Clinical trial NCT06271395: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction
Official title: The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cricopharyngeal Achalasia
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: functional oral intake scale
timeFrame: day 1, day 15, day 29, day 169
Secondary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1, day 15, day 29, day 169
measure: The Fiberoptic Endoscopic Dysphagia Severity Scale
timeFrame: day 1, day 15, day 29, day 169
measure: Murray secretion scale
timeFrame: day 1, day 15, day 29, day 169
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Xinzhu Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References: