Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures: A Study Protocol for a Matched Case-Control and Self-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- ABR testing
研究概览
简要总结
The goal of this clinical trial is to learn if acupuncture works to treat chronic tinnitus in adults. It will also learn about the neurophysiological effects of acupuncture on auditory conduction pathway function. The main questions it aims to answer are:
Does acupuncture lower tinnitus-related disability and severity, as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Effects Questionnaire (TEQ)?
What changes in auditory brainstem response (ABR) parameters-such as wave I amplitude and wave V latency-occur after acupuncture treatment, and do these changes correlate with clinical improvement?
Researchers will compare ABR parameters and clinical outcomes between chronic tinnitus patients and age- and sex-matched healthy controls to characterize tinnitus-related abnormalities. Additionally, the study will evaluate changes within the patient group before and after a 10-session acupuncture course to assess treatment efficacy and explore its neurophysiological mechanisms.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 60 years, inclusive, any sex;
- •No previous chronic functional or organic diseases, no head injury;
- •No history of any psychiatric or neurological family genetic disease;
- •Signed a paper version of the informed consent form and volunteered to participate in this trial.
排除标准
- •Pregnant or breastfeeding women, and those who have a request for childbearing within the last six months;
- •History of head trauma;
- •Presence of metallic implants in the body or any other contraindication to ABR testing;
- •Current participation in any other interventional clinical trial.
研究组 & 干预措施
Acupuncture group
干预措施: Acupuncture (Other)
结局指标
主要结局
ABR testing
时间窗: Enrolment, Week 5
Tinnitus Handicap Inventory
时间窗: Enrolment, Week 5, Week 13
次要结局
- Tinnitus effects questionnaire(Enrolment, Week 5, Week 13)
研究者
Shiyu Zhang
resident physician
The Third Affiliated hospital of Zhejiang Chinese Medical University