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The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131674
Recruitment Status : Withdrawn (Ongoing insights required a different approach)
First Posted : April 27, 2017
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Sarah Michiels, Universiteit Antwerpen

Brief Summary:

This study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. This study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions.

These inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.


Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Other: Cervical physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

We use a delayed treatment design, where both groups receive the same treatment.

One group receives the treatment immediately after the inclusion. The other group receives the treatment after a 9-weeks delay.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Direct treatment Other: Cervical physical therapy
Patients receive a multimodal cervical physical therapy treatment

Experimental: Delayed treatment Other: Cervical physical therapy
Patients receive a multimodal cervical physical therapy treatment




Primary Outcome Measures :
  1. Tinnitus Questionnaire [ Time Frame: Baseline, 9 weeks, 18 weeks ]
    change in tinnitus distress after treatment and after follow-up


Secondary Outcome Measures :
  1. Tinnitus Functional Index [ Time Frame: Baseline, 9 weeks, 18 weeks ]
    change in tinnitus severity after treatment and after follow-up

  2. Neck Bournemouth Questionnaire [ Time Frame: Baseline, 9 weeks, 18 weeks ]
    change in neck complaints after treatment and after follow-up

  3. Change in Auditory evoked potentials [ Time Frame: Baseline, 9 weeks ]
    EEG measurement during auditory task

  4. Change in Manual Rotation test [ Time Frame: Baseline, 9 weeks ]
    clinical test

  5. change in adapted Spurling test [ Time Frame: baseline, 9 weeks ]
    clinical test

  6. change in presence of active triggerpoints [ Time Frame: baseline, 9 weeks ]
    clinical test

  7. change in Craniocervical flexion test [ Time Frame: baseline, 9 weeks ]
    clinical test

  8. change in Coordination and strength test of cervical extensor muscles [ Time Frame: baseline, 9 weeks ]
    clinical test

  9. change in Speech in noise test [ Time Frame: baseline, 9 weeks ]
    audiological test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with subjective tinnitus (Tinnitus Functional Index between 25 and 90 point) in combination with self-reported neck complaints (Neck Bournemouth Questionnaire > 13 points) are included in case one of the following is present:

    • Tinnitus and neck complaints increase and decrease together
    • Tinnitus is low-pitched and increases during inadequate neck postures

Exclusion Criteria:

  • Tinnitus related to Ménière's disease, clear otological or neurological causes
  • Serious depression
  • Contra-indications for cervical spine treatment
  • Patient already received cervical physical therapy in the past 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131674


Locations
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Belgium
University Hospital of Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Universiteit Antwerpen
University Hospital, Antwerp
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Responsible Party: Sarah Michiels, Post-doctoral researcher, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03131674    
Other Study ID Numbers: 16/48/512
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Michiels, Universiteit Antwerpen:
Somatic tinnitus
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms