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

Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures: A Study Protocol for a Matched Case-Control and Self-Controlled Trial

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.

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.