FR-taVNS Tinnitus Tria

This is a three‐arm parallel, repeated‐measures randomized controlled trial conducted inthe otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital.Eligible non‐cancer adults with tinnitus as the sole chief complaint and normal pure‐tonethresholds are stratified by age and sex, then randomized by computer‐generated randomnumber tables to the FR group, the ta‐VNS group, or the usual‐care control group; the FRand ta‐VNS groups are further randomized to true or sham subgroups. The foot reflexologyintervention is delivered once weekly for 20 minutes over four sessions (one month) andcomprises a relaxation phase, an inner‐ear/autonomic regulation phase, and acirculation/detoxification phase; the sham condition applies light, non‐specific touch.The ta‐VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae(pulse width 250 µs, 25 Hz, 0.5‐5 mA individualized to a tingling sensation, 30 s on/off)once weekly for 20 minutes over four weeks; the sham condition stimulates the leftearlobe at 0.5 mA. Auricular acupressure with magnetic beads is self‐administered threetimes daily. Outcomes are assessed at T0 (baseline), T1 (week 2), T2 (week 4), and T3(week 8). Data are analyzed with generalized estimating equation (GEE) models.