Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2016 |
| Start Date: | September 2012 |
| End Date: | January 2015 |
A Randomized Controlled Trial Comparing Proton Pump Inhibitor Therapy With and Without Interarytenoid Botulinum Toxin Injection for Vocal Fold Granuloma
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.
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.
Vocal fold granulomas may be due to reflux, voice trauma, intubation, multiple or unknown
etiologies. Regimens of voice therapy and anti-reflux medications have show resolution rates
varying from 38% to 100%, with recurrence rates of 15-20%, and up to 50-92% in
surgical-operated on recalcitrant granulomas. Nasri and colleagues first proposed
thyroarytenoid botulinum toxin type A (BOTOX) injections for vocal fold granulomas with
success. They posited that the chemically paralyzed muscle would result in limited contact
at the site of the granuloma, allowing for healing. Damrose and Damrose further showed that
thyroarytenoid BOTOX injections were effective in treating recalcitrant vocal fold
granulomas. Both of the above groups noted hoarseness as an expected side effect. Pham and
colleagues showed complete resolution of granulomas in 2-8 weeks after treatment with
thyroarytenoid BOTOX injections. This was compared to mean granuloma resolution of 5.7
months proton pump inhibitor therapy alone. The investigators reviewed eight patients
treated for recalcitrant vocal fold granuloma at Mass Eye and Ear with interarytenoid BOTOX
injections and found no serious adverse effects and complete response in seven cases. The
investigators now seek to compare interarytenoid BOTOX injections to standard anti-reflux
therapy alone to see if the addition of IA Botox injections improves response rates at 3
months. The investigators chose this timeframe since 86% of granulomas treated in our
retrospective study had resolved 3 months after initiation of treatment compared to 25% of
granulomas treated with medical management.
The investigators will not include a Thyroarytenoid injection arm in this study as this
technique has not been useful in our clinical experience.
For those who consent, a Voice Handicap Index survey (6 - see attached) will be completed.
Participants will then be randomized to undergo only medical therapy with omeprazole (40mg
by mouth twice daily ) or an interarytenoid BOTOX injection followed by the same reflux
regimen. Randomization will be performed by the Tufts online randomization plan, which may
be found at: http://www.tufts.edu/~gdallal/PLANDOC.HTM. This program generates a random
order in which participants will be enrolled in either of the two arms of the study.
The injection will consist of 10 units of botulinum toxin injected into the interarytenoid
muscle under fiberoptic visualization. All participants will remain on the PPI therapy for
the duration of the study. Participants will receive prescriptions for PPI medication from
the attending Laryngologist and participants will then be responsible for acquiring and
taking their medications.
Injections will be performed per standard MEEI Laryngology protocol for interarytenoid BOTOX
injection. Participants will then be evaluated at 1.5 months, 3 months and 6 months with
fiberoptic examination as well as Voice Handicap Index & Reflux Symptom Index. Participants
in the medication only arm who continue to have a granuloma at 3 months will receive a BOTOX
injection. They will be re-evaluated 3 months after the injection. Examinations will be
recorded and reviewed by blinded reviewers.
etiologies. Regimens of voice therapy and anti-reflux medications have show resolution rates
varying from 38% to 100%, with recurrence rates of 15-20%, and up to 50-92% in
surgical-operated on recalcitrant granulomas. Nasri and colleagues first proposed
thyroarytenoid botulinum toxin type A (BOTOX) injections for vocal fold granulomas with
success. They posited that the chemically paralyzed muscle would result in limited contact
at the site of the granuloma, allowing for healing. Damrose and Damrose further showed that
thyroarytenoid BOTOX injections were effective in treating recalcitrant vocal fold
granulomas. Both of the above groups noted hoarseness as an expected side effect. Pham and
colleagues showed complete resolution of granulomas in 2-8 weeks after treatment with
thyroarytenoid BOTOX injections. This was compared to mean granuloma resolution of 5.7
months proton pump inhibitor therapy alone. The investigators reviewed eight patients
treated for recalcitrant vocal fold granuloma at Mass Eye and Ear with interarytenoid BOTOX
injections and found no serious adverse effects and complete response in seven cases. The
investigators now seek to compare interarytenoid BOTOX injections to standard anti-reflux
therapy alone to see if the addition of IA Botox injections improves response rates at 3
months. The investigators chose this timeframe since 86% of granulomas treated in our
retrospective study had resolved 3 months after initiation of treatment compared to 25% of
granulomas treated with medical management.
The investigators will not include a Thyroarytenoid injection arm in this study as this
technique has not been useful in our clinical experience.
For those who consent, a Voice Handicap Index survey (6 - see attached) will be completed.
Participants will then be randomized to undergo only medical therapy with omeprazole (40mg
by mouth twice daily ) or an interarytenoid BOTOX injection followed by the same reflux
regimen. Randomization will be performed by the Tufts online randomization plan, which may
be found at: http://www.tufts.edu/~gdallal/PLANDOC.HTM. This program generates a random
order in which participants will be enrolled in either of the two arms of the study.
The injection will consist of 10 units of botulinum toxin injected into the interarytenoid
muscle under fiberoptic visualization. All participants will remain on the PPI therapy for
the duration of the study. Participants will receive prescriptions for PPI medication from
the attending Laryngologist and participants will then be responsible for acquiring and
taking their medications.
Injections will be performed per standard MEEI Laryngology protocol for interarytenoid BOTOX
injection. Participants will then be evaluated at 1.5 months, 3 months and 6 months with
fiberoptic examination as well as Voice Handicap Index & Reflux Symptom Index. Participants
in the medication only arm who continue to have a granuloma at 3 months will receive a BOTOX
injection. They will be re-evaluated 3 months after the injection. Examinations will be
recorded and reviewed by blinded reviewers.
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
We found this trial at
1
site
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
Click here to add this to my saved trials
