Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease

NCT06304870 | Not Yet Recruiting

• 1 other identifier: SYB-reflux
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is: • Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms 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 Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Rosenbek penetration-aspiration scale

  This assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration.

  day 1 and day 20

Secondary Outcomes (2)

• Gastroesophageal Reflux Disease Questionnaire

  day 1 and day 20

• Pressure pain threshold

  day 1 and day 20

Study Arms (2)

Rehabilitation therapy+Placebo Glossopharyngeal Nerve Block

PLACEBO COMPARATOR

The study lasts 20d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy and placebo nerve block.

Behavioral: Rehabilitation therapy; Procedure: Injection

Rehabilitation therapy+Glossopharyngeal Nerve Block

EXPERIMENTAL

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; Drug: Lidocaine; Procedure: Injection

Interventions

Rehabilitation therapy BEHAVIORAL

Rehabilitation therapy includes 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. 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. 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.

Rehabilitation therapy+Glossopharyngeal Nerve Block; Rehabilitation therapy+Placebo Glossopharyngeal Nerve Block

Lidocaine DRUG

The patient lies supine without a pillow, turns the head to the contralateral side of the block, and at the midpoint of the line connecting the angle of the mandible with the mastoid process (the styloid process), the skin is disinfected, and a 22-gauge, 3.8 cm puncture needle is loaded onto a 5 mL syringe. The puncture needle is inserted perpendicularly to the skin surface at the styloid process, and advanced through the skin and subcutaneous tissue until it contacts the bone of the styloid process. The puncture needle is then retracted and advanced anteriorly beyond the styloid process by 0.5-1.0 cm. When no blood or cerebrospinal fluid is aspirated, the blocking drug can be injected \[20 g/L lidocaine injection\].

Rehabilitation therapy+Glossopharyngeal Nerve Block

Injection PROCEDURE

The patient lies supine without a pillow, turns the head to the contralateral side of the block, and at the midpoint of the line connecting the angle of the mandible with the mastoid process (the styloid process), the skin is disinfected, and a 22-gauge, 3.8 cm puncture needle is loaded onto a 5 mL syringe. The puncture needle is inserted perpendicularly to the skin surface at the styloid process, and advanced through the skin and subcutaneous tissue until it contacts the bone of the styloid process.

Rehabilitation therapy+Glossopharyngeal Nerve Block; Rehabilitation therapy+Placebo Glossopharyngeal Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the diagnostic criteria for Gastroesophageal Reflux Disease.
• Age between 18 and 65 years.
• Confirmed tongue-pharyngeal nerve injury by electromyography.
• Esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia.
• Normal higher brain function, able to cooperate with treatment.

You may not qualify if:

• Brain vascular disease diagnosed.
• Clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders.
• Concurrent presence of other neurological disorders such as Alzheimer's disease, traumatic brain injury, Parkinson's disease.
• Esophageal obstruction and severe liver or kidney dysfunction
• Subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.

Sponsors & Collaborators

• Muhammad: lead

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Rehabilitation; Lidocaine; Injections

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lavie Ce, Master

CONTACT

15333828388; zenghongjixx@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share