Ultrasound-guided botulinum toxin injection for cricopharyngeal muscle dysfunction
The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
This study is testing if using ultrasound to guide botulinum toxin injections can help people with swallowing problems caused by cricopharyngeal muscle dysfunction feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xinzhu) |
| Trial ID | NCT06271395 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of ultrasound-guided botulinum toxin injections combined with balloon localization to treat cricopharyngeal muscle dysfunction, specifically cricopharyngeal achalasia. The approach allows for real-time visualization during the injection process, enhancing precision and minimizing complications associated with traditional methods. Patients with confirmed swallowing dysfunction who have not improved with standard rehabilitation will be treated and monitored for clinical outcomes. The goal is to alleviate muscle spasms and improve swallowing function.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed cricopharyngeal muscle dysfunction who have not responded to previous rehabilitation efforts.
Not a fit: Patients with severe cognitive impairments, psychiatric disorders, or significant structural abnormalities in the pharynx and larynx may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function and quality of life for patients suffering from cricopharyngeal muscle dysfunction.
How similar studies have performed: While botulinum toxin has been used in similar contexts, the specific combination of ultrasound guidance and balloon localization is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xinzhu
- Xinzhu Rehabilitation Hospital — Xinzhu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Qianyun Lu, Master
- Email: luqianyun@126.com
- Phone: 15333866454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.