Phonotraumatic Injuries Clinical Trial
Official title:
Effectiveness of Acupuncture for Phonotraumatic Injuries
The purpose of this study is to investigate the efficacy of acupuncture for the treatment of phonotraumatic lesions of the vocal folds, using the International Classification of Functioning Disability and Health (World Health Organization, 2001) as the conceptual framework to guide the selection of outcome measures.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Otolaryngological diagnosis within the preceding 15 days of swelling or thickening of at least one vocal fold, or nodules, fibrous mass, cyst, polyp, or chronic (non-infectious) laryngitis, which by history are traceable to phonotrauma and by history appear stable or worsening; 2. age 20-55 yr Exclusion Criteria: 1. no prior voice therapy; 2. no medication or therapy that may affect voice during the period of participation; 3. no acupuncture treatment for any condition within the preceding 10 year; 4. no diagnosed or suspected neurological conditions, hearing loss (i.e. hearing threshold of the better ear not exceeding 35dB HL at 250 Hz, 500 Hz, 1000 Hz, 4000 Hz and 8000 Hz), history of asthma, and no upper respiratory infection at the time of recruitment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Voice Research Laboratory, The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | National Center for Complementary and Integrative Health (NCCIH) |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum fundamental frequency of the voice range profile | Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment | No | |
Secondary | Voice Activity and Participation Profile | Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment | No |