- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676141
Responsiveness of the German Version of the Neck Disability Index (NDI-G)
February 20, 2019 updated by: Swanenburg, Balgrist University Hospital
This study evaluates if the German Version of the NDI is sensitive to change over time.
Study Overview
Detailed Description
Chronic neck pain patients will be asked to participate in the study.
The participants are asked to fill out the NDI at the beginning of the study and after seven weeks. Additionally the participants will fill out the PGIC.
Study Type
Observational
Enrollment (Actual)
50
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
-
-
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Zurich, Switzerland, 8008
- Balgrist University Hospital
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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
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with chronic neck pain.
Description
Inclusion Criteria:
- Chronic neck pain
- over 18 years old
- informed consent
- able to speak, write and read German.
Exclusion Criteria:
- Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures
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 |
Measure Description |
Time Frame |
---|---|---|
Change of the German Version of the Neck Disability Index (NDI-G)
Time Frame: Change from Baseline to seven weeks
|
Questionnaire to evaluate the subjective restriction of the participants
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Change from Baseline to seven weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's Global Impression of Change Scale (PGIC)
Time Frame: Seven weeks after the baseline measurement
|
Questionnaire measuring the change of the patient.
|
Seven weeks after the baseline measurement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaap Swanenburg, PhD, Balgrist University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
February 10, 2019
Study Registration Dates
First Submitted
January 29, 2016
First Submitted That Met QC Criteria
February 5, 2016
First Posted (Estimate)
February 8, 2016
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-00068
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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