A Randomized Trial to Explore the Efficacy of Stellate Ganglion Block in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Penetration-Aspiration Scale
研究概览
简要总结
The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.
Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
详细描述
Dysphagia, or swallowing difficulty, is a common symptom associated with Parkinson's disease. It is characterized by weakened chewing and throat muscles, leading to difficulties in eating, coughing, and a sensation of choking in individuals with Parkinson's disease.
The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.
Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
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 (Investigator, Outcomes Assessor)
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
- •Age >18 years.
- •Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in
- •Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- •Stable vital signs, conscious, able to cooperate with assessment and treatment.
排除标准
- •Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- •History of mental diseases or use of antipsychotics.
- •Complicated with cognitive impairment or consciousness dysfunction.
- •Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
结局指标
主要结局
Penetration-Aspiration Scale
时间窗: day 1 and day 20
On the day 1 and day 20, Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases.The scores rang from 0 to 8
次要结局
- Swallowing duration(day 1 and day 20)
- Modified Barthel Index(day 1 and day 20)
- Functional Oral Intake Scale(day 1 and day 20)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University