Gastroesophageal Reflux Disease Clinical Trial
Official title:
A Randomized Controlled Study to Explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease
Verified date | March 2024 |
Source | People's Hospital of Zhengzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 15, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Zheng Da yi Yuan Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Zeng Changhao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastroesophageal Reflux Disease Questionnaire | 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. |
day 1 and day 20 | |
Secondary | Pressure pain threshold | Pressure is applied on the spinous processes of the fourth cervical vertebrae. Pressure will be uniformly increased, and patients are given the identical instruction, "let me know when the sensation of pressure becomes uncomfortable or painful". At this point, the pressure will be immediately released, and the plunger is retracted by the evaluator. And the pressure will be recorded | day 1 and day 20 | |
Secondary | Modified Mayo Clinic Dysphagia-30 questionnaire | Modified Mayo Clinic Dysphagia-30 questionnaire is a standardized tool used to assess the severity and impact of dysphagia on patients' daily lives. The questionnaire consists of 30 items that evaluate several aspects of swallowing function, including swallowing ability, eating habits, and quality of life. The total score for the Modified Mayo Clinic Dysphagia-30 questionnaire is 120 points, and a lower score indicates milder symptoms and less impact on daily life. | day 1 and day 20 |
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