Multimodal Therapy for Somatosensory Tinnitus

NCT07468318 | Not Yet Recruiting

• 1 other identifier: team Tinnitus
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

exercise therapy; tinnitus; multimodal therapy; subjective noise; somatosensory tinnitus; physiotherapy

Outcome Measures

Primary Outcomes (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.

  Baseline, 4 weeks, 8 weeks (end of intervention), 3 months, 12 months, and 24 months.

Secondary Outcomes (9)

• Change in tinnitus loudness assessed by Visual Analogue Scale (VAS)

  Baseline, 8 weeks, 3 months, 12 months, 24 months

• Change in quality of life assessed by the Short Form Health Survey (SF-36)

  Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months

• Change in cervical range of motion assessed by goniometry

  Baseline, 8 weeks, 3 months, 12 months, 24 months

• Change in well-being assessed by the World Health Organization Five Well-Being Index (WHO-5)

  Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.

• Change in anxiety symptoms assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7)

  Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.

Study Arms (2)

Multimodal Interventional Group

EXPERIMENTAL

8-week multimodal program: physiotherapy (16 sessions × 60 min, 2×/week) + structured exercise program (24 sessions × 60 min, 3×/week) + psychological support (1× group session 90 min + weekly self-help materials + on-demand support). Total: 5 sessions/week.

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

Control Group

NO INTERVENTION

No structured physiotherapy, exercise program, or tinnitus-specific psychological intervention. Participants continue usual care (stable pharmacological treatment permitted). Assessed at identical time points. Offered full multimodal intervention after study completion (ethical cross-over).

Interventions

Multimodal physiotherapy for TMJ and Cervical spine OTHER

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.

Also known as: physiotherapy, manual therapy

Multimodal Interventional Group

Combined Exercise Program (Aerobic + Resistance + Breathing) BEHAVIORAL

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.

Also known as: physical therapy, motion

Multimodal Interventional Group

Tinnitus-Specific Psychological Support BEHAVIORAL

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.

Also known as: psychological approach

Multimodal Interventional Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 disease affecting brainstem or auditory pathways:
• Multiple sclerosis with brainstem involvement
• Stroke affecting auditory pathways
• Brain tumor
• Epilepsy or active seizure disorder
• Contraindications to manual therapy:

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• University Hospital Regensburg, Tinnituszentrum Regensburg, Germany: collaborator
• AKESO Clinic, Prague, Czech Republic: collaborator
• Neticho n.s. (Patient Organization for Tinnitus), Czech Republic: collaborator

Study Sites (1)

Charles University Faculty of physical education and sport

Prague, Czechia

Location

MeSH Terms

Conditions

Tinnitus; Temporomandibular Joint Disorders; Migraine Disorders

Interventions

Physical Therapy Modalities; Musculoskeletal Manipulations; Respiration; Motion

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Complementary Therapies; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Physical Phenomena

Central Study Contacts

Jitka Malá, PhDr. Ph.D.

CONTACT

+420608111418; jitka.mala@ftvs.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment (RCT: intervention vs. control) + Crossover assignment

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)