Manual Acupuncture for Acute Primary Tinnitus

Официальное название

Manual Acupuncture Versus Sham Acupuncture and Usual Care for Acute Primary Tinnitus: Multicentre, Randomized Clinical Trial

Обзор

This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Поведенческое Usaual care
  Health education and standard evaluation related to tinnitus

Первичные конечные точки

• Tinnitus Handicap Inventory (THI, 0-100) [Срок оценки: 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) [Срок оценки: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.]

Вторичные конечные точки (12)

• Effective response rate of THI [Срок оценки: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.]
• Effective response rate of TFI. [Срок оценки: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.]
• Visual Analogue Scale (VAS) for aural fullness [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.]
• Adverse Events [Срок оценки: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)]
• Assessment of blinding [Срок оценки: At 12 weeks after randomization]
• Acupuncture expectancy scale(AES) [Срок оценки: Baseline visit, and end of treatment at 4 weeks after randomization,.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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 · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Ухань

Идентификаторы

NCT: NCT07515482 · Tinnitus(2025-TJ-MA)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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