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Effects of Vocal Exercises for Spasmodic Dysphonia

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ClinicalTrials.gov Identifier: NCT03349086
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Adductor Spasmodic Dysphonia Behavioral: Voice Exercise Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Vocal Exercise Following Botox Injection on Voice Handicap and Communicative Participation for Adductor Spasmodic Dysphonia
Actual Study Start Date : July 28, 2014
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Voice Exercise
Randomized participants in this group will undergo 45 minutes of voice exercise, including sustained pitches and pitch glides on a variety of different vocal facilitators.
Behavioral: Voice Exercise
Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.

No Intervention: Voice Rest
Randomized participants in this group will undergo 45 minutes of voice rest.



Primary Outcome Measures :
  1. 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. [ Time Frame: Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 year. ]

    Pre randomized condition and post 6 week and 12 week, participants will be asked to complete the Voice Handicap Index (VHI).

    The VHI Questionnaire (Voice Handicap Index) is a 30-item questionnaire divided into 3 subsections (Functional, Physical, Emotional) and a Total which measures the effect of voice problems on quality of life. Individuals mark each item on this 30-item questionnaire on a scale from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered Normal, 12-28 is considered Mild Minimal handicap, 29-56 is considered Moderate Handicap, and 57-120 is considered severe handicap.




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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349086


Locations
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Brienne Ruel, MS University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03349086     History of Changes
Other Study ID Numbers: 2013-1746
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
Botox Injection
Spasmodic
Dysphonia
Voice Therapy
Speech Therapy
Voice Rest

Additional relevant MeSH terms:
Dysphonia
Hoarseness
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory