Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Functional Oral Intake Scale
研究概览
简要总结
This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.
详细描述
Dysphagia is a frequent and potentially serious complication of stroke. This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.
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
- •Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- •Dysphagia.
- •Age >18 years.
- •First-time stroke.
- •Steady vital signs,
- •Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.
排除标准
- •Allergy to Lidocaine injection or vitamin B12 injection;
- •Severe cognitive impairment;
- •Coagulation disorders;
- •Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
- •Complicated with other neurological diseases;
- •Dysphagia caused by other diseases or reasons.
研究组 & 干预措施
Stellate Nerve Block+ routine rehabilitation treatment
The patients were given Nerve block and routine rehabilitation treatment for 10 days.
干预措施: Injection (Procedure)
Stellate Nerve Block+ routine rehabilitation treatment
The patients were given Nerve block and routine rehabilitation treatment for 10 days.
干预措施: Lidocaine Hydrochloride (Drug)
Stellate Nerve Block+ routine rehabilitation treatment
The patients were given Nerve block and routine rehabilitation treatment for 10 days.
干预措施: Comprehensive therapy (Behavioral)
placebo+routine rehabilitation treatment
The patients were given placebo block and routine rehabilitation treatment for 10 days.
干预措施: Comprehensive therapy (Behavioral)
placebo+routine rehabilitation treatment
The patients were given placebo block and routine rehabilitation treatment for 10 days.
干预措施: placebo (Behavioral)
结局指标
主要结局
Functional Oral Intake Scale
时间窗: day 1 and day 10
The Functional Oral Intake Scale (FOIS) is a tool used to assess the level of independence in oral intake for individuals with swallowing difficulties. The scale ranges from Level 1 to Level 7, with higher Levels indicating better swallowing function.
次要结局
- Yale Pharyngeal Residue Severity Rating Scale(day 1 and day 10)
- penetration-aspiration scale(day 1 and day 10)
- The Swallowing Quality of Life Questionnaire(day 1 and day 10)
研究者
Copka Sonpashan
Director
Chao Phya Abhaibhubejhr Hospital