The Effect of Cervical Physical Therapy Treatment in Pati... | NCT03131674

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

NCT03131674

Sponsor

Universiteit Antwerpen

Status

Withdrawn

Last Update Posted

Jun 13, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Tinnitus, Subjective

Interventions

Cervical physical therapy

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

Jun 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Ongoing insights required a different approach

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Apr 19, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 27, 2017Actual

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

Jun 11, 2019

Last Update Posted Date

Jun 13, 2019Actual

Name	Class
University Hospital, Antwerp	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Direct treatment	Experimental		Other: Cervical physical therapy
Delayed treatment	Experimental		Other: Cervical physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cervical physical therapy	Other	Patients receive a multimodal cervical physical therapy treatment	Delayed treatment Direct treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.