Effectiveness of Acupuncture for Phonotraumatic Injuries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Acupuncture for Phonotraumatic Injuries

Conditions
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Phonotraumatic Injuries

Intervention / Treatment
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* Procedure: Traditional Chinese acupuncture
* Procedure: Placebo acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; age 20-55 yr Exclusion Criteria: no prior voice therapy; no medication or therapy that may affect voice during the period of participation; no acupuncture treatment for any condition within the preceding 10 year; 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Traditional acupuncture | Procedure: Traditional Chinese acupuncture<br>* Acupuncture at two Hegu (LI4) and two Lieque (Lu7) points on the wrist, one Lianquan (CV23) and two Renying (St9) points on the neck and two Zhaohai (Ki6) for 12 30-minute sessions<br>* Other names: Ordinary acupuncture;|
| Sham Comparator: Placebo<br>Placebo acupuncture | Procedure: Placebo acupuncture<br>* Placebo acupuncture at two Hegu (LI4) and two Lieque (Lu7) points on the wrist, one Lianquan (CV23) and two Renying (St9) points on the neck and two Zhaohai (Ki6) for 12 30-minute sessions.<br>|
| No Intervention: No-treatment<br>no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice Activity and Participation Profile |  | Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment |