Clinical trial NCT03209297: Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment
Official title: The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Fonds voor Wetenschappelijk onderzoek Vlaanderen
First posted: 2017-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus Questionnaire
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary outcomes:
measure: Tinnitus Functional Index
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Hyperacusis Questionnaire
timeFrame: Baseline
measure: Visual analogue scale for tinnitus loudness
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: TMD pain screener
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Hospital anxiety and depression scale
timeFrame: Baseline
measure: Specific anamnestic questions
timeFrame: Baseline
measure: Static investigation of the temporomandibular joint
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Dynamic investigation of the temporomandibular joint
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Pain pressure threshold
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Mouth opening
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Pain on palpation of masseter, temporalis and temporomandibular joint
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Tinnitus Analysis
timeFrame: Baseline
measure: Speech in noise test
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Pure tone audiometry
timeFrame: Baseline
measure: Auditory evoked potentials measurement
timeFrame: Baseline, 18 weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair ziekenhuis Antwerpen
state: Antwerpen
Study officials:
References:
citation: 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.