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NCT07468318

Multimodal Therapy for Somatosensory Tinnitus

Sponsor: Charles University, Czech Republic

View on ClinicalTrials.gov

Summary

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.

Official title: Multimodal Therapeutic Approach to Tinnitus Treatment With Focus on Somatosensory Components: A Randomised Controlled Trial Integrating Physiotherapy, Structured Exercise Program, and Psychological Intervention

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2027-01-01

Completion Date

2030-12-31

Last Updated

2026-03-12

Healthy Volunteers

Yes

Conditions

Ear Noise Tinnitus, Noise Induced Tinnitus, Subjective Headache Other Temporomandibular Dysfunction Cervical Migraine Syndrome Chronic Tinnitus

Interventions

OTHER

Multimodal physiotherapy for TMJ and Cervical spine

Manual 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.

BEHAVIORAL

Combined Exercise Program (Aerobic + Resistance + Breathing)

Structured 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.

BEHAVIORAL

Tinnitus-Specific Psychological Support

One 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.

Inclusion Criteria: * 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) * Positive somatosensory modulation test: ability to reproducibly modulate tinnitus (change in loudness, pitch, or quality) through at least one of the following manoeuvres: * Jaw movements (mouth opening, lateral excursion, protrusion, clenching) * Neck movements (flexion, extension, rotation, lateral flexion) * Pressure on specific head/neck muscles * Eye movements or shoulder elevation * Willing and able to attend all study sessions over 28 weeks * Adequate cognitive capacity to understand study procedures and complete questionnaires in the Czech language * Signed written informed consent Exclusion Criteria: * Audiological/ENT Exclusions: * Objective or pulsatile tinnitus * Active ear pathology requiring treatment: * Acute otitis media or externa * Chronic suppurative otitis media * Cholesteatoma * Meniere's disease with recent vertigo attacks (\<3 months) * Suspected retrocochlear pathology: * Acoustic neuroma (vestibular schwannoma) * Cerebellopontine angle tumor * Neurological Exclusions: * Neurological disease affecting brainstem or auditory pathways: * Multiple sclerosis with brainstem involvement * Stroke affecting auditory pathways * Brain tumor * Epilepsy or active seizure disorder * Musculoskeletal Exclusions: * Contraindications to manual therapy: * Severe cervical spine instability * Rheumatoid arthritis with atlantoaxial instability * Down syndrome * Vertebrobasilar insufficiency * Severe osteoporosis with fracture risk * Recent cervical spine surgery (\<6 months) * Recent head or neck trauma (\<3 months) * Ongoing physiotherapy or manual therapy for temporomandibular joint or cervical spine (\<3 months prior to enrollment) * Psychiatric Exclusions: * Severe psychiatric disorder: * Active psychosis * Severe depression requiring inpatient treatment * Acute suicidal ideation (PHQ-9 item 9 score ≥2) * Active substance abuse disorder * Other Exclusions: * Pregnancy (due to modifications needed in physical examination and treatment) * Ongoing litigation or compensation claims related to tinnitus or hearing loss * Current participation in another interventional clinical trial * Expected change of residence or long-term absence (\>2 weeks) during the study period * Unable or unwilling to comply with study procedures and attend all sessions

Locations (1)

Charles University Faculty of physical education and sport

Prague, Czechia