Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease
- Conditions
- Dysphagia
- Interventions
- Behavioral: Rehabilitation therapyBehavioral: placebo injectionProcedure: Glossopharyngeal Nerve Block
- Registration Number
- NCT06328205
- Lead Sponsor
- Copka Sonpashan
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rehabilitation therapy+placebo injection placebo injection The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Rehabilitation therapy+Glossopharyngeal Nerve Block Rehabilitation therapy 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. Rehabilitation therapy+Glossopharyngeal Nerve Block 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. Rehabilitation therapy+placebo injection Rehabilitation therapy The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Rehabilitation therapy+Glossopharyngeal Nerve Block Lidocaine Hydrochloride 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.
- Primary Outcome Measures
Name Time Method penetration-aspiration scale 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 Outcome Measures
Name Time Method Pressure pain threshold day 1 and day 10 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
Gastroesophageal Reflux Disease Questionnaire day 1 and day 10 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.