Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

Study Overview
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Brief Summary
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TMD treatment, based on state of the art knowledge derived from clinical studies will be applied in patients with tinnitus and TMD. When this approach proves to be useful for the treatment of tinnitus, it offers a new therapeutic option for patients with tinnitus. To understand how TMD treatment works for patients with tinnitus, we will analyse mediating factors, i.e. factors that contribute to the therapeutic effect. To help clinicians in their clinical process we will identify prognostic indicators, i.e. factors that predict a positive or negative outcome of TMD treatment. This can provide a helpful tool in clinical practice.

Official Title
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The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Other: TMD treatment: physiotherapy and/or occlusal splints


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included when suffering from somatic tinnitus, attributed to TMD, which has been stable for at least 3 months. Tinnitus Functional Index score between 25 and 90 Exclusion Criteria: clear otological or neurological causes of the tinnitus such as Menière's disease, severe depression (diagnosed by a psychologist), progressive middle ear pathology, intracranial pathology traumatic cervical spine or temporomandibular injury in the past 6 months tumours previous surgery in the orofacial area in case physical therapy treatment directed to the orofacial area is contra-indicated if the patient received TMD treatment in the past 2 months drug intake that can affect the outcome measures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One study arm will be treated immediately after inclusion. The other study arm will be treated after a delay of 9 weeks. During these 9 weeks patients will be on a waiting list.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct treatment<br>Patients receive the TMD treatment immediately | Other: TMD treatment: physiotherapy and/or occlusal splints<br>* The patient will receive the most appropriate TMD treatment, based on current literature.<br>|
| Experimental: Delayed treatment<br>No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group | Other: TMD treatment: physiotherapy and/or occlusal splints<br>* The patient will receive the most appropriate TMD treatment, based on current literature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Questionnaire | Questionnaire to measure the change in tinnitus related distress | Baseline, 9 weeks, 18 weeks, 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index | Questionnaire to measure the change in tinnitus severity | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Hyperacusis Questionnaire | Questionnaire to measure the presence of hyperacusis | Baseline | 
| Visual analogue scale for tinnitus loudness | Scale to measure the change in average tinnitus loudness | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| TMD pain screener | Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Hospital anxiety and depression scale | Questionnaire to measure the presence of anxiety and/or depression | Baseline | 
| Specific anamnestic questions | pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,... | Baseline | 
| Static investigation of the temporomandibular joint | evaluation of change in isometric contraction of jaw muscles | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Dynamic investigation of the temporomandibular joint | evaluation of change in isotonic contraction of jaw muscles | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Pain pressure threshold | measurement of change in pain pressure thresholds on masseter, temporalis, temporomandibular joint, sternocleidomastoideus, tibialis anterior | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Mouth opening | change in mouth opening measured in cm with a ruler | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Pain on palpation of masseter, temporalis and temporomandibular joint | change in recognisable pain on palpation, measured on numerical rating scale | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Tinnitus Analysis | analysis of the tinnitus type, pitch and loudness | Baseline | 
| Speech in noise test | analysis of the change in understanding spoken words in a noisy situation | Baseline, 9 weeks, 18 weeks, 27 weeks | 
| Pure tone audiometry | evaluation of possible hearing problems | Baseline | 
| Auditory evoked potentials measurement | change in EEG during listening tasks | Baseline, 18 weeks |