Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Other: TMD treatment: physiotherapy and/or occlusal splints

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium
      • Universitair Ziekenhuis Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct treatment; Patients receive the TMD treatment immediately	Other: TMD treatment: physiotherapy and/or occlusal splints; The patient will receive the most appropriate TMD treatment, based on current literature.
Experimental: Delayed treatment; 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; The patient will receive the most appropriate TMD treatment, based on current literature.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: University Hospital, Antwerp; Fonds voor Wetenschappelijk onderzoek Vlaanderen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: T001916N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No