Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas
Withdrawn before enrolling · Phase 2
Conditions studied: Contact Ulcer of Vocal Folds, Granuloma of Vocal Cords, Granuloma, Laryngeal, Granuloma
In brief
Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing, hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but causes significant voice loss, occasional difficulty swallowing and, in our clinical experience, is associated with significant recurrence. The investigators propose injecting another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to maintain the benefit of injection with less loss of voice. The investigators have shown the effectiveness of this treatment in a small, retrospective analysis.
Key facts
- Study ID
- NCT01678053
- Run by
- Phillip Song, MD
- People needed
- 0
- Starts
- 2012-09-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2017-03-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adults age 18 years old and older with vocal fold granulomas
- willing to attend all follow-up appointments
You may not qualify if…
- pregnant females
- woman who are nursing
- minors and other patients unable to give informed consent
- patients taking Plavix
- patients with:
- impaired laryngeal motion as the result of neurological impairment
- vocal fold immobility
- pre-existing oropharyngeal swallowing problems
- history of radiation therapy
- history of aspiration pneumonia
Where it is running
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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