The Clinical Efficacy of Stretch-and-Flow Voice Therapy for Muscle Tension Dysphonia: A Multi-Center Randomized Clinical Trial

Study ID
STU 062012-103

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Kristy Carter
214-648-3626
kristy.carter@utsouthwestern.edu

Principal Investigator
I-Fan Mau

Summary

This is a cooperative multi-center randomized clinical trial involving three institutions in the DFW metroplex. Texas Christian university (TCu) is the lead institution and is responsible for project initiation, coordination, and data analysis. Patient recruitment and voice therapy will take place at two voice centers, the uTSW Voice Center, and the Wane D. Tidwell Voice and Swallowing Center of Baylor institute for Rehabilitation in Fort Worth. Subjects will be randomized into two treatment arms. one group will undergo SFVT, and the other will undergo RVT. Treatment phases for both groups will consist of weekly (1 x per week) voice therapy sessions over six weeks for a total of six therapy sessions. The outcome variables consist of the following:
- patient self-rating of voice handicap (Voice Handicap index-VHi)
- clinician-rated perceptual voice qualities (Consensus auditory - Perceptual evaluation of Voice -CaPe-V)
- acoustic measures of voice recordings (Cepstral-Spectral index of Dysphonia -CSiD))
- aerodynamic measures of phonation (maximum vowel prolongation time, s/z ratio)
- Videostroboscopic recordings of sustained vowel

Participant Eligibility


* Adult (21yrs or above)

* Primary diagnosis of functional voice disorder due to excessive and/or imbalanced muscle tension (a.k.a., muscle tension dysphonia), without concurrent vocal fold lesions or neurological conditions involving the larynx, where voice therapy is recommended as the first stage of management.

* Signs and symptoms of current voice problem present for at least 2 weeks. Diagnosis confirmed by speech-language pathologist via clinical voice evaluation AND Otolaryngologist via assessment of laryngeal videostroboscopy (i.e., to rule out primary diagnosis of organic/neurological disorder).

* Presence of dysphonia perceptible and confirmed via auditory-perceptual assessment by clinician.

* Degree of dysphonic severity at pre-treatment must be > 20 on a 100mm visual analog scale rating of Overall Severity (mirroring CAPE-V scale).