Evaluating the Efficacy and Underlying Mechanisms of Acupuncture for Chronic Subjective Tinnitus Using Functional Near-Infrared Spectroscopy: Study Protocol for a Randomized Controlled Trial

Abstract

Objective

This study aims to evaluate the efficacy and safety of acupuncture for chronic subjective tinnitus and explore the central mechanism underlying acupuncture for chronic subjective tinnitus using functional near-infrared spectroscopy (fNIRS).

Methods

We will randomly assign 60 tinnitus patients to either an acupuncture group or a waiting-list control group. The acupuncture group will undergo 12 treatment sessions over 4 weeks, whereas the waiting-list control group will receive no intervention concurrently. Clinical outcome measures include the Tinnitus Handicap Inventory (THI) score, tinnitus loudness assessed by 11-point NRS, average pure-tone threshold, and Hamilton Anxiety Scale (HAM-A) score. Neuroimaging outcomes assessed by fNIRS included blood oxygen concentration and resting-state functional connectivity (RSFC). All outcome measurements will be assessed at the baseline, after 4-week treatment, and at 3-month follow-ups.

Results

Our investigation will determine if significant differences exist between the two groups regarding THI, NRS, average pure-tone threshold, and HAM-A scores. Moreover, the analysis will reveal whether the acupuncture group demonstrates significant change in blood oxygen concentration and RSFC between specific brain regions compared to the waiting-list control group.

Conclusion

With the novel technique of fNIRS, in addition to efficacy evaluation of acupuncture, this study’s findings are anticipated to partly elucidate the neural mechanisms underlying acupuncture treatment for subjective tinnitus and offer an objective assessment method for its therapeutic impact, thereby contributing to filling the research gap.

Trial Registration

Clinicaltrials registry (identification code NCT05829278).

Keywords:

• acupuncture
• functional near-infrared spectroscopy
• randomized controlled trial
• subjective tinnitus
• neural mechanisms

Ethics Approval and Consent to Participate

This clinical trial will adhere to the Declaration of Helsinki guidelines during its implementation and ethics approval (grant number: ZSLL-KY-2022-042-01) has been obtained from the Institutional Ethical Review Board of the Third Affiliated Hospital of Zhejiang Chinese Medical University. Prior to participation, all subjects in the study are required to provide informed consent.

Acknowledgments

Hantong Hu and Xiaoqi Lin are co-first authors for this study. The authors appreciate the support from all participants who have been or will be included in this study.

Disclosure

The authors declare that they have no competing interests in this work.

Additional information

Funding

This study is funded by the Zhejiang Province Public Welfare Technology Application Research (LTGY23H270003); Zhejiang Provincial Famous Traditional Chinese Medicine Experts Inheritance Studio Construction Project (GZS2021027); Zhejiang Natural Science Foundation Exploration Project Q (LQ20H270012); and Zhejiang Traditional Chinese Medicine Technology Plan (2020ZB124, 2021ZX010).