Effects of Vocal Exercises for Spasmodic Dysphonia

NCT ID: NCT03349086

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-28
• Study Completion Date: 2018-07-25

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.

Conditions

Adductor Spasmodic Dysphonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Voice Exercise

Intervention Type: BEHAVIORAL

Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.

Voice Rest

Randomized participants in this group will undergo 45 minutes of voice rest.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Voice Exercise

Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brienne Ruel, MS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin - Madison

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2013-1746

Identifier Type: -

Identifier Source: org_study_id