A Randomized Controlled Study to Explore Effect of Stellate Ganglion Block on 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
- Gastroesophageal Reflux Disease Questionnaire
研究概览
简要总结
The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:
• Can stellate ganglion block improve gastroesophageal reflux symptoms better 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 Stellate Ganglion Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion 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 Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:
• Can stellate ganglion block improve gastroesophageal reflux symptoms better 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 Stellate Ganglion Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroesophageal Reflux Disease diagnosis after determination of acid reflux by gastroenterologist, with upper endoscopy and/or impedance-pHmetry, which confirmed esophagitis and/or hiatal hernia.
- •aged between 18 and 80 years old.
- •subjects who tolerate cervical movements in sitting position.
- •stable vital signs.
- •normal consciousness
排除标准
- •contraindications for stellate ganglion block.
- •peptic ulcer.
- •previous or present gastric cancer.
- •previous gastric surgery.
- •recent fractures or cervical trauma.
研究组 & 干预措施
Rehabilitation therapy+Stellate ganglion 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+Stellate ganglion 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: Stellate ganglion block (Procedure)
Rehabilitation therapy+Stellate ganglion 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 block
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 block
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 (Procedure)
结局指标
主要结局
Gastroesophageal Reflux Disease Questionnaire
时间窗: day 1 and day 10
The Gastroesophageal Reflux Disease Questionnaire is a commonly used questionnaire for assessing the symptoms and severity of gastroesophageal reflux disease. It was developed by gastrointestinal experts in Germany and consists of six questions that evaluate the frequency and severity of gastroesophageal reflux disease symptoms. For each question, patients are required to select the answer that best corresponds to their situation. Different scores are assigned based on the chosen answers, and a total score is calculated at the end. The maximum score for the Test is 12 points, with a lower score indicating milder symptoms and a higher score indicating more severe symptoms.
次要结局
- Modified Mayo Clinic Dysphagia-30 questionnaire(day 1 and day 10)
- Pressure pain threshold(day 1 and day 10)
研究者
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital