and acupuncture manipulation depend on doctors' clinical experience. Different treatment methods of doctors are different, resulting in different treatment effects, which are unrepeatable and lack of scientific and quantitative analysis, thus hindering the development and inheritance of acupuncture and moxibustion. Ultrasonic "acupuncture" is an innovative application of traditional acupuncture. It is a non-invasive acupuncture method, which is painless and non-invasive. It has a remarkable effect in treating cardiovascular and cerebrovascular diseases with conventional methods [24,25]. However, at present, focusing on sound field by physical means with a single element can not be adjusted at will, which limits its in-depth research and makes it difficult to enter clinical application. As a mechanical wave, ultrasonic waves can be accurately controlled and measured in frequency, intensity, spatial area and so on. In this project, the ultrasonic phased array is used to realize the arbitrary adjustment of the depth, angle and intensity of the subcutaneous focus of acoustic energy through electronic control, which accurately simulates the acupuncture technique. The treatment means can be reproduced repeatedly, the relationship between treatment dose and effect can be scientifically evaluated, and acoustics and traditional Chinese medicine disciplines cross, which provides new ideas, new methods and new means for the research of acupuncture modernization, and has deep scientific significance and application prospect. This project takes ultrasonic "acupuncture" as the breakthrough point to treat sequelae of cerebral infarction, and studies the dose-effect relationship between acupuncture stimulation amount and therapeutic effect through different levels of limb muscle behavior, imaging, clinical, etc., which provides a new therapeutic means for the treatment of sequelae of cerebral infarction and has good social effects.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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① 诊断为脑梗死后遗症导致肢体活动障碍,诊断标准参照《中风病诊断与疗效评定标准》[26]拟定。包括:① 主症:偏瘫、神识昏蒙、言语謇涩或不语、偏身感觉异常、口舌歪斜;② 次症:头痛、眩晕、饮水发呛、目偏不瞬、共济失调。结合头颅CT或MRI的检查结果而确诊。
② 凡符合以上脑梗死诊断标准,年龄为35-70岁。
③ 病程在1月以上(处于脑梗死恢复期或后遗症期),神志清醒。
④ 肌力在IV级以下,无严重心、肝、肾并发症及糖尿病患者。
⑤ 能够理解本试验的程序和方法,自愿严格遵守临床试验方案完成本试验,并签署知情同意书。
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Inclusion criteria
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① The diagnosis is limb movement disorder caused by sequela of cerebral infarction, and the diagnosis standard is drawn up according to the Standard for Diagnosis and Efficacy Evaluation of Stroke [26]. Including: ① The main symptoms: hemiplegia, mental confusion, unsmiling or mute speech, abnormal hemiparesis, and skewed tongue and mouth; ② Secondary symptoms: headache, dizziness, choking on drinking water, blindness, ataxia. Combined with the results of CT or MRI, the diagnosis was made. ② Those who meet the above diagnostic criteria of cerebral infarction are 35-70 years old. ③ The course of disease is more than one month (in the recovery period or sequela period of cerebral infarction), and he is conscious. ④ Muscle strength is below grade IV, and there are no serious heart, liver and kidney complications or diabetic patients. ⑤ Be able to understand the procedures and methods of this trial, voluntarily and strictly abide by the clinical trial scheme to complete this trial, and sign the informed consent.
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排除标准:
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① 排除意识生命体征不稳定的患者;
② 年龄在35岁以下或70岁以上患者;
③ 妊娠或哺乳期女性患者;
④ 未生育者及一年内计划怀孕者;
⑤ 装有心脏起搏器的患者;
⑥ 伴恶性肿瘤、精神病患者;
⑦ 伴有严重的心、脑、肾及造血系统疾病患者;
⑧ 试验过程中出现以下情况者:心肌梗死、严重/不稳定型心绞痛、冠状动脉/外周动脉旁路移植、心力衰竭、脑血管意外(包括短暂性脑缺血发作);以及癫痫、严重肝肾功能不全、机械性肠梗阻、心动过缓、支气管哮喘者等疾病;
⑨ 研究者认为具有任何可能导致受试者不能完成本研究或给受试者带来明显风险的其他任何情况。
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Exclusion criteria:
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① Exclude patients with unstable vital signs;
② Patients under 35 years old or over 70 years old;
③ Pregnant or lactating female patients;
④ Those who have not given birth and plan to be pregnant within one year;
⑤ Patients with cardiac pacemaker;
⑥ Patients with malignant tumor and psychosis;
⑦ Patients with severe heart, brain, kidney and hematopoietic system diseases;
⑧ During the test, the following cases occurred: myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass grafting, heart failure, cerebrovascular accident (including transient ischemic attack); And epilepsy, severe hepatic and renal insufficiency, mechanical intestinal obstruction, bradycardia, bronchial asthma and other diseases;
⑨ In the opinion of the researcher, there is any other situation that may cause the subjects to fail to complete the study or bring obvious risks to the subjects.
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研究实施时间:
Study execute time:
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从From
2020-01-01
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-01-10
至To
2022-12-31
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