Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease

March 2, 2024 updated by: Zeng Changhao

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Zheng Da yi Yuan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the experimental group
The study lasts 20d 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.
Behavioral: Rehabilitation therapy

Rehabilitation therapy includes

  1. Diet management: Avoiding consumption of irritant foods and beverages, such as spicy foods, caffeine, alcohol, and acidic foods. Controlling portion sizes and meal timing, and adopting smaller, more frequent meals.
  2. Lifestyle adjustments: Avoiding lying down or bending immediately after meals, maintaining a sitting or upright position for at least 2 hours. Adjusting sleeping positions by elevating the head of the bed to reduce nighttime acid reflux. Avoiding excessive exertion and managing stress levels.
  3. Rehabilitation training: Strengthening the control of esophageal and gastric muscles through rehabilitation exercises to improve the function of the gastroesophageal sphincter and prevent gastric fluid reflux.
Procedure: Stellate ganglion block
Based on the invention above, the patients in the observation group were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Active Comparator: the control group
The study lasts 20d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
Behavioral: Rehabilitation therapy

Rehabilitation therapy includes

  1. Diet management: Avoiding consumption of irritant foods and beverages, such as spicy foods, caffeine, alcohol, and acidic foods. Controlling portion sizes and meal timing, and adopting smaller, more frequent meals.
  2. Lifestyle adjustments: Avoiding lying down or bending immediately after meals, maintaining a sitting or upright position for at least 2 hours. Adjusting sleeping positions by elevating the head of the bed to reduce nighttime acid reflux. Avoiding excessive exertion and managing stress levels.
  3. Rehabilitation training: Strengthening the control of esophageal and gastric muscles through rehabilitation exercises to improve the function of the gastroesophageal sphincter and prevent gastric fluid reflux.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1 and day 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: day 1 and day 20
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
Modified Mayo Clinic Dysphagia-30 questionnaire
Time Frame: day 1 and day 20
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeng Changhao

Collaborators

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Study Director: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-0110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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