The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

Официальное название

A Randomized, Single-blind, Controlled Trial to Evaluate the Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

Обзор

A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus. The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.

Подробное описание

All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.

Вмешательства

• Процедура Neural Therapy of Huneke
  The aim for tinnitus and facial pain is to regulate the trigeminal system and autonomic balance. Concentration used: Lidocaine 0.5%. The auriculotemporal, infraorbital, zygomaticotemporal, and stellate regions were targeted. Puncture applications: 0.3-0.5 mL will be administered behind the ear, around the mastoid process, behind the tragus, and in the temporomandibular region. If necessary, the stellate ganglion area can be supplemented with regulation injections. Negative aspiration and as
• Препарат Betahistine 24 mg bid (Betaserc)
  Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.

Первичные конечные точки

• Turkish version of the Tinnitus Disability Questionnaire (THI) [Срок оценки: 3 months]
• SF-12 (short form) [Срок оценки: 3 months]
• Tinnitus severity according to VAS (visual analog scale) [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).

Критерии исключения

• Patients with a disease that may cause objective tinnitus,

• Otosclerosis,
• Chronic otitis media,
• Acoustic tumor,
• Meniere's disease,
• History of ear surgery or head trauma, and those with neuropsychiatric diseases.

Also:

• Patients who have had ear surgery,
• Permanent hearing loss (total),
• Severe cardiovascular system failure, uncontrolled arrhythmia,
• Severe renal failure, or liver failure

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07334002 · 16.02.2021 / 3158

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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