Acupuncture for chronic tinnitus: study protocol for a clinical trial with auditory brainstem response outcomes - Summary - MDSpire
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Clinical Trial Protocol for Evaluating Acupuncture's Effects on Chronic Tinnitus Using Auditory Brainstem Response Measurements

  • By

  • Shiyu Zhang

  • Minghui Zhao

  • Kaili Chen

  • Shenglu Xu

  • Keqin Ye

  • Lianqiang Fang

  • Hong Gao

  • September 10, 2026

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Objective:

To compare ABR parameters in patients with chronic tinnitus and healthy controls and examine whether clinical changes after acupuncture intervention coincide with alterations in auditory neurophysiological measures.

Approach:
  • Study Design: A prospective, two-part hybrid design including a matched case–control observational component and a longitudinal, self-controlled intervention component.
  • Participants: 36 patients with bilateral chronic tinnitus and 36 healthy controls matched for age and sex.
  • Intervention: Participants with tinnitus will receive 10 acupuncture treatments over 4 weeks.
  • Measurements: ABR testing will be performed at baseline and post-treatment; clinical outcomes will be measured using THI, TEQ, and Tinnitus-Related Visual Analog Scale.
Key Findings:
  • Baseline disparities in ABR parameters are expected between participants with chronic tinnitus and healthy controls.
  • Acupuncture-related symptom improvement may coincide with alterations in auditory neurophysiological measures.
Interpretation:

The study aims to provide preliminary evidence on the feasibility of using ABR as an objective outcome measure in tinnitus intervention studies.

Limitations:
  • The study is exploratory and may not provide definitive conclusions.
  • The sample size is relatively small, which may affect the generalizability of the findings.
Conclusion:

The protocol presents an exploratory clinical study to assess clinical and neurophysiological changes associated with acupuncture for chronic tinnitus.

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