Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction

Last updated: March 5, 2024
Sponsor: Zeng Changhao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Achalasia

Treatment

Injectable Type A Botulinum Toxin

Clinical Study ID

NCT06271395
Chaoshengqiunang
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Videofluoroscopic swallowing study (VFSS) confirming incomplete/opening dysfunction ofthe cricopharyngeal muscle;
  • No significant improvement in swallowing function after standardized rehabilitationtreatment for more than 2 weeks (unchanged or decreased FOIS);
  • Presence of swallowing initiation, with VFSS showing that the upward movement of thehyoid bone during swallowing is greater than half the height of the C3 vertebral body;
  • Stable vital signs, alert consciousness, and cooperation with treatment;

Exclusion

Exclusion Criteria:

  • Patients with severe cognitive impairments, psychiatric disorders, and severecardiopulmonary 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 coagulationdisorders.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Injectable Type A Botulinum Toxin
Phase:
Study Start date:
February 28, 2024
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • The Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Xinzhu Rehabilitation Hospital

    Xinzhu,
    Taiwan

    Active - Recruiting

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