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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Other: Cervical physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct treatment<br> | Other: Cervical physical therapy<br>* Patients receive a multimodal cervical physical therapy treatment<br>|
| Experimental: Delayed treatment<br> | Other: Cervical physical therapy<br>* Patients receive a multimodal cervical physical therapy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Questionnaire | change in tinnitus distress after treatment and after follow-up | Baseline, 9 weeks, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index | change in tinnitus severity after treatment and after follow-up | Baseline, 9 weeks, 18 weeks | 
| Neck Bournemouth Questionnaire | change in neck complaints after treatment and after follow-up | Baseline, 9 weeks, 18 weeks | 
| Change in Auditory evoked potentials | EEG measurement during auditory task | Baseline, 9 weeks | 
| Change in Manual Rotation test | clinical test | Baseline, 9 weeks | 
| change in adapted Spurling test | clinical test | baseline, 9 weeks | 
| change in presence of active triggerpoints | clinical test | baseline, 9 weeks | 
| change in Craniocervical flexion test | clinical test | baseline, 9 weeks | 
| change in Coordination and strength test of cervical extensor muscles | clinical test | baseline, 9 weeks | 
| change in Speech in noise test | audiological test | baseline, 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Somatic tinnitus