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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tinnitus; Neural Therapy of Huneke
• Intervention / Treatment: Procedure: Neural Therapy of Huneke; Drug: Betahistine 24 mg bid (Betaserc)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jülide Öncü Alptekin, Professor Doctor, MD; Phone Number: +90507 231 6817; Email: julideoncu@yahoo.com
• Study Contact Backup: Name: Roza Jizel Dağdelen, MD; Phone Number: +90 212 373 50 00; Email: rozadagdelen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Drug: Betahistine 24 mg bid (Betaserc); Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.
Experimental: Treatment Group	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Turkish version of the Tinnitus Disability Questionnaire (THI)	3 months
SF-12 (short form)	3 months
Tinnitus severity according to VAS (visual analog scale)	3 months

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 26, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Tinnitus; Neural Therapy of Huneke
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Betahistine; BID protein, human; Anesthesia, Local
• Other Study ID Numbers: 16.02.2021 / 3158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 6 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No