Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 23, 2024
Date Accepted: Apr 22, 2025
Combination of Electroacupuncture and Medication for Patients with Tinnitus Associated with Idiopathic Sudden Sensorineural Hearing Loss: Pilot Study Protocol for a Prospective Randomized Controlled Trial.
ABSTRACT
Background:
The etiology of idiopathic sudden sensorineural hearing loss(ISSNHL) accompanied by tinnitus remains unclear. Tinnitus often occurs alongside or before hearing loss and can severely impact patients' quality of life, leading to psychological stress and emotional distress. Current treatments primarily focus on improving hearing loss while neglecting the treatment of tinnitus. Electroacupuncture has been widely used in China for the clinical treatment of tinnitus over a long period; however, due to a lack of high-quality clinical trials, it has not yet been recommended in treatment guidelines. Studies indicate that electroacupuncture may exert its effects by activating connections within various brain networks.
Objective:
This study aims to explore the efficacy of electroacupuncture combined with medication in treating ISSNHL with tinnitus and to provide evidence-based support for electroacupuncture treatment of this condition.
Methods:
A double-center, assessor-blinded, prospective randomized clinical trial was designed. All participants will be randomly assigned to two groups according to the order of visits after signing the informed consent. The sample size is set at 20-25 participants per group for an exploratory clinical trial, with an additional 20% to account for attrition, resulting in a total recruitment target of 60 participants. The control group will receive standard medication treatment, while the acupuncture group will receive electroacupuncture combined with medication for a total treatment duration of 4 weeks. Follow-up assessments will be conducted at week 2, week 4, and Post1month, Post2months, Post3months. Treatment outcomes will be evaluated using pure tone audiometry, Tinnitus matching, Tinnitus Handicap Inventory, speech recognition thresholds in noise, Self-Rating Anxiety Scale and Short Form 36 Health Survey Questionnaire.
Results:
This trial was funded in December 2023. Participant recruitment begins on July 15, 2024, and is expected to end on August 30, 2025. Interventions begin in August 2024. Data collection will end by November 30, 2025, and statistical analysis will be completed by December 31, 2025. The results are expected in February 2026.
Conclusions:
The trial results will assess whether electroacupuncture combined with standardized medication is more effective than medication alone in treating ISSNHL with tinnitus.If the results confirm its efficacy, we plan to initiate larger-scale, multicenter clinical trials. Clinical Trial: The pilot study protocol has been registered on the Chinese Clinical Trial Registry https://www.chictr.org.cn. Registration number: ChiCTR2400086802. Registered 11 July 2024.
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