NCT07468318Not yet recruiting
Multimodal Therapy for Somatosensory Tinnitus
Multimodal Therapeutic Approach to Tinnitus Treatment With Focus on Somatosensory Components: A Randomised Controlled Trial Integrating Physiotherapy, Structured Exercise Program, and Psychological Intervention
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Migraine
- NCT number
- NCT07468318
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 1 Jan 2027 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to manual therapy:
- Recent cervical spine surgery (\<6 months)
- Ongoing physiotherapy or manual therapy for temporomandibular joint or cervical spine (\<3 months prior to enrollment)
Other illness
- Meniere's disease with recent vertigo attacks (\<3 months)
- Neurological disease affecting brainstem or auditory pathways:
- Stroke affecting auditory pathways
- Epilepsy or active seizure disorder
- Down syndrome
- Vertebrobasilar insufficiency
- Psychiatric Exclusions:
- Severe psychiatric disorder:
- Active substance abuse disorder
Other
- Audiological/ENT Exclusions:
- Objective or pulsatile tinnitus
- Active ear pathology requiring treatment:
- Acute otitis media or externa
- Chronic suppurative otitis media
- Cholesteatoma
- Suspected retrocochlear pathology:
- Acoustic neuroma (vestibular schwannoma)
- Cerebellopontine angle tumor
- Neurological Exclusions:
- Multiple sclerosis with brainstem involvement
- Brain tumor
- Musculoskeletal Exclusions:
- Severe cervical spine instability
- Rheumatoid arthritis with atlantoaxial instability
- Severe osteoporosis with fracture risk
- Recent head or neck trauma (\<3 months)
- Active psychosis
- Severe depression requiring inpatient treatment
- Acute suicidal ideation (PHQ-9 item 9 score ≥2)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charles University Faculty of physical education and sport Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.