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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSisli Hamidiye Etfal Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients with a disease that may cause objective tinnitus,

Otosclerosis,

Chronic otitis media,

Acoustic tumor,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neural Therapy of Huneke

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Turkish version of the Tinnitus Disability Questionnaire (THI)

Time frame
3 months
2

SF-12 (short form)

Time frame
3 months
3

Tinnitus severity according to VAS (visual analog scale)

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: