Effects of Acute Electroacupuncture Therapy Versus Transcutaneous Electrical Nerve Stimulation as Adjunctive Treatment for Sudden Sensorineural Hearing Loss: A Preliminary Study

National Research Council of Thailand (NRCT)0 个研究点目标入组 80 人开始时间: 2012年6月26日最近更新: 2016年8月13日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 80
主要终点: Improvement of hearing threshold

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To evaluate the effects of Electroacupuncture (EA) and compare its therapeutic efficacy to Trancutaneous electrical nerve stimulation(TENS) and conventional medical therapy in cases of ISSHL

研究设计

研究类型: Interventional
主要目的: 随机交叉对照

入排标准

年龄范围: 18 至 80（—）
性别: All

入选标准

•Male or female, age > 18 to 80 years and legal age of consent;
•Has diagnosis of first episode of unilateral sudden sensorineural hearing loss;
•Audiogram shows sensorineural hearing loss > 30 dB at least 1 frequency of the affected ear, and if the subject is older than 50 years old; the hearing threshold of the contralateral ear must be 10 dB less the affected ear.

排除标准

•History of head injury, loud noise exposure, use of ototoxic drugs, infections of middle ears, brain infections;
•History of coagulation defects or receive anticoagulants/ antiplatelets;
•History of epilepsy, seizure, stroke, cerebral ischemia, or has cardiac pacemakers;
•Immunocompromised status, including a debilitated state or Malignancy;
•Physical examination and laboratory results reveal following findings: Vesicles at pinna, ear canal, or tympanic membrane/ Perforated tympanic membrane/ Fluid in middle ear space/ CNS abnormality/ Abnormal VDRL or TPHA/ Significant prolonged PT, PTT, INR;
•MRI or CT scan shows structural abnormality of brain and auditory nerve;
•Lack of ability or willingness to give informed consent.

研究组 & 干预措施

I. Conventional medical treatment

Hearing threshold (dB)

II. Electroacupuncture

Electroacupuncture

结局指标

主要结局

Improvement of hearing threshold

次要结局

未报告次要终点

研究者

发起方

National Research Council of Thailand (NRCT)

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