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

N/ANot Yet RecruitingNCT07334002

Sisli Hamidiye Etfal Training and Research Hospital30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tinnitus Neural Therapy of Huneke

Interventions

Neural Therapy of HunekePROCEDURE

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 aseptic technique will be applied before each application. Transient mild dizziness or local redness may occur after application. To avoid the risk of systemic toxicity, the total dose should generally not exceed a maximum of 200 mg of lidocaine.

Betahistine 24 mg bid (Betaserc)DRUG

Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Turkish version of the Tinnitus Disability Questionnaire (THI)

Time frame: 3 months

SF-12 (short form)

Time frame: 3 months

Tinnitus severity according to VAS (visual analog scale)

Time frame: 3 months

Central Contacts

Roza Jizel Dağdelen, MD

CONTACT

+905388223877 rozadagdelen@gmail.com

Jülide Öncü Alptekin, Professor Doctor, MD

CONTACT

+90507 231 6817 julideoncu@yahoo.com

Data from ClinicalTrials.gov

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