Clinical trial NCT03349086: Effects of Vocal Exercises for Spasmodic Dysphonia
Official title: Effects of Vocal Exercise Following Botox Injection on Voice Handicap and Communicative Participation for Adductor Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adductor Spasmodic Dysphonia
Keywords: Botox Injection
Spasmodic
Dysphonia
Voice Therapy
Speech Therapy
Voice Rest
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 15
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will undergo one of two study conditions immediately following a standard of care Botox injections. One condition is a 45 minute voice rest condition and the other condition is a 45 minute voice exercise condition.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following Botox injections for adductor spasmodic dysphonia.

Detailed description: Spasmodic dysphonia (SD) is a neurological disorder characterized by involuntary spasms of the vocal folds resulting in a strained and strangled voice quality. This disorder is quite disabling to patients who suffer from it, particularly affecting patients' quality of life. Botulinum toxin (Botox) has been found to be the most effective treatment for SD. The Botox is injected into the affected muscle resulting in temporary weakening of the muscle. The patients return for injections on average every 3 - 6 months.

There is a suggestion in the literature that increased diffusion of the Botox injectate could improve the effects of the injection. Furthermore, there is literature supporting the use of exercise to increase the diffusion of the Botox. Previous research examined the use of voluntary muscle activity vs. rest immediately following Botox injection for writer's cramp. It was found that the active condition resulted in greater reduction of muscle strength in the injected muscle. Another small study of 9 patients implemented intense exercise comprised of loud reading for one hour and a rest condition of total voice rest for 24 hours. They found that the exercise condition resulted in improved scores on the voice related-quality of life (V-RQOL) measure and concluded that improvement in results of Botox injections may be achieved more consistently with the implementation of exercise following the injection. The exercise used in this study was intense and may be contrary to the overall benefit as the subjects may experience phonotrauma. Timing of the exercise post-injection may also be a factor. Previous literature review revealed combined modality treatment of Botox injection only, Botox with therapy and Botox with sham treatment. They found no significant differences in acoustic stability, V-RQOL, or duration of injection benefit. However, the exercise was initiated 3 weeks post-injection and completed once per week for 5 weeks. Investigators aim to identify what might improve or extend the duration of botox injections for adductor Spasmodic dysphonia.

Eligibility criteria: Inclusion Criteria:

1. Female
2. 21-70 age
3. Diagnosed with pure adductor spasmodic dysphonia
4. Completed 2 consecutive standard of care Botox injection into the thyroarytenoid (TA) and/or thyroarytenoid/lateral cricoarytenoid (TA/LCA) junction with the same dosage

Exclusion Criteria:

1. Receiving Botox to other laryngeal or supraglottic musculature
2. Other neuro-laryngological conditions
3. Those with an average of less than two injections per year

Primary outcomes:
measure: A quantifiable difference between the effects of voice exercise vs. voice rest post Adductor Spasmodic Dysphonia botox treatment through analysis of the Voice Handicap Index Questionnaire.
timeFrame: Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Brienne Ruel, MS
role: PRINCIPAL_INVESTIGATOR
References: