比较透刺与认知行为疗法治疗主观性耳鸣的随机对照试验研究方案
Study protocol for a randomized controlled trial comparing penetrating needling and cognitive behavioral therapy for subjective tinnitus.
文献信息
| PMID | 42827440 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Shasha Yang |
| 作者单位 | Department of Otolaryngology, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, Guizhou, China. |
| 期刊 | Frontiers in neurology |
| SCI 分区 | Q2 |
| IF | 3.5 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 描述一项随机对照试验的研究方案，该试验旨在评估透刺与认知行为疗法（CBT）相比在主观性耳鸣患者中的临床疗效。
方法： 本方案描述了一项拟开展的评估者与分析者盲法、平行组随机对照试验。共72名参与者将按1：1随机分配至接受透刺加健康教育的治疗组或接受CBT加健康教育的对照组。透刺将每周进行5次，连续2周（共10次）。主要结局指标为耳鸣残疾量表（THI）、耳鸣问卷（TQ）和耳鸣响度视觉模拟量表（VAS）。次要结局指标包括匹兹堡睡眠质量指数（PSQI）、汉密尔顿抑郁量表（HAMD）和汉密尔顿焦虑量表（HAMA）。结局将在基线、治疗1周后、治疗2周后以及4周随访时（通过电话、在线或门诊）进行评估。
结论： 由于CBT是已确立的标准治疗，本拟开展的平行组试验旨在专门评估透刺的疗效。本方案的研究结果有望提供严谨、高质量的证据，以确定透刺作为主观性耳鸣神经调控替代疗法的可行性。
临床试验注册： http://itmctr.ccebtcm.org.cn/，ITMCTR2024000264。
英文摘要
OBJECTIVE: To describe the protocol for a randomized controlled trial designed to evaluate the clinical efficacy of penetrating needling compared with cognitive behavioral therapy (CBT) in patients with subjective tinnitus.
METHODS: This protocol describes a proposed assessor- and analyst-blinded, parallel-group randomized controlled trial. A total of 72 participants will be randomized 1:1 to a treatment group receiving penetrating needling plus health education or a control group receiving CBT plus health education. Penetrating needling will be administered five times weekly for two consecutive weeks (10 sessions). The primary outcomes are the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), and a Visual Analogue Scale (VAS) for tinnitus loudness. Secondary outcomes include the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Depression Scale (HAMD), and the Hamilton Anxiety Scale (HAMA). Outcomes will be assessed at baseline, after one week of treatment, after two weeks of treatment, and at a 4-week follow-up (by telephone, online, or in clinic).
CONCLUSION: As CBT is an established standard of care, this proposed parallel-group trial is designed to specifically evaluate the efficacy of penetrating needling. The findings of this protocol are expected to provide rigorous, high-quality evidence to determine the viability of penetrating needling as a neuromodulatory alternative for subjective tinnitus.
CLINICAL TRIAL REGISTRATION: http://itmctr.ccebtcm.org.cn/, ITMCTR2024000264.