Tinnitus, SubjectiveNCT03209297
Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment
A study testing TMD treatment: physiotherapy and/or occlusal splints in people with Tinnitus, Subjective, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- TMD treatment: physiotherapy and/or occlusal splints
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Mar 2017to 5 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- TMD treatment: physiotherapy and/or occlusal splints
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMD treatment: physiotherapy and/or occlusal splintsOther
The patient will receive the most appropriate TMD treatment, based on current literature.
| Study group | Role | What they receive |
|---|---|---|
| Direct treatment | Experimental | Patients receive the TMD treatment immediately Receives: 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 Receives: Other: TMD treatment: physiotherapy and/or occlusal splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Questionnaire
Questionnaire to measure the change in tinnitus related distress
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary outcomes (15)
Tinnitus Functional Index
Questionnaire to measure the change in tinnitus severity
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Hyperacusis Questionnaire
Questionnaire to measure the presence of hyperacusis
Measured: Baseline
Visual analogue scale for tinnitus loudness
Scale to measure the change in average tinnitus loudness
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
TMD pain screener
Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Hospital anxiety and depression scale
Questionnaire to measure the presence of anxiety and/or depression
Measured: Baseline
Specific anamnestic questions
pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...
Measured: Baseline
Static investigation of the temporomandibular joint
evaluation of change in isometric contraction of jaw muscles
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Dynamic investigation of the temporomandibular joint
evaluation of change in isotonic contraction of jaw muscles
Measured: 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
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Mouth opening
change in mouth opening measured in cm with a ruler
Measured: 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
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Tinnitus Analysis
analysis of the tinnitus type, pitch and loudness
Measured: Baseline
Speech in noise test
analysis of the change in understanding spoken words in a noisy situation
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Pure tone audiometry
evaluation of possible hearing problems
Measured: Baseline
Auditory evoked potentials measurement
change in EEG during listening tasks
Measured: Baseline, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start27 Mar 2017
- Primary completion30 Mar 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Fonds voor Wetenschappelijk onderzoek Vlaanderen
- Responsible party
- Principal investigator, Sarah Michiels, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209297
- Sponsor's protocol ID
- T001916N
- Status last verified
- Nov 2019
- First submitted
- 19 Apr 2017
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30314506
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus
- ClinicalTrials.gov ID
- NCT03209297
- Acronym / sponsor ID
- T001916N
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Fonds voor Wetenschappelijk onderzoek Vlaanderen
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Direct treatment | Experimental | Other: TMD treatment: physiotherapy and/or occlusal splintsPatients receive the TMD treatment immediately |
| Delayed treatment | Experimental | Other: TMD treatment: physiotherapy and/or occlusal splintsNo intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMD treatment: physiotherapy and/or occlusal splintsThe patient will receive the most appropriate TMD treatment, based on current literature. | Other | Delayed treatment, Direct treatment |
Primary outcome
Tinnitus Questionnaire
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Questionnaire to measure the change in tinnitus related distress
15 secondary outcomes
Tinnitus Functional Index
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Hyperacusis Questionnaire
Time frame: Baseline
Visual analogue scale for tinnitus loudness
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
TMD pain screener
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Hospital anxiety and depression scale
Time frame: Baseline
Specific anamnestic questions
Time frame: Baseline
Static investigation of the temporomandibular joint
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Dynamic investigation of the temporomandibular joint
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Pain pressure threshold
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Mouth opening
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Pain on palpation of masseter, temporalis and temporomandibular joint
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Tinnitus Analysis
Time frame: Baseline
Speech in noise test
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Pure tone audiometry
Time frame: Baseline
Auditory evoked potentials measurement
Time frame: Baseline, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Derived from this study: PubMed 30314506Michiels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMD treatment: physiotherapy and/or occlusal splints in people with Tinnitus, Subjective, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Questionnaire (time frame: Baseline, 9 weeks, 18 weeks, 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.