Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction

NCT06271395 | Recruiting DMC

• 1 other identifier: Chaoshengqiunang
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cricopharyngeal Achalasia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

The observation group

EXPERIMENTAL

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.

Drug: Injectable Type A Botulinum Toxin

Interventions

Injectable Type A Botulinum Toxin DRUG

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.

Also known as: Botulinum Toxin Injection

The observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Xinzhu Rehabilitation Hospital

Xinzhu, Taiwan

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY CHAIR

Central Study Contacts

Qianyun Lu, Master

CONTACT

15333866454; luqianyun@126.com

Weiji Zhao, Master

CONTACT

17839973473; zwjww2009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: February 28, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)