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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07334002
Enrollment
30
Registered
2026-01-12
Start date
2026-03-01
Completion date
2026-05-26
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neural Therapy of Huneke, Tinnitus

Keywords

Neural Therapy of Huneke, Tinnitus

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.

Interventions

PROCEDURENeural 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.

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

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Contacts

CONTACTRoza Jizel Dağdelen, MD
rozadagdelen@gmail.com+90 212 373 50 00
CONTACTJülide Öncü Alptekin, Professor Doctor, MD
julideoncu@yahoo.com+90507 231 6817

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026