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Effectiveness of Acupuncture for Phonotraumatic Injuries

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00803582
First received: December 4, 2008
Last updated: January 20, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Phonotraumatic Injuries
 Procedure: Traditional Chinese acupuncture
Procedure: Placebo acupuncture
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture for Phonotraumatic Injuries

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Maximum fundamental frequency of the voice range profile [ Time Frame: Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Voice Activity and Participation Profile [ Time Frame: Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: February 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Traditional acupuncture
 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
Other Name: Ordinary acupuncture
Sham Comparator: Placebo
Placebo acupuncture
 Procedure: 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.
Other Name: Placebo acupuncture
No Intervention: No-treatment
no treatment

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803582

Contacts
Contact: Elaine Kwong, PhD (852)28590572 jasperek@graduate.hku.hk

Locations
Hong Kong
Voice Research Laboratory, The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Elaine Kwong         jasperek@graduate.hku.hk    
Sponsors and Collaborators
The University of Hong Kong
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Edwin Yiu, Prof The University of Hong Kong
  More Information

No publications provided

Responsible Party: Prof Edwin Yiu, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00803582     History of Changes
Other Study ID Numbers: R21 AT003879, R21AT003879, Acu_R21_1
Study First Received: December 4, 2008
Last Updated: January 20, 2010
Health Authority: United States: Federal Government
Hong Kong: Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster

ClinicalTrials.gov processed this record on May 19, 2013