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Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

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ClinicalTrials.gov Identifier: NCT03209297
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
University Hospital, Antwerp
Fonds voor Wetenschappelijk onderzoek Vlaanderen
Information provided by (Responsible Party):
Sarah Michiels, Universiteit Antwerpen

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE March 27, 2017
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
Tinnitus Questionnaire [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
Questionnaire to measure the change in tinnitus related distress
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • Tinnitus Functional Index [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    Questionnaire to measure the change in tinnitus severity
  • Hyperacusis Questionnaire [ Time Frame: Baseline ]
    Questionnaire to measure the presence of hyperacusis
  • Visual analogue scale for tinnitus loudness [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    Scale to measure the change in average tinnitus loudness
  • 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
  • Hospital anxiety and depression scale [ Time Frame: Baseline ]
    Questionnaire to measure the presence of anxiety and/or depression
  • Specific anamnestic questions [ Time Frame: Baseline ]
    pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...
  • Static investigation of the temporomandibular joint [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    evaluation of change in isometric contraction of jaw muscles
  • Dynamic investigation of the temporomandibular joint [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    evaluation of change in isotonic contraction of jaw muscles
  • 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
  • Mouth opening [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    change in mouth opening measured in cm with a ruler
  • 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
  • Tinnitus Analysis [ Time Frame: Baseline ]
    analysis of the tinnitus type, pitch and loudness
  • 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
  • Pure tone audiometry [ Time Frame: Baseline ]
    evaluation of possible hearing problems
  • Auditory evoked potentials measurement [ Time Frame: Baseline, 18 weeks ]
    change in EEG during listening tasks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment
Official Title  ICMJE The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Tinnitus, Subjective
Intervention  ICMJE Other: TMD treatment: physiotherapy and/or occlusal splints
The patient will receive the most appropriate TMD treatment, based on current literature.
Study Arms  ICMJE
  • Experimental: Direct treatment
    Patients receive the TMD treatment immediately
    Intervention: Other: TMD treatment: physiotherapy and/or occlusal splints
  • Experimental: Delayed treatment
    No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group
    Intervention: Other: TMD treatment: physiotherapy and/or occlusal splints
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2017)
200
Actual Study Completion Date  ICMJE November 5, 2019
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209297
Other Study ID Numbers  ICMJE T001916N
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sarah Michiels, Universiteit Antwerpen
Study Sponsor  ICMJE Universiteit Antwerpen
Collaborators  ICMJE
  • University Hospital, Antwerp
  • Fonds voor Wetenschappelijk onderzoek Vlaanderen
Investigators  ICMJE Not Provided
PRS Account Universiteit Antwerpen
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP