Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas

• Status: Withdrawn
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary; Phillip Song, MD
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; Omeprazole; onabotulinumtoxinA; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• adults age 18 years old and older with vocal fold granulomas

• willing to attend all follow-up appointments

Exclusion Criteria:

• 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