Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS: Study Protocol for a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in resting-state functional connectivity (RSFC)
研究概览
简要总结
This randomized controlled pilot trial aims to explore the Efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus using functional near-infrared spectroscopy (fNIRS).
详细描述
A total of 60 tinnitus patients were randomly assigned to either an acupuncture group or a waiting list group in a 1:1 ratio. Subjects in the acupuncture group will undergo 4-week acupuncture treatment, while subjects in the waiting list group will receive no treatment during the 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.
- •Male and female, Aged between 18 and 60 years.
- •Participants can cooperate with experimental procedures and sign written inform consent.
- •Not participating in other clinical trials concurrently.
排除标准
- •Participants with objective tinnitus
- •Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by resting-state functional connectivity.
- •Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.
- •Participants have any contraindications for acupuncture (such as a bleeding tendency)
- •Pregnant or lactating women.
- •Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.
结局指标
主要结局
Change in resting-state functional connectivity (RSFC)
时间窗: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Change in hemoglobin signals
时间窗: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
次要结局
- Change in Tinnitus Handicap Inventory score(at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up)
- Change in average pure-tone threshold(at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up)
- Change in Hamilton Anxiety Scale score(at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up)
- Change in tinnitus loudness(at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up)
研究者
Hantong Hu
Principal Investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University