Efficacy and Safety of Acupuncture Versus Sham Acupuncture in the Treatment of Tinnitus: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
- 试验地点
- 3
- 主要终点
- Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
研究概览
简要总结
This multicenter, randomized, sham-controlled clinical trial will evaluate the efficacy and safety of acupuncture for patients with subjective idiopathic tinnitus. A total of 226 eligible participants will be randomly assigned to receive either acupuncture or sham acupuncture. Both groups will receive treatment for 5 weeks. The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus loudness, tinnitus severity, sleep quality, anxiety, depression, audiological assessments, and adverse events. Exploratory neuroimaging outcomes include functional magnetic resonance imaging and magnetoencephalography measures.
详细描述
Subjective idiopathic tinnitus is a common otologic condition that may be associated with sleep disturbance, anxiety, depression, and reduced quality of life. Current treatment options often provide limited symptom relief, and high-quality evidence for acupuncture in tinnitus remains insufficient.
This study is designed as a multicenter, randomized, sham-controlled clinical trial to compare acupuncture with non-penetrating sham acupuncture in patients with chronic subjective idiopathic tinnitus. Eligible participants will be adults aged 18 to 80 years with tinnitus as the primary complaint, tinnitus duration of at least 6 months, and a baseline Tinnitus Handicap Inventory score of 38 or higher.
Participants will be randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group. The acupuncture group will receive standardized acupuncture treatment based on the therapeutic principle of invigorating the spleen, tonifying the kidney, and opening the orifices. The sham acupuncture group will receive non-penetrating sham acupuncture at the same acupoints. Both groups will receive treatment for 5 weeks and tinnitus-related health education.
Participants will be assessed at baseline, during treatment, at the end of treatment, and during post-treatment follow-up. The primary endpoint is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus-related visual analog scale scores, Pittsburgh Sleep Quality Index, Self-Rating Anxiety Scale, Self-Rating Depression Scale, pure tone audiometry, tinnitus matching, distortion product otoacoustic emissions, and adverse events. Exploratory outcomes include changes in brain functional connectivity measured by functional magnetic resonance imaging and brain power spectral density measured by magnetoencephalography.
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 and outcome assessors will be masked to group allocation. Acupuncturists cannot be masked due to the nature of the intervention. Randomization personnel will not participate in treatment, outcome assessment, or statistical analysis. Data analysts will remain blinded until the primary analysis is completed.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tinnitus as the primary complaint, meeting the diagnostic criteria for subjective idiopathic tinnitus.
- •Tinnitus duration of at least 6 months.
- •Patent external auditory canal and intact tympanic membrane.
- •Bilateral pure tone average no greater than 80 decibels hearing level (dB HL).
- •No contraindications to MRI or MEG scanning, such as claustrophobia or metallic implants.
- •Age 18 to 80 years.
- •Right-handed.
- •Baseline Tinnitus Handicap Inventory score of 38 or higher.
- •Able to understand and complete examinations, assessments, and treatment procedures under physician guidance.
- •Willing to participate and able to provide written informed consent before treatment.
排除标准
- •Inner ear or auditory nerve disorders, including sudden sensorineural hearing loss, Meniere disease, otosclerosis, or acoustic neuroma.
- •External or middle ear diseases, including otitis externa, foreign body in the external auditory canal, eczema of the external auditory canal, cerumen impaction, acute or chronic otitis media with effusion, or acute or chronic suppurative otitis media.
- •Non-otogenic tinnitus caused by acute or chronic systemic diseases involving hematologic, endocrine, renal, or other major organ systems.
- •Objective tinnitus, including myogenic, vascular, or patulous eustachian tube-related tinnitus.
- •Cognitive impairment or tinnitus caused by other neurological diseases, including stroke, epilepsy, traumatic brain injury, severe headache history, severe central ischemia, brain tumor, neurasthenia, or post-neurosurgical tinnitus.
- •Severe cardiovascular or cerebrovascular disease, intracranial space-occupying disease, tumor, or severe pulmonary, hepatic, renal, or hematopoietic disease.
- •Pregnancy or lactation.
- •Psychiatric disease, impaired consciousness, or inability to cooperate with examinations or treatment.
- •Participation in another conflicting clinical trial within 6 months before enrollment or currently participating in another conflicting clinical trial.
研究组 & 干预措施
Sham Acupuncture
Participants in this arm will receive non-penetrating sham acupuncture twice weekly for 5 consecutive weeks, with 10 sessions in total. The same acupoints as the acupuncture group will be used. Blunt-tip needles will contact the skin surface without skin penetration or manual needle manipulation. Needles will be retained for 20 minutes. Participants will also receive tinnitus-related health education.
干预措施: Sham Acupuncture (Procedure)
Acupuncture
Participants in this arm will receive standardized acupuncture treatment twice weekly for 5 consecutive weeks, with 10 sessions in total. Acupuncture will be performed at Tinghui (GB2), Shuaigu (GB8), Taixi (KI3), Taibai (SP3), Yifeng (TE17), and Zhigou (TE6). Needles will be retained for 20 minutes. Participants will also receive tinnitus-related health education.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
时间窗: Baseline and Week 5
The Tinnitus Handicap Inventory is a 25-item questionnaire used to assess tinnitus-related handicap. The total score ranges from 0 to 100, with higher scores indicating more severe tinnitus-related handicap. The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5.
次要结局
- Change in Pittsburgh Sleep Quality Index Score(Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17)
- Change in Tinnitus Loudness Visual Analog Scale Score(Baseline, immediately after the first treatment session, Week 1, Week 3, Week 5, Week 9, and Week 17)
- Change in Tinnitus Severity Visual Analog Scale Score(Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17)
- Change in Self-Rating Anxiety Scale Score(Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17)
- Change in Self-Rating Depression Scale Score(Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17)
- Change in Pure Tone Audiometry Thresholds(Baseline ,week1, Week 5)
- Change in Tinnitus Matching Loudness(Baseline ,week1, Week 5)
- Change in Distortion Product Otoacoustic Emissions(Baseline ,week1, Week 5)
- Incidence of Adverse Events(From baseline through Week 17)