A Randomized Controlled Study to Explore Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Copka Sonpashan
- Enrollment
- 80
- Primary Endpoint
- Gastroesophageal Reflux Disease Questionnaire
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •contraindications for stellate ganglion block.
- •peptic ulcer.
- •previous or present gastric cancer.
- •previous gastric surgery.
- •recent fractures or cervical trauma.
Arms & Interventions
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.
Intervention: Rehabilitation therapy
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.
Intervention: Stellate ganglion block
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.
Intervention: Lidocaine hydrochloride
Rehabilitation therapy+placebo block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
Intervention: Rehabilitation therapy
Rehabilitation therapy+placebo block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
Intervention: Placebo injection
Outcomes
Primary Outcomes
Gastroesophageal Reflux Disease Questionnaire
Time Frame: 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.
Secondary Outcomes
- Modified Mayo Clinic Dysphagia-30 questionnaire(day 1 and day 10)
- Pressure pain threshold(day 1 and day 10)