The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus | NCT02016313

Studies
The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

NCT02016313

Sponsor

Universiteit Antwerpen

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Tinnitus

Interventions

physiotherapy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 9, 2013

First Submission Date that Met QC Criteria

Dec 13, 2013

First Posted Date

Dec 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Michiels, Assistent Rehabilitation Sciences and Physical Therapy, Universiteit AntwerpenPrincipal Investigator

Lead Sponsor

Universiteit AntwerpenOTHER

Collaborators

Name	Class
University Hospital, Antwerp	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate therapy	Experimental	Physiotherapy protocol	Other: physiotherapy
waiting list	Placebo Comparator	Physiotherapy protocol	Other: physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physiotherapy	Other		Immediate therapy waiting list

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Tinnitus Functional Index		pre treatment, post treatment, 6 and 12 months follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Van de Heyning, PhD, MD	Universiteit Antwerpen	Study Chair
Willem De Hertogh, PhD	Universiteit Antwerpen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Antwerp		Edegem	Antwerp	2650	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27592038	Derived	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.
25056151	Derived	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.

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

ID	Term
D013812	Therapeutics
D012046	Rehabilitation