Evaluation of the therapeutic effect of acoustic therapy combined with acupuncture on idiopathic tinnitus: A randomized controlled trial protocol

BACKGROUND: There is no effective treatment for idiopathic tinnitus. Both acoustic therapy and acupuncture have been used in the treatment of idiopathic tinnitus, but the clinical efficacy is quite different. For there is no clinical study combining the 2, the purpose of this randomized controlled trial is to evaluate the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus. METHODS: This is a prospective randomized controlled trial to study the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus, and is approved by the clinical research ethics committee of our hospital. The patients are randomly divided into one of 2 treatment options: (A) acoustic therapy combined with acupuncture group and (B) simple acupuncture group. Patients, doctors, nurses, and data collection assistants are blinded to group allocation. Observation indicators include: 1. Tinnitus Disability Scale; 2. Loudness visual analog scale; 3. Adverse reactions. Data is analyzed using the statistical software package SPSS version 25.0 (Chicago, IL). DISCUSSION: This protocol will evaluate the efficacy and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus. The results of this experiment will provide clinical evidence for the use of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus. TRIAL REGISTRATION: This study protocol is registered in ETHICS AND DISSEMINATION: Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/87VFB.