A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Video fluoroscopic swallowing study
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 (n=33) or the control group (n=33). 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, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), 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 (n=33) or the control group (n=33). 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, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 80 years;
- •New-onset stroke, confirmed by head CT or MRI;
- •The course of disease between 1 to 6 months;
- •With pharyngeal dysphagia shown by VFSS;
- •Stable vital signs;
- •Voluntary participation in the study.
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;
- •With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);
- •Dysphagia caused by other diseases or reasons.
研究组 & 干预措施
The observation group
Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.
干预措施: comprehensive rehabilitation (Behavioral)
The observation group
Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.
干预措施: SGB (Drug)
The control group
Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.
干预措施: comprehensive rehabilitation (Behavioral)
结局指标
主要结局
Video fluoroscopic swallowing study
时间窗: day 1 and day 20
The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function.
次要结局
- Rosenbek penetration-aspiration scale(day 1 and day 20)
- Kubota water swallowing test(day 1 and day 20)
研究者
Zeng Changhao
PI
People's Hospital of Zhengzhou University