Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

NCT03209297 | Completed

• 1 other identifier: T001916N
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

• Tinnitus Questionnaire

  Questionnaire to measure the change in tinnitus related distress

  Baseline, 9 weeks, 18 weeks, 27 weeks

Secondary Outcomes (15)

• Tinnitus Functional Index

  Baseline, 9 weeks, 18 weeks, 27 weeks

• Hyperacusis Questionnaire

  Baseline

• Visual analogue scale for tinnitus loudness

  Baseline, 9 weeks, 18 weeks, 27 weeks

• TMD pain screener

  Baseline, 9 weeks, 18 weeks, 27 weeks

• Hospital anxiety and depression scale

  Baseline

Study Arms (2)

Direct treatment

EXPERIMENTAL

Patients receive the TMD treatment immediately

Other: TMD treatment: physiotherapy and/or occlusal splints

Delayed treatment

EXPERIMENTAL

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

Interventions

TMD treatment: physiotherapy and/or occlusal splints OTHER

The patient will receive the most appropriate TMD treatment, based on current literature.

Delayed treatment; Direct treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator
• Fonds voor Wetenschappelijk onderzoek Vlaanderen: collaborator

Study Sites (1)

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Location

Related Publications (1)

• 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.

  PMID: 30314506 DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral researcher

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: July 6, 2017
• Study Start: March 27, 2017
• Primary Completion: March 30, 2019
• Study Completion: November 5, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)