Manual Acupuncture Versus Sham Acupuncture and Usual Care for Acute Primary Tinnitus: Multicentre, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
研究概览
简要总结
This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.
详细描述
This is a multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment and statistician. The total trial period will be 14 weeks, including two weeks of baseline assessment, four weeks of treatment, and eight weeks of follow-up. A total of 180 patients with acute primary tinnitus will be randomized in a 1:1:1 ratio to receive 10 sessions of manual acupuncture, 10 sessions of sham acupuncture, or usual care alone over 4 weeks. Informed consent will be obtained from each patient before randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded to intervention condition (manual avupuncture or sham acupuncture). Outcome assessors and data analysts are blinded to group allocation. Given the nature of acupuncture manipulation, acupuncturists in this trial are not blinded. However, acupuncturists does not take part in outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years, male or female;
- •Primary complaint is persistent tinnitus (unilateral or bilateral);
- •Meet the diagnostic criteria for primary tinnitus according to the 2014 Clinical Practice Guideline developed by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF);
- •Had continuous tinnitus ≥2 weeks and <6 months;
- •Tinnitus should be bothersome, with a screening THI score 28-76;
- •Acupuncture naive;
- •Able to provide written informed consent.
排除标准
- •Objective tinnitus;
- •Pulsatile tinnitus;
- •Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians(Menière's disease, temporomandibular joint disorder or other diseases);
- •Had evidence of conductive hearing loss (confirmed by abnormal otoscopy or tympanogram);
- •Had contraindications for acupuncture, including curent pregnant, severe anemia, coagulation disorders, etc;
- •Having difficulties in expressing their symptoms clearly( severe mental disorders or cognitive impairment);
- •Currently suffering from other serious acute or chronic organic diseases, such as cerebrovascular, cardiovascular, liver, kidney, hematological diseases, infectious diseases, or malignant tumors;
- •Has received intratympanic injection, postauricular injection, corticosteroids, or other medications for tinnitus treatment (includingTraditional Chinese Medicine or proprietary Chinese medicines) within the past 2 weeks or at baseline;
- •Participated in other clinical trials, particularly those closely related to tinnitus treatment, such as sound therapy;
- •have a strong desire for medication treatment.
研究者
Dan Bing
Associate Professor
Tongji Hospital