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《手法针刺治疗急性原发性耳鸣疗效：一项多中心随机对照临床试验》

2026年6月10日 更新者：Dan Bing

手动针刺治疗急性原发性耳鸣

这项多中心临床试验旨在研究手动针刺对急性原发性耳鸣的疗效和安全性。

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

这是一项多中心随机、单盲、假针刺对照试验。 总试验周期为14周，包括两周基线评估、随机化后四周治疗期和八周随访期。 随机化前将从每位患者处获取知情同意。 基线评估后，独立研究者将以1:1:1的比例将符合条件患者随机分配至接受手法针刺、假针刺或常规治疗组。 所有患者将在四周治疗期内接受10次每次30分钟的针刺治疗或常规治疗。 患者将每周接受三次治疗以完成两周初始疗程，随后每周接受两次治疗以完成两周巩固疗程。 在手法针刺组和假针刺组中，针刺治疗将在随机化后立即开始。 在常规治疗组中，患者将在等待12周后免费接受针刺治疗。

研究类型

介入性

注册 (估计的)

180

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Hubei
      • Wuhan、Hubei、中国、430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  1. 年龄在18至65岁之间（性别不限）；
  2. 主要主诉为耳鸣；
  3. 符合原发性耳鸣的诊断标准；
  4. 耳鸣应具有困扰性，THI评分在28至76分之间，且持续时间≥2周；
  5. 耳鸣持续时间少于6个月；
  6. 过去3个月内无针灸经历；
  7. 治疗前2周内未使用任何耳鸣相关药物，包括鼓室内注射、耳后注射、皮质类固醇、中药或中成药等；
  8. 同意签署知情同意书。

排除标准：

  1. 客观性耳鸣；
  2. 搏动性耳鸣；
  3. 经听力学家和临床医生评估诊断为继发性耳鸣；
  4. 合并传导性听力损失（通过耳镜检查异常或鼓室图异常确认）；
  5. 存在针灸禁忌症，包括孕妇、严重贫血、凝血功能障碍等；
  6. 难以清晰表达症状，如严重精神障碍或认知障碍；
  7. 目前患有其他严重急性或慢性器质性疾病，如脑血管、心血管、肝脏、肾脏、血液系统疾病、传染病或恶性肿瘤；
  8. 参加过其他临床试验，特别是与耳鸣治疗密切相关的试验，如声音疗法；
  9. 有强烈的药物治疗意愿。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Manual acupuncture group
Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period.
行为的：常规护理
耳鸣相关的健康教育和标准评估
其他：Manual acupuncture
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the remaining weeks.
假比较器：Sham acupuncture
Ten sessions of 30 minute sham acupuncture are deivered during 4 weeks.
行为的：常规护理
耳鸣相关的健康教育和标准评估
其他：Sham acupuncture
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the last 2 weeks.
其他：Usual care
Health education and guidance related to tinnitus
行为的：常规护理
耳鸣相关的健康教育和标准评估

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Tinnitus Handicap Inventory (THI, 0-100)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap. In details, 0-16 points indicate no handicap; 18-36 points indicate mild handicap;38-56 points indicate moderate handicap; 58-76 points indicate severe handicap and >76 points indicate catastrophic handicap.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Tinnitus Functional Index (TFI, 0-100)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

次要结果测量

结果测量
措施说明
大体时间
Effective response rate of THI
大体时间：End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points.
End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of TFI.
大体时间：End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points.
End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for aural fullness
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for tinnitus
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The pittsburgh Sleep Qual-ityIndex (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has 19 questions which can be grouped into seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep dis-turbances, use of sleeping medication, and daytime dysfunction.The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Depression Scale(SDS)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Anxiety Scale(SAS)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
World Health Organization Quality of Life-BREF questionnaire(WHOQOL-BREF)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), yielding domain scores and an overall score (0-100; higher scores indicate better quality of life).
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9)
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Adverse Events
大体时间：Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Adverse events assessed each acupuncture treatment visit using a acupuncture adverse events questionnaire recording presence and severity of side effects (e.g., subcutaneous hemorrhage, minor bleeding) related to acupuncture, plus event frequency.
Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Assessment of blinding
大体时间：At 12 weeks after randomization
At the end of the study, we will determine the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin.
At 12 weeks after randomization
Acupuncture expectancy scale(AES)
大体时间：Baseline visit, and end of treatment at 4 weeks after randomization,.
The Acupuncture Expectancy Scale (AES) will be completed by participants in the verum and sham acupuncture groups at baseline and at the end of treatment (4 weeks after randomization). The questionnaire will not be administered to the usual care group.
Baseline visit, and end of treatment at 4 weeks after randomization,.
Massachusetts General Hospital Acupuncture Sensation Scale(MASS)
大体时间：Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
The Massachusetts General Hospital Acupuncture Sensation Scale, which includes twelve specific descriptors-soreness, aching, deep pressure, heaviness, fullness or distension, tingling, numbness, sharp pain, dull pain, warmth, cold, and throbbing-as well as an open field for patients to describe the sensation in their own words, will be administered following a brief explanation of de qi sensations by the acupuncturist to participants in the verum acupuncture and sham acupuncture groups, while the usual care group will not receive this questionnaire.
Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Auditory Sensitivity Scale
大体时间：Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Auditory Sensitivity Scale is a self-report questionnaire consisting of general questions on tinnitus and sound intolerance, along with 25 items rated on different scoring scales (e.g., 0/2/5, 0/1/2, 0/10), and provides a severity classification based on the total score: 31-55 for mild, 56-80 for moderate, 81-100 for severe, and 101-126 for very severe.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

其他结果措施

结果测量
措施说明
大体时间
10-item short version of the Big Five Inventory (BFI-10)
大体时间：Baseline visit(before randomization)
Personality is assessed by a10-item short version of the Big Five Inventory (BFI-10).
Baseline visit(before randomization)
Pure-Tone Audiometry(PTA)
大体时间：Baseline visit(before randomization)
Pure tone audiometry is conducted under standard soundproof conditions using the Hughson-Westlake method to obtain the air conduction threshold (bone conduction threshold is only used for diagnosis, to determine whether there is conductive hearing loss, and to assist in the screening process; statistical analysis only uses the air conduction threshold). The standard test frequencies range from 0.25 to 8 kHz. If conditions permit, extended high frequencies (Extended High Frequency, EHF; ≥ 9-16 kHz) are added, and necessary masking is performed in accordance with the norms.
Baseline visit(before randomization)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Dan Bing

合作者

Taihe Hospital
Wuhan No.1 Hospital
The Third People's Hospital of Hubei Province
Hubei Xinhua Hospital
Qianjiang Central Hospital

调查人员

  • 首席研究员：Dan Bing, PhD、Tongji Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月15日

初级完成 (估计的)

2027年10月30日

研究完成 (估计的)

2027年12月12日

研究注册日期

首次提交

2026年3月31日

首先提交符合 QC 标准的

2026年3月31日

首次发布 (实际的)

2026年4月7日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Tinnitus(2025-TJ-MA)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

去标识化后的个人参与者数据可根据个别请求与主要研究者共享，联系邮箱：didibing1981@aliyun.com

IPD 共享时间框架

IPD和支持信息将在结果发表后2年内提供。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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