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

Primary Purpose

Tinnitus, Subjective

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cervical physical therapy
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective focused on measuring Somatic tinnitus

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Direct treatment

Delayed treatment

Arm Description

Outcomes

Primary Outcome Measures

Tinnitus Questionnaire
change in tinnitus distress after treatment and after follow-up

Secondary Outcome Measures

Tinnitus Functional Index
change in tinnitus severity after treatment and after follow-up
Neck Bournemouth Questionnaire
change in neck complaints after treatment and after follow-up
Change in Auditory evoked potentials
EEG measurement during auditory task
Change in Manual Rotation test
clinical test
change in adapted Spurling test
clinical test
change in presence of active triggerpoints
clinical test
change in Craniocervical flexion test
clinical test
change in Coordination and strength test of cervical extensor muscles
clinical test
change in Speech in noise test
audiological test

Full Information

First Posted
April 19, 2017
Last Updated
June 11, 2019
Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT03131674
Brief Title
The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
Official Title
The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Ongoing insights required a different approach
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
Keywords
Somatic tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct treatment
Arm Type
Experimental
Arm Title
Delayed treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cervical physical therapy
Intervention Description
Patients receive a multimodal cervical physical therapy treatment
Primary Outcome Measure Information:
Title
Tinnitus Questionnaire
Description
change in tinnitus distress after treatment and after follow-up
Time Frame
Baseline, 9 weeks, 18 weeks
Secondary Outcome Measure Information:
Title
Tinnitus Functional Index
Description
change in tinnitus severity after treatment and after follow-up
Time Frame
Baseline, 9 weeks, 18 weeks
Title
Neck Bournemouth Questionnaire
Description
change in neck complaints after treatment and after follow-up
Time Frame
Baseline, 9 weeks, 18 weeks
Title
Change in Auditory evoked potentials
Description
EEG measurement during auditory task
Time Frame
Baseline, 9 weeks
Title
Change in Manual Rotation test
Description
clinical test
Time Frame
Baseline, 9 weeks
Title
change in adapted Spurling test
Description
clinical test
Time Frame
baseline, 9 weeks
Title
change in presence of active triggerpoints
Description
clinical test
Time Frame
baseline, 9 weeks
Title
change in Craniocervical flexion test
Description
clinical test
Time Frame
baseline, 9 weeks
Title
change in Coordination and strength test of cervical extensor muscles
Description
clinical test
Time Frame
baseline, 9 weeks
Title
change in Speech in noise test
Description
audiological test
Time Frame
baseline, 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital of Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

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

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