A Randomized Controlled Study to Explore the Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Dysphagia
- Sponsor
- Copka Sonpashan
- Enrollment
- 80
- Primary Endpoint
- penetration-aspiration scale
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
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 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.
Investigators
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital
Eligibility Criteria
Inclusion Criteria
- •Meeting the diagnostic criteria for Gastroesophageal Reflux Disease.
- •Age between 18 and 85 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.
Arms & Interventions
Rehabilitation therapy+Glossopharyngeal Nerve Block
The study lasts 10d 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.
Intervention: Rehabilitation therapy
Rehabilitation therapy+Glossopharyngeal Nerve Block
The study lasts 10d 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.
Intervention: Glossopharyngeal Nerve Block
Rehabilitation therapy+Glossopharyngeal Nerve Block
The study lasts 10d 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.
Intervention: Lidocaine Hydrochloride
Rehabilitation therapy+placebo injection
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
Intervention: Rehabilitation therapy
Rehabilitation therapy+placebo injection
The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.
Intervention: placebo injection
Outcomes
Primary Outcomes
penetration-aspiration scale
Time Frame: day 1 and day 10
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. The scores range between one to eight, with higher levels indicating more severe outcomes of aspiration.
Secondary Outcomes
- Gastroesophageal Reflux Disease Questionnaire(day 1 and day 10)
- Pressure pain threshold(day 1 and day 10)