DysphagiaNCT06328205
Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease
A study testing Rehabilitation therapy, Glossopharyngeal Nerve Block and Lidocaine Hydrochloride in people with Dysphagia, run by Copka Sonpashan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Rehabilitation therapy, Glossopharyngeal Nerve Block and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Randomized Controlled Study to Explore the Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease
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.
- Conditions
- Dysphagia
- Being tested
- Rehabilitation therapy, Glossopharyngeal Nerve Block, Lidocaine Hydrochloride, placebo injection
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation therapyBehavioural
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.
Glossopharyngeal Nerve BlockProcedure or surgery
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].
Lidocaine HydrochlorideDrug
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.
placebo injectionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation therapy+Glossopharyngeal Nerve Block | Experimental | 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. Receives: Behavioral: Rehabilitation therapy; Procedure: Glossopharyngeal Nerve Block; Drug: Lidocaine Hydrochloride |
| Rehabilitation therapy+placebo injection | Placebo comparator | The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Receives: Behavioral: Rehabilitation therapy; Behavioral: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The scores range between one to eight, with higher levels indicating more severe outcomes of aspiration.
Measured: day 1 and day 10
Secondary outcomes (2)
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. 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.
Measured: day 1 and day 10
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
Measured: day 1 and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copka Sonpashan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328205
- Sponsor's protocol ID
- Glossopharyngeal Nerve Block
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Explore the Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT06328205
- Acronym / sponsor ID
- Glossopharyngeal Nerve Block
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copka SonpashanOther government
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation therapy+Glossopharyngeal Nerve Block | Experimental | Behavioral: Rehabilitation therapy, Procedure: Glossopharyngeal Nerve Block, Drug: Lidocaine HydrochlorideThe 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 | Placebo comparator | Behavioral: Rehabilitation therapy, Behavioral: placebo injectionThe study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation therapyRehabilitation 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. | Behavioural | Rehabilitation therapy+Glossopharyngeal Nerve Block, Rehabilitation therapy+placebo injection |
| Glossopharyngeal Nerve BlockThe 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]. | Procedure or surgery | Rehabilitation therapy+Glossopharyngeal Nerve Block |
| Lidocaine HydrochlorideWhen 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. | Drug | Rehabilitation therapy+Glossopharyngeal Nerve Block |
| placebo injectionThe 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. | Behavioural | Rehabilitation therapy+placebo injection |
Primary outcome
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.
2 secondary outcomes
Gastroesophageal Reflux Disease Questionnaire
Time frame: day 1 and day 10
Pressure pain threshold
Time frame: day 1 and day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation therapy, Glossopharyngeal Nerve Block and Lidocaine Hydrochloride in people with Dysphagia, run by Copka Sonpashan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
penetration-aspiration scale (time frame: day 1 and day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.