A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis: a Single-center, Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Score of MDS Unified-Parkinson Disease Rating Scale III
研究概览
简要总结
The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with bradykinesia, combined with resting tremor and/or myotonia.
- •Appendix CT suggested chronic appendicitis evaluated by two experienced experts.
- •All subjects and their guardians give informed consent to the content of this study and sign informed consent.
- •Normal coagulation function.
- •If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment.
排除标准
- •Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism.
- •Neuroimaging examination of presynaptic dopaminergic system function was normal.
- •Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment.
- •Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed.
- •People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V.
- •Complicated with serious systemic diseases, disorders of consciousness, stroke, serious coronary heart disease, diabetes, liver and kidney diseases, and serious visual and hearing disorders.
- •Patients with severe organic or functional dysphagia;Those who were deemed by the researcher to be unable to complete the visit and auxiliary examination as required by the study protocol.
结局指标
主要结局
Score of MDS Unified-Parkinson Disease Rating Scale III
时间窗: 3 month
The changes of MDS-UPDRS III scores before and after acupuncture treatment were compared.The lowest score was 0 and the highest was 132, with higher scores indicating more severe symptoms.
次要结局
未报告次要终点