An interventional study of Multimodal physiotherapy for TMJ and Cervical spine and Combined Exercise Program (Aerobic + Resistance + Breathing) in Ear Noise, Tinnitus, Noise Induced and Tinnitus, Subjective, sponsored by Charles University, Czech Republic. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Treatment
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.
Background: Somatosensory tinnitus represents a clinically significant subgroup in which tinnitus is modulated by somatic manoeuvres (jaw movements, cervical rotation, trigger point palpation). The neuroanatomical basis involves convergence of somatosensory afferents from the TMJ and upper cervical spine (C1-C3) in the medullary nucleus spinalis nervi trigemini, with excitatory projections to the dorsal cochlear nucleus (DCN), leading to disinhibition of spontaneous neural activity perceived as tinnitus (Da Silva et al., 2023). Despite this evidence, multimodal treatment protocols specifically targeting somatosensory tinnitus remain largely absent from clinical practice in the Czech Republic.
Study Design: Single-centre randomized controlled trial with longitudinal follow-up and a crossover substudy on acute exercise effects. Stratified randomization by age group (18-35 / 36-50 / 51-70 years) and sex. Rotating block system: 4 blocks of \~27 participants; 8 weeks active intervention + 8 weeks pause per block.
Intervention: 8-week multimodal program comprising: (A) Physiotherapy - 16 sessions × 60 min: manual therapy of TMJ and cervical spine (myofascial techniques including intraoral TMJ techniques), neuromuscular exercise, proprioceptive training, home exercise program; (B) Exercise Program - 24 sessions × 60 min: combined aerobic (60-85% HRmax), resistance (40-80% 1RM), and breathing/relaxation training; 1× supervised/week + 2× home-based/week; (C) Psychological Support - 1× group psychoeducation session (90 min): cognitive-behavioral model of tinnitus distress, attention regulation, relaxation; weekly self-help materials; on-demand psychological support (max. 3× per 8 weeks).
Crossover Substudy: Repeated measures crossover design examining acute effects of 5 standardized conditions (low/high intensity aerobic exercise; low/high intensity resistance exercise; control rest) on tinnitus perception (VAS loudness and distress), with ≥48-72h washout between conditions.
Questionnaire Validation: Psychometric validation of Czech versions of THI, TFI, TCS, MTQ, CRF, TSCHQ, MDI, and WB questionnaires according to COSMIN guidelines, including reliability, validity, responsiveness, and MID determination.
Outcomes: Primary: THI change from baseline to 3, 12, and 24 months. Secondary: TFI, VAS/NRS, CGI, GAD-7, PHQ-9, PSQI, SF-36, WHO-5, cervical ROM, TMJ function (JFLS-20), NDI, CPET parameters (VO₂peak), body composition (BIA), muscle strength, autonomic regulation (BP, HR, PWV), and EEG spectral analysis (exploratory).
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Charles University, Czech Republic is the lead sponsor of 228 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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
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
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
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.
Time frame: Baseline, 4 weeks, 8 weeks (end of intervention), 3 months, 12 months, and 24 months.
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.
Time frame: Baseline, 8 weeks, 3 months, 12 months, 24 months
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.
Time frame: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months
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.
Time frame: 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)
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.
Time frame: 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)
Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report questionnaire. Scores range from 0 to 21, where higher scores indicate more severe anxiety symptoms.
Time frame: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.
Change in depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9)
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire. Scores range from 0 to 27, where higher scores indicate more severe depressive symptoms.
Time frame: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item self-report questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.
Change in temporomandibular joint range of motion assessed by direct measurement
Change in temporomandibular joint (TMJ) range of motion measured by direct millimeter measurement using a ruler/caliper. Assessed parameters include maximum mouth opening, lateral mandibular movements (left/right), and protrusion. The unit of measure is millimeters (mm). Higher values indicate greater TMJ mobility.
Time frame: Baseline, 8 weeks, 3 months, 12 months, 24 months.
Change in cervical muscle tone assessed by algometry (pressure pain threshold)
Change in cervical muscle tone measured by pressure algometry. Pressure pain threshold (PPT) will be assessed bilaterally at standardized trigger point locations in the cervical and craniocervical region (m. trapezius, m. sternocleidomastoideus, suboccipital muscles, m. levator scapulae). The unit of measure is kilopascals (kPa) or kilograms per square centimeter (kg/cm²). Higher values indicate lower muscle tenderness and better muscle tone.
Time frame: Baseline, 8 weeks, 3 months, 12 months, 24 months.
Plan to share: No
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