Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures

N/ANot Yet RecruitingNCT07522567

The Third Affiliated hospital of Zhejiang Chinese Medical University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tinnitus Acupuncture Auditory Brainstem Response

Interventions

AcupunctureOTHER

The acupoint prescription for this study was developed based on the clinical experience of senior acupuncturists and findings from previous related studies. The selected acupoints are as follow: Yifeng（both sides）、Tinggong（both sides）、Tinghui（both sides）、Zhongwan、Xiawan、Qihai、Guanyuan、Yindu（both sides），Shangqu（both sides）、Huaroumen（both sides）. The aforementioned acupoints will be needled on both sides because all recruited individuals have bilateral tinnitus. Licensed acupuncturists with over ten years of clinical experience in acupuncture and moxibustion will perform all treatments. All chronic tinnitus patients will receive a total of 10 acupuncture sessions, administered once every two days (three times per week) over a period of four weeks. Based on our prior research and clinical experience using acupuncture to treat tinnitus, we decided 10 acupuncture sessions in total.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 60 years, inclusive, any sex; 2. No previous chronic functional or organic diseases, no head injury; 3. No history of any psychiatric or neurological family genetic disease; 4. Signed a paper version of the informed consent form and volunteered to participate in this trial. Exclusion Criteria: 1. Pregnant or breastfeeding women, and those who have a request for childbearing within the last six months; 2. History of head trauma; 3. Presence of metallic implants in the body or any other contraindication to ABR testing; 4. Current participation in any other interventional clinical trial.

Outcomes

Primary Outcomes

ABR testing

Time frame: Enrolment, Week 5

Tinnitus Handicap Inventory

Time frame: Enrolment, Week 5, Week 13

Secondary Outcomes

Tinnitus effects questionnaire