Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease

Zeng Changhao

Status: Withdrawn

Conditions: Dysphagia

Treatments: Behavioral: Rehabilitation therapy; Procedure: Glossopharyngeal Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06215794

2024-KY-0110-001

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

the experimental group

Experimental group

Description:

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.

Treatment:

Procedure: Glossopharyngeal Nerve Block

Behavioral: Rehabilitation therapy

the control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Rehabilitation therapy