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评价声治疗联合针刺治疗特发性耳鸣的疗效:一项随机对照试验方案。

Evaluation of the therapeutic effect of acoustic therapy combined with acupuncture on idiopathic tinnitus: A randomized controlled trial protocol.

机构信息

The Department of Otorhinolaryngology, The First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.

出版信息

Medicine (Baltimore). 2021 Jan 22;100(3):e23883. doi: 10.1097/MD.0000000000023883.

Abstract

BACKGROUND

: There is no effective treatment for idiopathic tinnitus. Both acoustic therapy and acupuncture have been used in the treatment of idiopathic tinnitus, but the clinical efficacy is quite different. For there is no clinical study combining the 2, the purpose of this randomized controlled trial is to evaluate the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus.

METHODS

: This is a prospective randomized controlled trial to study the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus, and is approved by the clinical research ethics committee of our hospital. The patients are randomly divided into one of 2 treatment options: (A) acoustic therapy combined with acupuncture group and (B) simple acupuncture group. Patients, doctors, nurses, and data collection assistants are blinded to group allocation. Observation indicators include: 1. Tinnitus Disability Scale; 2. Loudness visual analog scale; 3. Adverse reactions. Data is analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).

DISCUSSION

: This protocol will evaluate the efficacy and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus. The results of this experiment will provide clinical evidence for the use of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus.

TRIAL REGISTRATION

: This study protocol is registered in

ETHICS AND DISSEMINATION

: Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required.

OSF REGISTRATION NUMBER

: DOI 10.17605/OSF.IO/87VFB.

摘要

背景

目前尚无治疗特发性耳鸣的有效方法。声治疗和针灸都已应用于特发性耳鸣的治疗,但临床疗效差异较大。由于目前尚无联合这两种方法的临床研究,因此本随机对照试验的目的是评估声治疗联合针灸治疗特发性耳鸣的有效性和安全性。

方法

这是一项前瞻性随机对照试验,旨在研究声治疗联合针灸治疗特发性耳鸣的有效性和安全性,并获得了我院临床研究伦理委员会的批准。患者被随机分为以下两种治疗方案之一:(A)声治疗联合针灸组和(B)单纯针灸组。患者、医生、护士和数据收集助理均对分组情况不知情。观察指标包括:1.耳鸣残疾量表;2.响度视觉模拟量表;3.不良反应。数据采用 SPSS 版本 25.0(芝加哥,IL)统计软件包进行分析。

讨论

本方案将评估声治疗联合针灸治疗特发性耳鸣的疗效和安全性。该实验的结果将为声治疗联合针灸治疗特发性耳鸣提供临床证据。

试验注册

本研究方案在 OSF 注册,注册号为 DOI 10.17605/OSF.IO/87VFB。

伦理和传播

不会公布个人的隐私信息。本系统评价也不会危及参与者的权利。因此,不需要伦理批准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/279f/7837873/a38f5a28a0f9/medi-100-e23883-g001.jpg

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