Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Condition: Dysphonia
MeSH terms: Dysphonia
Intervention: Steroid; Lactose Pills
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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)