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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
| Fonds voor Wetenschappelijk onderzoek Vlaanderen | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct treatment | Experimental | Patients receive the TMD treatment immediately |
|
| Delayed treatment | Experimental | No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMD treatment: physiotherapy and/or occlusal splints | Other | The patient will receive the most appropriate TMD treatment, based on current literature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Questionnaire | Questionnaire to measure the change in tinnitus related distress | Baseline, 9 weeks, 18 weeks, 27 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair ziekenhuis Antwerpen | Edegem | Antwerpen | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30314506 | Derived | Michiels S, van der Wal AC, Nieste E, Van de Heyning P, Braem M, Visscher C, Topsakal V, Gilles A, Jacquemin L, Hesters M, De Hertogh W. Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial. Trials. 2018 Oct 12;19(1):554. doi: 10.1186/s13063-018-2903-1. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2024 | |
| Unrelease | Feb 21, 2024 | |
| Release | Feb 21, 2024 | |
| Reset | Aug 2, 2024 | |
| Release | Jan 29, 2025 | |
| Reset | Feb 18, 2025 | |
| Release | Jul 18, 2025 | |
| Reset | Aug 6, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2024 | Feb 21, 2024 | |||
| Feb 21, 2024 |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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.
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| 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 |
| Aug 2, 2024 |
| Jan 29, 2025 | Feb 18, 2025 |
| Jul 18, 2025 | Aug 6, 2025 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |