Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction

Copka Sonpashan

Status: Not yet enrolling

Conditions: Cricopharyngeal Achalasia

Treatments: Procedure: Injection; Drug: botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT06328556

Ultrasound-guided Botulinum

Details and patient eligibility

About

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, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Full description

The patient's long-term inadequate food intake leads to malnutrition, decreased quality of life, and impacts the prognosis of the disease. Currently, both domestically and internationally, treatment options for cricopharyngeal muscle dysfunction include balloon dilation technique, surgical incision, and botulinum toxin injection. Passive dilation with a balloon can easily cause mucosal edema and damage. Cricopharyngeal myotomy surgery often presents complications such as local infection, excessive bleeding, and local nerve damage. Botulinum toxin can alleviate muscle spasms and has been widely used in the treatment of hypertonic disorders [3]. Common injection localization methods include ultrasound, electromyography, and endoscopy. 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. Combining it with balloon fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Injectable Type A Botulinum Toxin

Experimental group

Description:

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.

Treatment:

Procedure: Injection

Drug: botulinum toxin type A