A Randomized Controlled Study to Explore the Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- penetration-aspiration scale
研究概览
简要总结
The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:
• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.
详细描述
Gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus.
The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:
• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for Gastroesophageal Reflux Disease.
- •Age between 18 and 85 years.
- •Confirmed tongue-pharyngeal nerve injury by electromyography.
- •Esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia.
- •Normal higher brain function, able to cooperate with treatment.
排除标准
- •Brain vascular disease diagnosed.
- •Clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders.
- •Concurrent presence of other neurological disorders such as Alzheimer's disease, traumatic brain injury, Parkinson's disease.
- •Esophageal obstruction and severe liver or kidney dysfunction
- •Subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.
研究组 & 干预措施
Rehabilitation therapy+Glossopharyngeal Nerve Block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Based on this, the patients in the experimental group are provided with Stellate Ganglion Block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day.
干预措施: Rehabilitation therapy (Behavioral)
Rehabilitation therapy+Glossopharyngeal Nerve Block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Based on this, the patients in the experimental group are provided with Stellate Ganglion Block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day.
干预措施: Glossopharyngeal Nerve Block (Procedure)
Rehabilitation therapy+Glossopharyngeal Nerve Block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Based on this, the patients in the experimental group are provided with Stellate Ganglion Block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day.
干预措施: Lidocaine Hydrochloride (Drug)
Rehabilitation therapy+placebo injection
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
干预措施: Rehabilitation therapy (Behavioral)
Rehabilitation therapy+placebo injection
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
干预措施: placebo injection (Behavioral)
结局指标
主要结局
penetration-aspiration scale
时间窗: day 1 and day 10
This assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. The scores range between one to eight, with higher levels indicating more severe outcomes of aspiration.
次要结局
- Gastroesophageal Reflux Disease Questionnaire(day 1 and day 10)
- Pressure pain threshold(day 1 and day 10)
研究者
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital