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SOMATINMultimodal Treatment for Somatosensory Tinnitus: Physiotherapy, Exercise, and Psychological Intervention

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Study Aim

This study aims to evaluate the effectiveness of a multimodal treatment, combining physiotherapy, exercise, and psychological intervention, in reducing the impact of tinnitus on your daily life, as measured by the Tinnitus Handicap Inventory (THI) score.

What is being tested

Multimodal physiotherapy for TMJ and Cervical spine

+ Combined Exercise Program (Aerobic + Resistance + Breathing)

+ Tinnitus-Specific Psychological Support

OtherBehavioral
Who is being recruted

Brain Diseases+19

+ Central Nervous System Diseases

+ Ear Diseases

From 18 to 70 Years
+49 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2027
See protocol details

Summary

Principal SponsorCharles University, Czech Republic
Study ContactJitka Malá, PhDr. Ph.D.
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2027

Actual date on which the first participant was enrolled.

This study focuses on a specific type of tinnitus, known as somatosensory tinnitus, where the ringing in the ears is influenced by movements like jaw clenching, neck rotation, or trigger point pressure. The aim is to explore a multimodal treatment approach that combines physiotherapy, a structured exercise program, and psychological intervention. This research is important as it addresses a gap in clinical practice in the Czech Republic, despite evidence suggesting the effectiveness of such multimodal approaches for this condition. The study involves a single-centre randomized controlled trial with a longitudinal follow-up and a crossover substudy. Participants will engage in an 8-week program that includes physiotherapy sessions, a supervised and home-based exercise program, and psychological support. The physiotherapy involves manual therapy of the jaw and neck, while the exercise program combines aerobic, resistance, and relaxation training. The psychological support includes a group psychoeducation session, weekly self-help materials, and on-demand psychological support. The primary outcome measured is the change in tinnitus-related handicap using the Tinnitus Handicap Inventory (THI) score from baseline to 3, 12, and 24 months.

Official TitleMultimodal Therapeutic Approach to Tinnitus Treatment With Focus on Somatosensory Components: A Randomised Controlled Trial Integrating Physiotherapy, Structured Exercise Program, and Psychological Intervention
Principal SponsorCharles University, Czech Republic
Study ContactJitka Malá, PhDr. Ph.D.
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesEar DiseasesHearing DisordersJaw DiseasesJoint DiseasesMandibular DiseasesMigraine DisordersStomatognathic DiseasesMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsTemporomandibular Joint DisordersTinnitusCraniomandibular DisordersHeadache DisordersHeadache Disorders, Primary

Criteria

11 inclusion criteria required to participate
Signed written informed consent

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)

Show More Criteria

38 exclusion criteria prevent from participating
Neurological disease affecting brainstem or auditory pathways

Multiple sclerosis with brainstem involvement

Stroke affecting auditory pathways

Brain tumor

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Charles University Faculty of physical education and sport

Prague, CzechiaOpen Charles University Faculty of physical education and sport in Google Maps
Recruiting soonOne Study Center
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