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

NCT ID: NCT03131674

Last Updated: 2019-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-31

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.

Detailed Description

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Conditions

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Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Direct treatment

Group Type EXPERIMENTAL

Cervical physical therapy

Intervention Type OTHER

Patients receive a multimodal cervical physical therapy treatment

Delayed treatment

Group Type EXPERIMENTAL

Cervical physical therapy

Intervention Type OTHER

Patients receive a multimodal cervical physical therapy treatment

Interventions

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Cervical physical therapy

Patients receive a multimodal cervical physical therapy treatment

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Sarah Michiels

Post-doctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Antwerp

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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16/48/512

Identifier Type: -

Identifier Source: org_study_id

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