Effectiveness of Acupuncture for Phonotraumatic Injuries

The University of Hong Kong (HKU)

Status and phase: Unknown; Phase 2

Conditions: Phonotraumatic Injuries

Treatments: Procedure: Traditional Chinese acupuncture; Procedure: Placebo acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00803582

R21AT003879 (U.S. NIH Grant/Contract)

Acu_R21_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Experimental

Experimental group

Description:

Traditional acupuncture

Treatment:

Procedure: Traditional Chinese acupuncture

Placebo

Sham Comparator group

Description:

Placebo acupuncture

Treatment:

Procedure: Placebo acupuncture

No-treatment

No Intervention group

Description:

no treatment