The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Taiwan
Xinzhu Rehabilitation Hospital
RECRUITING
Xinzhu
Contact Information
Primary
Qianyun Lu, Master
luqianyun@126.com
15333866454
Backup
Weiji Zhao, Master
zwjww2009@163.com
17839973473
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2024-10
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Zeng Changhao

This content was sourced from clinicaltrials.gov