Correlation of the Neck Disability Index (NDI) and Voice... | NCT02868762

Studies
Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders

NCT02868762

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Nov 1, 2017Actual

Enrollment

175Actual

Phase

Not provided

Conditions

Neck Pain and/or a Voice Disorder

Interventions

Not provided

Countries

Switzerland

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

Oct 2017

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

Jul 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jul 4, 2016

First Submission Date that Met QC Criteria

Aug 15, 2016

First Posted Date

Aug 16, 2016Estimated

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

Oct 30, 2017

Last Update Posted Date

Nov 1, 2017Actual

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

This study investigates in patients whose primary complaint is either neck pain and/or a voice disorder , if there are any correlations between subjective neck and voice symptoms according to Neck Disability Index (NDI) and Voice Handicap Index (VHI). NDI and VHI questionnaire results for voice disordered patients will be retrieved from the data base of the Department of Phoniatrics and Speech Pathology, University Hospital Zurich. Neck pain patient questionnaire data will be retrieved from an ongoing study. The agreement between subjective neck handicap (NDI) and voice handicap (VHI) will be statistically analysed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between neck disability index and voice handicap index (questionnaire)		1 day

Secondary Outcomes

Measure	Description	Time Frame
Additional neck area handicap in patients with voice disorders (questionnaire)	Patients will fill out the questionnaire once, at the beginning of the study	1 day
Additional subjective voice disorder in patients with neck pain (questionnaire)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old
primary diagnose of a functional disorder of the muscular structure in the neck area
primary diagnose of a functional or secondary structural voice disorder

Exclusion Criteria:

systemic illness of the motion apparatus (i.e., polyarthritis rheumatica)
acute cancer
neurogenic voice and swallow disorder
Intubation within the last 18 months
lack of german knowledge, (not able to fill out a questionnaire independently)

Accepts Healthy Volunteers

Yes

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

primary care clinic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jörg Bohlender, KD Dr.	University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KD Dr. Jörg Bohlender		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019547	Neck Pain
D014832	Voice Disorders

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided