- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347250
A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia
A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Zhenzhou, China
- ZhenD No.1 Hos.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
- Age >18 years.
- First-time stroke.
- Steady vital signs,
- Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.
Exclusion Criteria:
- Allergy to Lidocaine injection or vitamin B12 injection;
- Severe cognitive impairment;
- Coagulation disorders;
- Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
- Complicated with other neurological diseases;
- Dysphagia caused by other diseases or reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nerve block
The patients were given Nerve block and routine therapy for 10 days.
|
The percutaneous approach via the paratracheal route was used for Stellate ganglion block.
The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck.
Then, routine disinfection of the neck skin was performed.
The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
the patients were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).
All the participants are provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.). Regrading swallowing function training, both groups are given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic/isometric swallowing exercises, supraglottic swallowing exercises, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day. |
Placebo Comparator: placebo
The patients were given placebo block and routine therapy for 10 days.
|
All the participants are provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.). Regrading swallowing function training, both groups are given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic/isometric swallowing exercises, supraglottic swallowing exercises, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.
the patients were provided with normal saline.
The percutaneous approach via the paratracheal route was used for Stellate ganglion block.
The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck.
Then, routine disinfection of the neck skin was performed.
The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Functional Oral Intake Scale
Time Frame: day 1 and day 10
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The Functional Oral Intake Scale (FOIS) is a tool used to assess the level of independence in oral intake for individuals with swallowing difficulties.
The scale ranges from Level 1 to Level 7, with higher Levels indicating better swallowing function.
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day 1 and day 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Video fluoroscopic swallowing study
Time Frame: day 1 and day 10
|
The patient was required to take a sitting position with the head naturally upright.
Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms).
If the patient exhibited aspiration, the test would stop.
If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety.
Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase.
The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase.
The total score was calculated as the final result.
The final score was positively correlated with the swallowing function.
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day 1 and day 10
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Yale Pharyngeal Residue Severity Rating Scale
Time Frame: day 1 and day 10
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The Yale Pharyngeal Residue Severity Rating Scale (Yale) was used to assess the severity of pharyngeal residue in patients.
While PAS primarily evaluated whether food or liquid entered the airway, Yale focused on the condition of pharyngeal residue.
The scale includes the four levels from 0 to 3, with lower levels indicating less severe pharyngeal residue.
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day 1 and day 10
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penetration-aspiration scale
Time Frame: day 1 and day 10
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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.
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day 1 and day 10
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The Swallowing Quality of Life Questionnaire
Time Frame: day 1 and day 10
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The Swallowing Quality of Life Questionnaire (SWAL-QOL) is a tool designed to assess how swallowing difficulties impact an individual's quality of life. The questionnaire covers various aspects such as eating, speech, and social interaction to understand the challenges and effects of swallowing disorders on daily life. SWAL-QOL scores can range from 0 to 100, with higher scores indicating a better quality of life related to swallowing function. Therefore, a higher SWAL-QOL score reflects less negative impact of swallowing difficulties on an individual's overall quality of life, highlighting better adaptation to and management of swallowing issues. |
day 1 and day 10
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nieto Luis, Master, Site Coordinator of United Medical Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Motor Neuron Disease
- Bulbar Palsy, Progressive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- SGB-Bulbar Palsy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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