The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
Sponsor study identifier
interventional
30
1 country
1
Study Start
February 28, 2024
Actual (reported)Primary Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2024
Actual (reported)February 21, 2024
Actual (reported)February 28, 2024
Actual (reported)October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
functional oral intake scale
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
Penetration-Aspiration Scale
day 1, day 15, day 29, day 169
The Fiberoptic Endoscopic Dysphagia Severity Scale
day 1, day 15, day 29, day 169
Murray secretion scale
day 1, day 15, day 29, day 169
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.
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Xinzhu Rehabilitation Hospital
Xinzhu, Taiwan
Nieto Luis, Master
Site Coordinator of United Medical Group
First Submitted
February 14, 2024
First Posted
February 21, 2024
Study Start
February 28, 2024
Actual (reported)Primary Completion
October 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 7, 2024
Record last verified: 2024-03
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