Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

Study Overview
=================
Brief Summary
-----------------
Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The specific aim of this study is to determine the effectiveness of of a short course of oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.

Detailed Description
-----------------
The study will investigate the potential added advantage of the use of steroids in patients undergoing voice therapy. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The measurements that will be collected in all these phases are the Voice Handicap Index (VHI)-10 , the noise to harmonic ratio H/N, the fundamental frequency Fo, The transglottic airflow and subglottic pressure. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.

Official Title
-----------------
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

Conditions
-----------------
Dysphonia

Intervention / Treatment
-----------------
* Drug: Steroid
* Dietary Supplement: Lactose Pills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 males and females Presence of phonotraumatic lesion deemed to be etiologic for the complaint of dysphonia Voice therapy deemed to be the primary (or at least initial) treatment to address the dysphonia. Willingness to be an active participant in voice therapy. Exclusion Criteria: Use of any glucocorticoids (oral, inhaled, or intravenous) within 3 months of the initial evaluation Known allergy or hypersensitivity to oral steroids Active infection Diabetes Mellitus Prior history of radiation to the neck Recent myocardial infarction Recent gastrointestinal surgery with bowel anastamosis (3 months) Active peptic ulcer Pregnancy Severe depression or history of psycosis History of recent laryngeal surgery (within 12 months)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid<br>Prednizone pills. 4 day course 2 x 20mg per day. | Drug: Steroid<br>* A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.<br>* Other names: Prednizone;|
| Placebo Comparator: Placebo<br>Lactose Pills. 4 day course 2 x 20mg per day. | Dietary Supplement: Lactose Pills<br>* 4 day course 2 x 20mg per da<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months | Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable. | pre-treatment/baseline to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lesion Size From Baseline to 2 Months | Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold. | pre-treatment/baseline to 2 months | 
| Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months. | A change in VHI scores from pre-treatment to following treatment. Scores can range from 0-120: 0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen | Pre-treatment/baseline to following treatment/2 months | 
| Number of Participants That Showed Improved (Lower) Average Decibels (db) Output. |  | 2 months |