Neck Pain and/or a Voice DisorderNCT02868762
Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders
An observational study of Neck Pain and/or a Voice Disorder, run by University of Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain and/or a Voice Disorder
- How many people
- 175 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Jul 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic patients
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neck Pain and/or a Voice Disorder
- Keywords
- neck pain, voice disorder
- Medical subject headings
- Neck Pain, Voice Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between neck disability index and voice handicap index (questionnaire)
Measured: 1 day
Secondary outcomes (3)
Additional neck area handicap in patients with voice disorders (questionnaire)
Patients will fill out the questionnaire once, at the beginning of the study
Measured: 1 day
Additional subjective voice disorder in patients with neck pain (questionnaire)
Patients will fill out the questionnaire once, at the beginning of the study
Measured: 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)
Patients will fill out the questionnaire once, at the beginning of the study
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain and/or a Voice DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg Bohlender, KD Dr., Principal investigator, University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868762
- Sponsor's protocol ID
- BJ_23_03_2016
- Status last verified
- Oct 2017
- First submitted
- 4 Jul 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders
- ClinicalTrials.gov ID
- NCT02868762
- Acronym / sponsor ID
- BJ_23_03_2016
- Conditions
- Neck Pain and/or a Voice Disorder
- Keywords
- neck pain, voice disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between neck disability index and voice handicap index (questionnaire)
Time frame: 1 day
3 secondary outcomes
Additional neck area handicap in patients with voice disorders (questionnaire)
Time frame: 1 day
Additional subjective voice disorder in patients with neck pain (questionnaire)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Bohlender, KD Dr. principal investigator
University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and/or a Voice Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between neck disability index and voice handicap index (questionnaire) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.