Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health