Effectiveness of Acupuncture for Phonotraumatic Injuries

Phase 2

• Conditions: Phonotraumatic Injuries
• Interventions: Procedure: Traditional Chinese acupuncture; Procedure: Placebo acupuncture

• Registration Number: NCT00803582
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

The experimental hypothesis for this study is that needling at the designated treatment acupoints will bring about greater improvement in structural and functional impairment in the vocal folds and its sequelae, as compared to placebo treatment. However, it is further hypothesized that treatment benefits from acupuncture will be outweighed by continued phonotrauma following termination of treatment, and thus will not be maintained at long-term follow-up. Further, it is expected that voice-related quality-of-life improvements may be equal for genuine acupuncture as compared to placebo. Finally, it is hypothesized that the acupuncture protocol should have comparable effects for male and female subjects.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-20
• Last Update Posted: 2010-01-22
• Primary Completion: 2010-02
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental	Traditional Chinese acupuncture	Traditional acupuncture
Placebo	Placebo acupuncture	Placebo acupuncture

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Voice Activity and Participation Profile	Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment

Trial Locations

Locations (1)

Voice Research Laboratory, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong