Clinical trial NCT06304870: Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease
Official title: Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease: A Randomized Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rosenbek penetration-aspiration scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Gastroesophageal Reflux Disease Questionnaire
timeFrame: day 1 and day 20
measure: Pressure pain threshold
timeFrame: day 1 and day 20
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: