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The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

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

Inclusion Criteria:

  • severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints

Exclusion Criteria:

  • objective tinnitus
  • subjective tinnitus with etiologies, such as hearing loss or Meniere's disease, severe depression (> 19 on the Beck depression questionnaire)
  • progressive middle ear pathology
  • intracranial pathology
  • traumatic cervical spine injury
  • tumors
  • cervical spine surgery
  • any cervical spine condition in which physical therapy treatment is contra- indicated
  • received physical therapy treatment directed to the cervical spine in the past 2 months

Sites / Locations

  • University Hospital of Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Immediate therapy

waiting list

Arm Description

Physiotherapy protocol

Physiotherapy protocol

Outcomes

Primary Outcome Measures

Change in Tinnitus Functional Index

Secondary Outcome Measures

Full Information

First Posted
December 9, 2013
Last Updated
December 3, 2014
Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT02016313
Brief Title
The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus
Official Title
Evaluation of the Effect of Cervical Spine Treatment in Tinnitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether physiotherapy is effective in the treatment of a group of tinnitus patients with neck complaints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate therapy
Arm Type
Experimental
Arm Description
Physiotherapy protocol
Arm Title
waiting list
Arm Type
Placebo Comparator
Arm Description
Physiotherapy protocol
Intervention Type
Other
Intervention Name(s)
physiotherapy
Primary Outcome Measure Information:
Title
Change in Tinnitus Functional Index
Time Frame
pre treatment, post treatment, 6 and 12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints Exclusion Criteria: objective tinnitus subjective tinnitus with etiologies, such as hearing loss or Meniere's disease, severe depression (> 19 on the Beck depression questionnaire) progressive middle ear pathology intracranial pathology traumatic cervical spine injury tumors cervical spine surgery any cervical spine condition in which physical therapy treatment is contra- indicated received physical therapy treatment directed to the cervical spine in the past 2 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Van de Heyning, PhD, MD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Willem De Hertogh, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
27592038
Citation
Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016 Dec;26:125-131. doi: 10.1016/j.math.2016.08.005. Epub 2016 Aug 26.
Results Reference
derived
PubMed Identifier
25056151
Citation
Michiels S, De Hertogh W, Truijen S, Van de Heyning P. Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial. Trials. 2014 Jul 22;15:297. doi: 10.1186/1745-6215-15-297.
Results Reference
derived

Learn more about this trial

The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

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