Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

• Sponsor: Universiteit Antwerpen
• Collaborators: University Hospital, Antwerp; Fonds voor Wetenschappelijk onderzoek Vlaanderen
• Information provided by (Responsible Party): Sarah Michiels, Universiteit Antwerpen

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.

Condition or disease	Intervention/treatment	Phase
Tinnitus, Subjective	Other: TMD treatment: physiotherapy and/or occlusal splints	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus
• Actual Study Start Date: March 27, 2017
• Actual Primary Completion Date: March 30, 2019
• Estimated Study Completion Date: October 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Tinnitus Questionnaire [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   Questionnaire to measure the change in tinnitus related distress

Secondary Outcome Measures :

1. Tinnitus Functional Index [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   Questionnaire to measure the change in tinnitus severity
2. Hyperacusis Questionnaire [ Time Frame: Baseline ]
   Questionnaire to measure the presence of hyperacusis
3. Visual analogue scale for tinnitus loudness [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   Scale to measure the change in average tinnitus loudness
4. TMD pain screener [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms
5. Hospital anxiety and depression scale [ Time Frame: Baseline ]
   Questionnaire to measure the presence of anxiety and/or depression
6. Specific anamnestic questions [ Time Frame: Baseline ]
   pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...
7. Static investigation of the temporomandibular joint [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   evaluation of change in isometric contraction of jaw muscles
8. Dynamic investigation of the temporomandibular joint [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   evaluation of change in isotonic contraction of jaw muscles
9. Pain pressure threshold [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
   measurement of change in pain pressure thresholds on masseter, temporalis, temporomandibular joint, sternocleidomastoideus, tibialis anterior
10. Mouth opening [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    change in mouth opening measured in cm with a ruler
11. Pain on palpation of masseter, temporalis and temporomandibular joint [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    change in recognisable pain on palpation, measured on numerical rating scale
12. Tinnitus Analysis [ Time Frame: Baseline ]
    analysis of the tinnitus type, pitch and loudness
13. Speech in noise test [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    analysis of the change in understanding spoken words in a noisy situation
14. Pure tone audiometry [ Time Frame: Baseline ]
    evaluation of possible hearing problems
15. Auditory evoked potentials measurement [ Time Frame: Baseline, 18 weeks ]
    change in EEG during listening tasks

Eligibility Criteria

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

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

Contacts and Locations

Locations

Belgium

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Sponsors and Collaborators

Universiteit Antwerpen

University Hospital, Antwerp

Fonds voor Wetenschappelijk onderzoek Vlaanderen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sarah Michiels, Post-doctoral researcher, Universiteit Antwerpen
• ClinicalTrials.gov Identifier: NCT03209297 History of Changes
• Other Study ID Numbers: T001916N
• First Posted: July 6, 2017
• Last Update Posted: June 12, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Salicylic Acid; Anti-Infective Agents; Antifungal Agents; Keratolytic Agents; Dermatologic Agents