Neck vibration plus voice therapy for muscle tension dysphonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, blinded, controlled Phase 3 trial comparing standard flow-phonation voice therapy delivered with local translaryngeal vibration versus the same therapy without vibration and exploring dose-response effects. Adults with primary muscle tension dysphonia and elevated voice handicap (VHI > 20) are enrolled and randomized to receive therapy with differing vibration doses or no vibration. Outcomes include patient-reported voice handicap and physiological voice measures collected before and after treatment to determine clinical benefit. The design uses rigorous blinding and standardized therapy procedures to isolate the effect of the vibration modality.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* a) diagnosis by an otolaryngologist of hyperfunctional dysphonia (MTD) without benign mid-membranous lesion (i.e., primary MTD or non-phonotraumatic hyperfunction) with and a recommendation for voice therapy, ((b) confirmation of dysphonia by a comprehensive voice evaluation conducted by a speech-language pathologist with experience in the evaluation and treatment of voice disordered populations, (c) to prevent floor effects of our primary outcome variable, participants will be required to exhibit a pre-treatment VHI score of \>20, as this is the upper range for normal cutoff values in studies which have demonstrated high sensitivity and specificity for this tool (Behlau et al., 2016), (d) 18 years of age or older, (e) no history of local vibration therapy as part of a rehabilitation treatment program.

Exclusion Criteria:

* Unable to receive vibration to neck area

Where it's running

• Texas Christian University
  Fort Worth, Texas, United States Recruiting

Study contacts

• Study coordinator: Christopher R Watts, Ph.D.
• Email: c.watts@tcu.edu
• Phone: 817-266-7891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.