Clinical trial
A Randomized Controlled Study to Explore the Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease
Name
Glossopharyngeal Nerve Block
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
Rehabilitation therapy
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.
Arms:
Rehabilitation therapy+Glossopharyngeal Nerve Block, Rehabilitation therapy+placebo injection
Glossopharyngeal Nerve Block
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 \[20 g/L lidocaine injection\].
Arms:
Rehabilitation therapy+Glossopharyngeal Nerve Block
Lidocaine Hydrochloride
When no blood or cerebrospinal fluid is aspirated, the blocking drug can be injected \[20 g/L lidocaine injection\]. once a day. 1 ml per time.
Arms:
Rehabilitation therapy+Glossopharyngeal Nerve Block
placebo injection
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. 1 milliliter of normal saline will be used for injection.
Arms:
Rehabilitation therapy+placebo injection
Size
80
Primary endpoint
penetration-aspiration scale
day 1 and day 10
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-03-25
1 organization
1 product
1 indication
Organization
Copka SonpashanProduct
LidocaineIndication
Difficulty swallowing