Acupuncture Versus Sham Acupuncture for Tinnitus

Официальное название

Efficacy and Safety of Acupuncture Versus Sham Acupuncture in the Treatment of Tinnitus: A Randomized Controlled Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Acupuncture
  Standardized acupuncture treatment will be administered 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 inserted according to standardized acupoint locations and retained for 20 minutes. Participants will also receive tinnitus-related health education.
• Процедура Sham Acupuncture
  Non-penetrating sham acupuncture will be administered 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.

Первичные конечные точки

• Change in Tinnitus Handicap Inventory Score From Baseline to Week 5 [Срок оценки: Baseline and Week 5]

Вторичные конечные точки (9)

• Change in Pittsburgh Sleep Quality Index Score [Срок оценки: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17]
• Change in Tinnitus Loudness Visual Analog Scale Score [Срок оценки: 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 [Срок оценки: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17]
• Change in Self-Rating Anxiety Scale Score [Срок оценки: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17]
• Change in Self-Rating Depression Scale Score [Срок оценки: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17]
• Change in Pure Tone Audiometry Thresholds [Срок оценки: Baseline ,week1, Week 5]
• Change in Tinnitus Matching Loudness [Срок оценки: Baseline ,week1, Week 5]
• Change in Distortion Product Otoacoustic Emissions [Срок оценки: Baseline ,week1, Week 5]
• Incidence of Adverse Events [Срок оценки: From baseline through Week 17]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University — Шанхай
• Longhua Hospital, Shanghai University of Traditional Chinese Medicine — Шанхай
• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Universi — Шанхай

Идентификаторы

NCT: NCT07700069 · SH9H-2026-T202-1 · 2025CROC07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗