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Not yet recruitingNCT06304870Updated Mar 15, 2024

Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease

An interventional study of Rehabilitation therapy and Lidocaine in Dysphagia, sponsored by Muhammad. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Muhammad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Dysphagia
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Rehabilitation therapy+Placebo Glossopharyngeal Nerve Block

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

    Behavioral: Rehabilitation therapy · Procedure: Injection

  • Experimental
    Rehabilitation therapy+Glossopharyngeal Nerve Block

    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.

    Behavioral: Rehabilitation therapy · Drug: Lidocaine · Procedure: Injection

Interventions

  • BehavioralRehabilitation 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.

  • DrugLidocaine

    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 \[20 g/L lidocaine injection\].

  • ProcedureInjection

    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.

05

What researchers measure

Primary outcomes

  1. Rosenbek penetration-aspiration scale

    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. There were 8 levels in the results, with higher levels indicating more severe aspiration.

    Time frame: day 1 and day 20

Secondary outcomes

  1. Gastroesophageal Reflux Disease Questionnaire

    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. The maximum score for the Test is 12 points, with a lower score indicating milder symptoms and a higher score indicating more severe symptoms.

    Time frame: day 1 and day 20

  2. Pressure pain threshold

    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

    Time frame: day 1 and day 20

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06304870
Lead sponsor
Muhammad
Responsible party
Muhammad (Research Director, Ahmadu Bello University Teaching Hospital) — Sponsor-investigator
First posted
Mar 12, 2024
Start date
Mar 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Lavie Ce, Master
Contact
zenghongjixx@qq.com
15333828388
Nieto Luis, Master
principal investigator · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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