A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia: A Randomized Controlled Study
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
- The Functional Oral Intake Scale
研究概览
简要总结
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. 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 Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
详细描述
Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. 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 Rosenbek 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.
- •Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
- •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
placebo
The patients were given placebo block and routine therapy for 10 days.
干预措施: placebo block (Procedure)
Nerve block
The patients were given Nerve block and routine therapy for 10 days.
干预措施: Nerve Block (Procedure)
Nerve block
The patients were given Nerve block and routine therapy for 10 days.
干预措施: Lidocaine Hydrochloride (Drug)
Nerve block
The patients were given Nerve block and routine therapy for 10 days.
干预措施: routine therapy (Behavioral)
placebo
The patients were given placebo block and routine therapy for 10 days.
干预措施: routine therapy (Behavioral)
结局指标
主要结局
The 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
- Video fluoroscopic swallowing study(day 1 and day 10)
- Yale Pharyngeal Residue Severity Rating Scale(day 1 and day 10)
- The Swallowing Quality of Life Questionnaire(day 1 and day 10)
- penetration-aspiration scale(day 1 and day 10)
研究者
Babujinaya Cela
Director
Buraidah Central Hospital