- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271395
Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction
The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weiji Zhao, Master
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Contact Backup
- Name: Qianyun Lu, Master
- Phone Number: 15333866454
- Email: luqianyun@126.com
Study Locations
-
-
-
Xinzhu, Taiwan
- Recruiting
- Xinzhu Rehabilitation Hospital
-
Contact:
- Haim Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Videofluoroscopic swallowing study (VFSS) confirming incomplete/opening dysfunction of the cricopharyngeal muscle;
- No significant improvement in swallowing function after standardized rehabilitation treatment for more than 2 weeks (unchanged or decreased FOIS);
- Presence of swallowing initiation, with VFSS showing that the upward movement of the hyoid bone during swallowing is greater than half the height of the C3 vertebral body;
- Stable vital signs, alert consciousness, and cooperation with treatment;
Exclusion Criteria:
- Patients with severe cognitive impairments, psychiatric disorders, and severe cardiopulmonary diseases;
- Abnormalities in the pharynx and larynx structures;
- Patients with malignant tumors;
- Patients with infections or wounds at the injection site;
- Patients allergic to botulinum toxin; Patients with bleeding tendencies or coagulation disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The observation group
This group will be given Left cricopharyngeal muscle botulinum toxin injection, Injectable Type A Botulinum Toxin (National Medical Products Administration Approval Number S10970037) 100 unit, diluted with 1ml of 0.9% sodium chloride solution for injection and kept ready for use.
Only once.
|
Injectable Type A Botulinum Toxin (National Medical Products Administration Approval Number S10970037) 100 unit, diluted with 1ml of 0.9% sodium chloride solution for injection and kept ready for use.
Only once.
Using an ultrasound probe to scan the neck, the position of the lowest point, highest point, and lower middle point of the esophageal high-pressure zone are determined, and marks are made on the body surface and catheter wall.
The high-pressure point and the lower middle point are selected as injection sites on the left side.
The above area is locally disinfected, and the probe is covered with a sterile cover and coated with sterile coupling agent.
Using a plane approach, 0.3ml or 30 unit of botulinum toxin is injected separately after reaching the esophageal circular layer at each of the two left injection points.
A total of 60 unit of botulinum toxin is injected at the two left points.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional oral intake scale
Time Frame: day 1, day 15, day 29, day 169
|
The Functional Oral Intake Scale (FOIS) is a tool used to assess the functional oral intake of individuals with dysphagia.
The scale ranges from Level 1 to Level 7, with Level 1 indicating nothing by mouth and Level 7 representing total oral diet with no restrictions.
In this scale, a higher score indicates better functional oral intake capabilities, meaning that higher levels correspond to better oral intake abilities.
|
day 1, day 15, day 29, day 169
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penetration-Aspiration Scale
Time Frame: day 1, day 15, day 29, day 169
|
The Penetration-Aspiration Scale (PAS) is a tool used to evaluate the severity of penetration and aspiration events that occur during swallowing. It assesses the extent to which food or liquid enters the airway during swallowing, indicating potential risks to respiratory health. The PAS ranges from Level 1 to Level 8, with Level 1 representing no penetration or aspiration and Level 8 representing material entering the airway with no effort to eject it. In this scale, a lower score indicates better swallowing function, as lower levels indicate less penetration or aspiration occurring during the swallowing process. It is important to minimize penetration and aspiration events to reduce the risk of respiratory complications and maintain optimal swallowing function. |
day 1, day 15, day 29, day 169
|
The Fiberoptic Endoscopic Dysphagia Severity Scale
Time Frame: day 1, day 15, day 29, day 169
|
The Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is an instrumental assessment used to evaluate swallowing function. The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) is a tool used to rate the severity of dysphagia based on findings from FEES. The FEDSS ranges from Level 1 to Level 8, with Level 1 indicating normal swallowing physiology and Level 8 representing severe dysphagia with no protective laryngeal elevation. In this scale, a higher score indicates worse swallowing function, as higher levels indicate more severe dysphagia symptoms. The FEDSS is used to evaluate various aspects of swallowing function, including the efficiency of swallowing, the coordination between breathing and swallowing, and the presence of pharyngeal residue after swallowing. By identifying the severity of dysphagia using the FEDSS, clinicians can develop appropriate treatment plans to improve swallowing function and reduce the risk of complications. |
day 1, day 15, day 29, day 169
|
Murray secretion scale
Time Frame: day 1, day 15, day 29, day 169
|
The Murray secretion scale is a commonly used tool to assess the amount and characteristics of respiratory secretions in patients with respiratory diseases or conditions. It consists of a scoring system ranging from 0 to 4, with 0 indicating no secretions and 4 indicating thick, copious, and tenacious secretions that cannot be cleared. The scale assesses the color, amount, and viscosity of respiratory secretions, as well as the ease with which they can be cleared. The scale can be useful in monitoring the effectiveness of treatments aimed at reducing sputum production and improving airway clearance. |
day 1, day 15, day 29, day 169
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophageal Achalasia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Botulinum Toxins
Other Study ID Numbers
- Chaoshengqiunang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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