Back to resultsEffectiveness of Acupuncture for Phonotraumatic Injuries
Primary Purpose
Phonotraumatic Injuries
Status
Unknown status
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Traditional Chinese acupuncture
Placebo acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Phonotraumatic Injuries
Eligibility Criteria
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.
Sites / Locations
- Voice Research Laboratory, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Experimental
Placebo
No-treatment
Arm Description
Traditional acupuncture
Placebo acupuncture
no treatment
Outcomes
Primary Outcome Measures
Maximum fundamental frequency of the voice range profile
Secondary Outcome Measures
Voice Activity and Participation Profile
Full Information
NCT ID
NCT00803582
First Posted
December 4, 2008
Last Updated
January 20, 2010
Sponsor
The University of Hong Kong
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00803582
Brief Title
Effectiveness of Acupuncture for Phonotraumatic Injuries
Official Title
Effectiveness of Acupuncture for Phonotraumatic Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phonotraumatic Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Traditional acupuncture
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Placebo acupuncture
Arm Title
No-treatment
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Procedure
Intervention Name(s)
Traditional Chinese acupuncture
Other Intervention Name(s)
Ordinary acupuncture
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Placebo acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Kwong, PhD
Phone
(852)28590572
Email
jasperek@graduate.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Yiu, Prof
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Voice Research Laboratory, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Kwong
Email
jasperek@graduate.hku.hk
12. IPD Sharing Statement
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Effectiveness of Acupuncture for Phonotraumatic Injuries
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