- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868762
Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders
October 30, 2017 updated by: University of Zurich
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
175
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8091
- KD Dr. Jörg Bohlender
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary care clinic patients
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between neck disability index and voice handicap index (questionnaire)
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Additional neck area handicap in patients with voice disorders (questionnaire)
Time Frame: 1 day
|
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)
Time Frame: 1 day
|
Patients will fill out the questionnaire once, at the beginning of the study
|
1 day
|
|
Difference in pain strength and quality in patients with functional voice disorder as compared to patients with benign organical vocal fold changes (questionnaire)
Time Frame: 1 day
|
Patients will fill out the questionnaire once, at the beginning of the study
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jörg Bohlender, KD Dr., University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
July 4, 2016
First Submitted That Met QC Criteria
August 15, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Actual)
November 1, 2017
Last Update Submitted That Met QC Criteria
October 30, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJ_23_03_2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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