Effectiveness of Acupuncture for Phonotraumatic Injuries

NCT00803582 | Unknown Phase 2 DMC

• 2 other identifiers: R21AT003879Acu_R21_1
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Phonotraumatic Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Voice Activity and Participation Profile

  Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment

Study Arms (3)

Experimental

EXPERIMENTAL

Traditional acupuncture

Procedure: Traditional Chinese acupuncture

Placebo

SHAM COMPARATOR

Placebo acupuncture

Procedure: Placebo acupuncture

No-treatment

NO INTERVENTION

no treatment

Interventions

Traditional Chinese acupuncture PROCEDURE

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

Also known as: Ordinary acupuncture

Experimental

Placebo acupuncture PROCEDURE

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Voice Research Laboratory, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Edwin Yiu, Prof

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Kwong, PhD

CONTACT

(852)28590572; jasperek@graduate.hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 22, 2010

Record last verified: 2010-01

Locations

HK (1)