- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05440474
Urdu Version of COPENHAGEN Neck Functional Disability Scale: Reliability and Validity Study
December 19, 2023 updated by: Riphah International University
A Reliability and Validity Study of Urdu Version of COPENHAGEN Neck Functional Disability Scale in Patients With Chronic Neck Pain
- The objective of the research is to do translation and to culturally familiarize the COPENHAGEN Neck Functional Disability Scale into the Urdu language.
- To investigate if the COPENHAGEN Neck Functional Disability Scale is reliable and validate in the Pakistani population with Chronic Neck pain.
- To check the correlation with Neck Disability Index, Neck Pain and Disability Scale.
Study Overview
Status
Completed
Conditions
Detailed Description
The English version of the COPENHAGEN Neck Functional Disability Scale will be translated into Urdu and culturally adapted, as per a previous recommendation.
The COPENHAGEN Neck Functional Disability Scale will be given to participants who have consented, and would be chosen based on convenience sampling and inclusion and exclusion criteria.
The inter-observer and intra-observer reliability of the COPENHAGEN Neck Functional Disability Scale, Neck Pain and Disability Scale , and Neck Disability Index will be evaluated in this study.
On the same day, the questionnaire will be filled out created two times.
An Inter - observer assessment will be done with 2 hour break between distributions of questionnaires.
The initial observer then will gather a third assessment over one-week period.
For data entry and analysis, Statistical Package of Social Sciences Version 23 will be utilized.
Internal consistency will be checked using the Cronbach alpha value, and test retest reliability will be assessed using the Intra-class coefficient.
Study Type
Observational
Enrollment (Actual)
3000
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
-
-
Punjab
-
Faisalabad, Punjab, Pakistan, 38000
- ripah international university
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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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pakistani population with Chronic Neck pain will be part of the study.
Description
Inclusion Criteria:
- From 20 years Old to 60 Years Old
- Participants with chronic Neck pain
- The patient having minimum cervical ROM and pain.
- Patient not taking medicine.
- No intervention between the test-retest assessments.
Exclusion Criteria:
To complete the forms because of a psychological Impairment, history or presence of;
- Rheumatic diseases, severe articulation inflammation, and cardiac disease.
- History of previous cervical or thoracic spine injury
- Any systematic disease with an unstable spine
- Illiteracy or lack of understanding of Urdu Language
- The presence of neurologic or musculoskeletal disorders other than the Neck Condition.
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
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COPENHAGEN Neck Functional Disability Scale
Time Frame: day 1
|
Item 1 & 5 on this three-dimensional scale assess pain severity, while items 2, 3, 4, 5, 7, 8, 9, 10, and 12 assess disability in everyday tasks, while items 6, 9, 11, 13, and 14 assess social contacts and recreational activities.
The entire score varies from 0 to 30
|
day 1
|
|
Neck Pain and Disability Scale
Time Frame: day 1
|
The Neck Pain and Disability Scale is a multidimensional form with 20 items that cover four dimensions: neck issues, pain intensity, the impact of neck pain on emotion, and the impact of neck pain on daily activities
|
day 1
|
|
Neck Disability Index
Time Frame: day 1
|
Neck Disability Index includes ten questions that assess pain intensity, personal care, lifting, reading, headaches, attention, work, driving, sleeping, and recreational activities.
Every question is graded on a scale of 0 to 5 (no disability to total disability).
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Muhammad Kashif, Riphah International University
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)
May 30, 2021
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
June 27, 2022
First Submitted That Met QC Criteria
June 27, 2022
First Posted (Actual)
June 30, 2022
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/FSD/0287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.