Study protocol for a randomized controlled trial comparing penetrating needling and cognitive behavioral therapy for subjective tinnitus

Objective To describe the protocol for a randomized controlled trial designed to evaluate the clinical efficacy of penetrating needling compared with cognitive behavioral therapy (CBT) in patients with subjective tinnitus. Methods This protocol describes a proposed assessor- and analyst-blinded, parallel-group randomized controlled trial. A total of 72 participants will be randomized 1:1 to a treatment group receiving penetrating needling plus health education or a control group receiving CBT plus health education. Penetrating needling will be administered five times weekly for two consecutive weeks (10 sessions). The primary outcomes are the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), and a Visual Analogue Scale (VAS) for tinnitus loudness. Secondary outcomes include the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Depression Scale (HAMD), and the Hamilton Anxiety Scale (HAMA). Outcomes will be assessed at baseline, after one week of treatment, after two weeks of treatment, and at a 4-week follow-up (by telephone, online, or in clinic). Conclusion As CBT is an established standard of care, this proposed parallel-group trial is designed to specifically evaluate the efficacy of penetrating needling. The findings of this protocol are expected to provide rigorous, high-quality evidence to determine the viability of penetrating needling as a neuromodulatory alternative for subjective tinnitus. Clinical trial registration http://itmctr.ccebtcm.org.cn/ , ITMCTR2024000264.