A Pilot Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Patients With Acute Tinnitus

BACKGROUND: This pilot study aimed to evaluate the feasibility effectiveness and safety of transcutaneous electrical nerve stimulation (TENS) for patients with acute tinnitus. METHODS: A total of 46 eligible patients with acute tinnitus were entered and included in this randomized controlled trial. All the included patients were equally and randomly divided into a verum TENS group and a sham TENS group, each group 23 participants. All patients received parenteral intramuscular therapy of 1 ml Vitamin B12 weekly for a total of 4 weeks. In addition, they also underwent verum or sham TENS 30 min daily, 3 times weekly for 4 weeks. The primary efficacy endpoint was measured by the Tinnitus Severity Scale (TSS) and Tinnitus Questionnaire (TQ) sum score. The secondary efficacy endpoints were assessed by the Tinnitus Handicap Inventory (THI), 12-Item Short Form Health Survey (SF-12) questionnaire, and adverse events. All outcome efficacy endpoints were measured at baseline and after 4 weeks of treatment. RESULTS: After 4-week treatment, the patients undergoing verum TENS showed statistically efficacy of symptoms relief, as measured by the scales of TSS (P < .01), TQ (P < .01), and THI (P < .01), and improvement of quality of life, as assessed by the SF-12 (P < .01), compared with patients receiving sham TENS. In addition, no adverse events related to the treatment were recorded in either group. CONCLUSIONS: The results of this study showed that verum TENS may benefit patients with acute tinnitus after 4 weeks of treatment.