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

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).