Multimodal Therapy for Somatosensory Tinnitus

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

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.

Sponsors & Collaborators

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

  collaborator UNKNOWN

• University Hospital Regensburg, Tinnituszentrum Regensburg, Germany

  collaborator UNKNOWN

• AKESO Clinic, Prague, Czech Republic

  collaborator UNKNOWN

• Charles University, Czech Republic

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2030-06-30

Completion

2030-12-31

Countries

• Czechia

Study Locations