Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Drooling amount
研究概览
简要总结
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.
详细描述
Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.
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
- Quadruple (Participant, Care Provider, 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.
研究组 & 干预措施
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Comprehensive rehabilitation (Behavioral)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Stellate ganglion block (Procedure)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Lidocaine hydrochloride (Drug)
Comparator: Comprehensive rehabilitation+placebo
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Comprehensive rehabilitation (Behavioral)
Comparator: Comprehensive rehabilitation+placebo
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Placebo injection (Procedure)
结局指标
主要结局
Drooling amount
时间窗: day 1 and day 10
All participants' saliva was collected within 5 minutes into a cup, followed by the comparison of saliva quantity, composition 1 hour before noon, the amount will be recorded.
次要结局
- Modified Barthel Index(day 1 and day 10)
- Patient Health Questionnaire-9(day 1 and day 10)
研究者
Babujinaya Cela
Research Director
Buraidah Central Hospital