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

NCT ID: NCT07334002

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-03-30

Brief Summary

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.

Detailed Description

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.

Conditions

Tinnitus; Neural Therapy of Huneke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Group

Group Type: EXPERIMENTAL

Neural Therapy of Huneke

Intervention Type: PROCEDURE

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.

Control Group

Group Type: ACTIVE_COMPARATOR

Betahistine 24 mg bid (Betaserc)

Intervention Type: DRUG

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

Interventions

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 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.

Intervention Type: PROCEDURE

Betahistine 24 mg bid (Betaserc)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Roza Jizel Dagdelen MD

Medical Doctor , Assistant Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Roza Jizel Dağdelen, MD

Role: CONTACT

rozadagdelen@gmail.com

+905388223877

Jülide Öncü Alptekin, Professor Doctor, MD

Role: CONTACT

julideoncu@yahoo.com

+90507 231 6817

Other Identifiers

16.02.2021 / 3158

Identifier Type: -

Identifier Source: org_study_id