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.
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)
Objective or pulsatile tinnitus
Acute otitis media or externa
Chronic suppurative otitis media
Cholesteatoma
Crossover
Multimodal physiotherapy for TMJ and Cervical spine
Other interventionManual therapy (mobilisations of TMJ and cervical spine C0-C7, myofascial techniques, intraoral TMJ techniques with gloves), neuromuscular exercise (CCFT with pressure biofeedback, scapular stabilisation, proprioceptive training), home exercise program. 16 sessions × 60 min over 8 weeks. Arms: Arm 1.
Combined Exercise Program (Aerobic + Resistance + Breathing)
BehavioralStructured 8-week combined exercise program: aerobic training (60-85% HRmax), progressive resistance training (40-80% 1RM), breathing and relaxation exercises (diaphragmatic breathing, box breathing, resonant breathing). 24 sessions × 60 min; 1× supervised/week + 2× home-based/week. Strict instructions to avoid the Valsalva manoeuvre. Arms: Arm 1.
Tinnitus-Specific Psychological Support
BehavioralOne group psychoeducation session (90 min): vicious cycle model of tinnitus distress, cognitive restructuring, attention regulation training, relaxation technique. Weekly self-help materials (worksheets, audio recordings, mindfulness). On-demand individual psychological support (max. 3 sessions per 8 weeks). Arms: Arm 1.
Change in Tinnitus Handicap Inventory (THI) score
The primary outcome is the change in tinnitus-related handicap measured by the Tinnitus Handicap Inventory (THI). The THI is a 25-item self-report questionnaire assessing the functional, emotional, and catastrophic impact of tinnitus on daily life. Total scores range from 0 to 100, where higher scores indicate greater tinnitus-related handicap. The primary analysis will compare the change in THI score from baseline between the multimodal intervention group and the control group.
Change in tinnitus loudness assessed by Visual Analogue Scale (VAS)
Change in perceived tinnitus loudness measured by the Visual Analogue Scale (VAS). The VAS is a single-item self-report scale ranging from 0 to 10, where 0 indicates no tinnitus loudness and 10 indicates the worst imaginable tinnitus loudness.
Change in quality of life assessed by the Short Form Health Survey (SF-36)
Change in health-related quality of life measured by the Short Form Health Survey (SF-36). The SF-36 is a 36-item self-report questionnaire assessing 8 domains of health-related quality of life. Scores range from 0 to 100 for each domain, where higher scores indicate better quality of life.
Change in cervical range of motion assessed by goniometry
Change in active cervical range of motion measured by goniometry. Cervical range of motion will be assessed in all planes: flexion, extension, lateral flexion (left/right), and rotation (left/right). The unit of measure is degrees (°). Higher values indicate greater cervical mobility.
Change in well-being assessed by the World Health Organization Five Well-Being Index (WHO-5)
Change in subjective well-being measured by the World Health Organization Five Well-Being Index (WHO-5). The WHO-5 is a 5-item self-report questionnaire. Scores range from 0 to 25, where higher scores indicate better well-being.
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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
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