A Preliminary Efficacy Study on the Effectiveness of Low-Level Light Therapy for Vocal Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Vocal Fatigue Measure: Vocal Fatigue Index (VFI-HK)
研究概览
简要总结
The goal of this phase 2 clinical trial is to examine the effectiveness of photobiomodulation in patients with vocal fatigue.
The main question it aims to answer is whether photobiomodulation is able to alleviate vocal fatigue in patients with diagnosed vocal fatigue.
Participants will ask to receive photobiomodulation treatment for 12 sessions over a three week period.
详细描述
Vocal fatigue is a common complaint of patients with voice disorder and is related to functional and/or organic voice disorders. Professional voice users, such as teachers and singers and actors, are particularly prone to vocal fatigue. It has been reported that vocal fatigue also associated with limitation to voice activities and participation. In patients with vocal fatigue, experience of inflammation and muscle pain are among possible symptoms and manifestations of the condition.
In literature, various definitions have been suggested for vocal fatigue. Welham and Maclagan defined vocal fatigue as the negative vocal adaptation led by prolonged use of voice, and it can consist of perceptual, acoustic or physiologic components of undesirable or unexpected functional changes in the laryngeal mechanism.
In exploring the nature of vocal fatigue, Titze capitalised on a generally recognised mechanism of muscle fatigue which comprised of a peripheral component and a central component. Specifically, for the peripheral component, fatigue may take place at the myo-neural junction, muscle membrane and endo-plasmic reticulum (i.e., the transmission mechanism) or the muscle filaments (i.e., the contractile mechanism), where depletion or accumulation of biochemical substances such as glycogen occurs.
Low-level light therapy (LLLT), also known as photobiomodulation (PBM) therapy, has been developed as a therapeutic procedure which involves the exposure to low levels of red and near infrared light to cells or tissues. It has been approved by the Food and Drug Administration (FDA) of the United States for aesthetic and medical purposes.
Ever since, it has been established as a non-invasive and safe approach for a number of medical processes, such as reducing inflammation, relieving pain, wound healing, skeletal muscle repair and treating neurological disorders. Specifically, its effectiveness on treating muscle fatigue was investigated with the focus placed on muscles such as bicep braquialis, quadriceps and orbicularis oris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18 years old
- •Meeting the diagnosis of vocal fatigue as per the VFI-HK
- •Able to make informed consent
- •Have not received any voice therapy before
排除标准
- •History of photoallergy
- •Significant medical or chronic diseases
结局指标
主要结局
Vocal Fatigue Measure: Vocal Fatigue Index (VFI-HK)
时间窗: This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).
The VFI(HK) contains 19 items in three domains (i) tiredness of voice and avoidance of voice use (ii) physical discomfort and (iii) improvement of symptoms after rest. All items are rated on a scale from zero (0, meaning "never") to four (4, meaning "always"). The score ranges from 0 to 76, with higher score indicating worst outcome.
次要结局
- Vocal function measure: Voice Handicap Index - 30(This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).)
- Vocal Function Measure: Aerodynamic assessment(This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).)
- Vocal Function Measures: Acoustic voice analysis(This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).)
研究者
Thomas Law
Assistant Professor
Chinese University of Hong Kong
