Multimodal Therapy for Somatosensory Tinnitus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCharles University, Czech Republic

About this trial

Tinnitus (ringing or buzzing in the ears) affects approximately 10-15% of the adult population and significantly reduces quality of life in many patients. In a substantial proportion of cases, tinnitus is associated with dysfunction of the temporomandibular joint (TMJ) and cervical spine - this subtype is called somatosensory tinnitus.

This randomised controlled trial investigates the effectiveness of a multimodal intervention combining: (1) physiotherapy targeting TMJ and cervical spine dysfunction, (2) a structured combined exercise program (aerobic + resistance + breathing), and (3) psychological support (cognitive-behavioural psychoeducation) in patients with chronic somatosensory tinnitus.

The study also examines the acute effects of different types and intensities of physical exercise on tinnitus perception, and performs psychometric validation of Czech-language tinnitus assessment questionnaires.

Participants (N=160, aged 18-70 years) will be randomly assigned to either the multimodal intervention group (8 weeks, 5 sessions/week) or a control group. Follow-up assessments will be conducted at 3, 12, and 24 months. The primary outcome is the change in the Tinnitus Handicap Inventory (THI) score.

Eligibility criteria

Qualifiers

Age 18-70 years (inclusive)

Chronic subjective tinnitus present for ≥6 months

Tinnitus Handicap Inventory (THI) score ≥18 points (indicating at least mild tinnitus handicap)

Jaw movements (mouth opening, lateral excursion, protrusion, clenching)

Disqualifiers

Objective or pulsatile tinnitus

Acute otitis media or externa

Chronic suppurative otitis media

Cholesteatoma

Trial design

Treatments tested in this trial

  • Multimodal physiotherapy for TMJ and Cervical spine
  • Combined Exercise Program (Aerobic + Resistance + Breathing)
  • Tinnitus-Specific Psychological Support

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Charles University, Czech Republic

Lead sponsor

Neticho n.s. (Patient Organization for Tinnitus), Czech Republic

Collaborator

University Hospital Regensburg

Collaborator

AKESO Clinic, Prague, Czech Republic

Collaborator