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针刺治疗慢性耳鸣的外周-中枢相关性研究:一项随机对照试验的研究方案

Peripheral-central correlation study of acupuncture for chronic tinnitus study protocol for a randomized controlled trial.

作者信息

Jiang Da, Huang Xiao-Han, Fang Ke, Zhao Ming-Hui, Li Yang, Hu Han-Tong, Fang Lian-Qiang, Gao Hong, Zhou Jie

机构信息

Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.

出版信息

Front Med (Lausanne). 2025 Feb 13;12:1543023. doi: 10.3389/fmed.2025.1543023. eCollection 2025.

Abstract

PURPOSE

(1) Exploring the evaluation and correlation of peripheral central auditory function in patients with chronic tinnitus. (2) Evaluation of the cumulative effect of acupuncture on peripheral central auditory function in patients with chronic tinnitus.

METHOD

Our research is structured as a regulated and randomized trial with assessor blinding. Seventy-two participants who qualify with chronic tinnitus will be allocated in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. Additionally, we will recruit 15 healthy individuals as subjects for data collection to observe the correlation of peripheral-central auditory function under different physiological states.

RESULT

Clinical result metrics encompass the Tinnitus Handicap Inventory (THI), ABR testing, and fNIRS data collection. Evaluations will be carried out at baseline, after 10 treatment sessions.

CONCLUSION

This research are anticipated to improve our comprehension of the effectiveness and fundamental processes of acupuncture in addressing persistent tinnitus and deeply explain the mechanism of action of the acupuncture method on chronic tinnitus.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT06401993.

摘要

目的

(1)探究慢性耳鸣患者外周与中枢听觉功能的评估及相关性。(2)评估针刺对慢性耳鸣患者外周与中枢听觉功能的累积效应。

方法

本研究为有评估者盲法的随机对照试验。72名符合慢性耳鸣标准的参与者将按1:1比例分配至针刺组或假针刺组。此外,我们将招募15名健康个体作为数据收集对象,以观察不同生理状态下外周与中枢听觉功能的相关性。

结果

临床结果指标包括耳鸣障碍量表(THI)、听性脑干反应(ABR)测试和功能近红外光谱(fNIRS)数据收集。评估将在基线、10次治疗后进行。

结论

本研究有望增进我们对针刺治疗持续性耳鸣有效性及基本过程的理解,并深入阐释针刺法治疗慢性耳鸣的作用机制。

临床试验注册

ClinicalTrials.gov,标识符NCT06401993。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/029d/11865056/4ecd8a5b62ff/fmed-12-1543023-g001.jpg

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