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Clinical Trials/NCT06215742
NCT06215742
Withdrawn
Not Applicable

A Randomized Controlled Study to Explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease

Zeng Changhao1 site in 1 countryJanuary 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastroesophageal Reflux Disease
Sponsor
Zeng Changhao
Locations
1
Primary Endpoint
Gastroesophageal Reflux Disease Questionnaire
Status
Withdrawn
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.

Registry
clinicaltrials.gov
Start Date
January 30, 2024
End Date
May 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

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.

Outcomes

Primary Outcomes

Gastroesophageal Reflux Disease Questionnaire

Time Frame: day 1 and day 20

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

  • Pressure pain threshold(day 1 and day 20)
  • Modified Mayo Clinic Dysphagia-30 questionnaire(day 1 and day 20)

Study Sites (1)

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