Effectiveness of Acupuncture for Phonotraumatic Injuries

Phonotraumatic Injuries Clinical Trial

Official title:

Effectiveness of Acupuncture for Phonotraumatic Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00803582
• Other study ID #: R21AT003879
• Secondary ID: R21AT003879Acu_R
• Status: Recruiting
• Phase: Phase 2
• First received: December 4, 2008
• Last updated: January 20, 2010
• Start date: February 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2010
• Source: The University of Hong Kong
• Contact: Elaine Kwong, PhD
• Phone: (852)28590572
• Email: jasperek[@]graduate.hku.hk
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentHong Kong: Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phonotraumatic Injuries

Intervention

Procedure:
• Traditional Chinese acupuncture
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
• Placebo acupuncture
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.

Locations

Country	Name	City	State
Hong Kong	Voice Research Laboratory, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

Hong Kong, 

Outcome

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