Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment
- Conditions
- Tinnitus, Subjective
- Registration Number
- NCT03209297
- Lead Sponsor
- Universiteit Antwerpen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Tinnitus Questionnaire Baseline, 9 weeks, 18 weeks, 27 weeks Questionnaire to measure the change in tinnitus related distress
- Secondary Outcome Measures
Name Time Method Specific anamnestic questions Baseline pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...
Hyperacusis Questionnaire Baseline Questionnaire to measure the presence of hyperacusis
Visual analogue scale for tinnitus loudness Baseline, 9 weeks, 18 weeks, 27 weeks Scale to measure the change in average tinnitus loudness
Tinnitus Analysis Baseline analysis of the tinnitus type, pitch and loudness
Speech in noise test Baseline, 9 weeks, 18 weeks, 27 weeks analysis of the change in understanding spoken words in a noisy situation
Tinnitus Functional Index Baseline, 9 weeks, 18 weeks, 27 weeks Questionnaire to measure the change in tinnitus severity
Hospital anxiety and depression scale Baseline Questionnaire to measure the presence of anxiety and/or depression
Pain on palpation of masseter, temporalis and temporomandibular joint Baseline, 9 weeks, 18 weeks, 27 weeks change in recognisable pain on palpation, measured on numerical rating scale
Auditory evoked potentials measurement Baseline, 18 weeks change in EEG during listening tasks
TMD pain screener Baseline, 9 weeks, 18 weeks, 27 weeks Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms
Dynamic investigation of the temporomandibular joint Baseline, 9 weeks, 18 weeks, 27 weeks evaluation of change in isotonic contraction of jaw muscles
Mouth opening Baseline, 9 weeks, 18 weeks, 27 weeks change in mouth opening measured in cm with a ruler
Static investigation of the temporomandibular joint Baseline, 9 weeks, 18 weeks, 27 weeks evaluation of change in isometric contraction of jaw muscles
Pain pressure threshold Baseline, 9 weeks, 18 weeks, 27 weeks measurement of change in pain pressure thresholds on masseter, temporalis, temporomandibular joint, sternocleidomastoideus, tibialis anterior
Pure tone audiometry Baseline evaluation of possible hearing problems
Trial Locations
- Locations (1)
Universitair ziekenhuis Antwerpen
🇧🇪Edegem, Antwerpen, Belgium