Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Condition: Dysphonia
MeSH terms: Dysphonia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Steroid; Lactose Pills
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.; 4 day course 2 x 20mg per da
Other intervention name(s): Prednizone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment