Combined Physiotherapy, Exercise and Psychological Support for Jaw and Neck Related Tinnitus
Tests physiotherapy, exercise and counselling in adults with ringing ears linked to jaw problems.
Key facts
- Who runs it
- Charles University, Czech Republic
- Where
- Prague, CzechiaSee the site
- Trial code
- Registry title
- Multimodal Therapy for Somatosensory Tinnitus
- Status
- Not yet recruiting
- People taking part
- 160 people, planned
- Starts
- 1 Jan 2027
- Expected to end
- 31 Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Multimodal physiotherapy for TMJ and Cervical spine
- Combined Exercise Program (Aerobic + Resistance + Breathing)
- Tinnitus-Specific Psychological Support
- Record updated
- 12 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting ringing or buzzing in the ears that changes when they move the jaw or neck.
- Age
- 18 to 70 years (inclusive)
- Sex
- All sexes can join.
- Disease stage
- Chronic subjective tinnitus for at least 6 months, with a Tinnitus Handicap Inventory (THI) score of 18 or more. The tinnitus must change in loudness, pitch or quality with jaw, neck, muscle-pressure, eye or shoulder movements.
- Earlier treatment
- People who had physiotherapy or manual therapy for the jaw joint or neck in the last 3 months cannot join.
Main reasons for not taking part
- Pulsatile tinnitus or active ear disease needing treatment
- Suspected tumour or other problem of the hearing nerve pathway
- Neurological disease affecting the brainstem or hearing pathways, or epilepsy
- Conditions that rule out manual therapy, such as Down syndrome or severe neck instability
- Pregnancy, severe psychiatric disorder, or taking part in another interventional trial
The registry criteria, word for word
Show all 49 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Czechia
- Charles University Faculty of physical education and sportPrague, CzechiaContact: Jitka Malá, PhDr. PhD.Not yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Multimodal Interventional GroupTreatment being tested
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.
Treatment: Multimodal physiotherapy for TMJ and Cervical spine, Combined Exercise Program (Aerobic + Resistance + Breathing), and Tinnitus-Specific Psychological Support
- Control GroupNo study treatment, for comparison
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).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multimodal Therapeutic Approach to Tinnitus Treatment With Focus on Somatosensory Components: A Randomised Controlled Trial Integrating Physiotherapy, Structured Exercise Program, and Psychological Intervention
- Plain-language title
- Combined Physiotherapy, Exercise and Psychological Support for Jaw and Neck Related TinnitusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07468318, who can take part
- Record updated
- 12 March 2026