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Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

Primary Purpose

Tinnitus, Subjective

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
TMD treatment: physiotherapy and/or occlusal splints
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair ziekenhuis Antwerpen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Direct treatment

Delayed treatment

Arm Description

Patients receive the TMD treatment immediately

No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group

Outcomes

Primary Outcome Measures

Tinnitus Questionnaire
Questionnaire to measure the change in tinnitus related distress

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2017
Last Updated
November 5, 2019
Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp, Fonds voor Wetenschappelijk onderzoek Vlaanderen
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1. Study Identification

Unique Protocol Identification Number
NCT03209297
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp, Fonds voor Wetenschappelijk onderzoek Vlaanderen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct treatment
Arm Type
Experimental
Arm Description
Patients receive the TMD treatment immediately
Arm Title
Delayed treatment
Arm Type
Experimental
Arm Description
No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group
Intervention Type
Other
Intervention Name(s)
TMD treatment: physiotherapy and/or occlusal splints
Intervention Description
The patient will receive the most appropriate TMD treatment, based on current literature.
Primary Outcome Measure Information:
Title
Tinnitus Questionnaire
Description
Questionnaire to measure the change in tinnitus related distress
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary Outcome Measure Information:
Title
Tinnitus Functional Index
Description
Questionnaire to measure the change in tinnitus severity
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Hyperacusis Questionnaire
Description
Questionnaire to measure the presence of hyperacusis
Time Frame
Baseline
Title
Visual analogue scale for tinnitus loudness
Description
Scale to measure the change in average tinnitus loudness
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
TMD pain screener
Description
Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Hospital anxiety and depression scale
Description
Questionnaire to measure the presence of anxiety and/or depression
Time Frame
Baseline
Title
Specific anamnestic questions
Description
pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...
Time Frame
Baseline
Title
Static investigation of the temporomandibular joint
Description
evaluation of change in isometric contraction of jaw muscles
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Dynamic investigation of the temporomandibular joint
Description
evaluation of change in isotonic contraction of jaw muscles
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Pain pressure threshold
Description
measurement of change in pain pressure thresholds on masseter, temporalis, temporomandibular joint, sternocleidomastoideus, tibialis anterior
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Mouth opening
Description
change in mouth opening measured in cm with a ruler
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Pain on palpation of masseter, temporalis and temporomandibular joint
Description
change in recognisable pain on palpation, measured on numerical rating scale
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Tinnitus Analysis
Description
analysis of the tinnitus type, pitch and loudness
Time Frame
Baseline
Title
Speech in noise test
Description
analysis of the change in understanding spoken words in a noisy situation
Time Frame
Baseline, 9 weeks, 18 weeks, 27 weeks
Title
Pure tone audiometry
Description
evaluation of possible hearing problems
Time Frame
Baseline
Title
Auditory evoked potentials measurement
Description
change in EEG during listening tasks
Time Frame
Baseline, 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universitair ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerpen
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30314506
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.
Results Reference
derived

Learn more about this trial

Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

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