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
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