Electroacupuncture with or without combined warm needling for tinnitus: Study protocol for a randomized, waitlist-controlled trial

Background: Tinnitus is a common auditory condition that can lead to serious problems. Clinically, acupuncture and moxibustion have been commonly applied to treat tinnitus in China, with potential therapeutic effects but with limitations in study methodology and high-quality evidence. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of either electroacupuncture alone or combined with warm needling for reducing tinnitus loudness and improving quality of life. Methods: This study is a prospective, multicenter, assessor-blind, 3-arm, parallel-group, randomized, waitlist-controlled trial. In total, 90 patients will be randomly assigned to the electroacupuncture, electroacupuncture and warm needing, or waitlist control group in a 1:1:1 ratio. Patients in the 2 treatment groups will be treated twice a week for a total of 5 weeks. Patients in the control group will not receive treatment during the study period and will be informed that they can receive it for free after a 10-week waiting period. The duration of intervention for this study will be 5 weeks, followed by another 5 weeks for the posttreatment assessment. The primary outcome is the change in the visual analog scale score for tinnitus loudness from baseline until the end of treatment. The secondary outcome is the tinnitus discomfort assessment measured using the Tinnitus Handicap Inventory. Outcome parameters will be assessed at baseline and at weeks 5 and 10. Any adverse events will be observed and recorded for safety assessment. Linear mixed models for repeated measures will be applied in the analysis. Discussion: Acupuncture and moxibustion could be potentially effective treatment alternatives for tinnitus. The study results will provide evidence to determine the efficacy and safety of electroacupuncture with or without warm needling for tinnitus.