Disability PhysicalNCT05440474
Urdu Version of COPENHAGEN Neck Functional Disability Scale: Reliability and Validity Study
An observational study of Disability Physical, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Disability Physical
- How many people
- 3,000 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 30 Jul 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pakistani population with Chronic Neck pain will be part of the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Disability Physical
- Keywords
- COPENHAGEN Neck Functional Disability Scale, Urdu Version, Reliability, Validity, Neck Disability
What is being measured
The primary outcome is the main question the study is designed to answer.
COPENHAGEN Neck Functional Disability Scale
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
Measured: day 1
Neck Pain and Disability Scale
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
Measured: day 1
Neck Disability Index
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).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start30 May 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440474
- Sponsor's protocol ID
- REC/FSD/0287
- Status last verified
- Dec 2023
- First submitted
- 27 Jun 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reliability and Validity Study of Urdu Version of COPENHAGEN Neck Functional Disability Scale in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05440474
- Acronym / sponsor ID
- REC/FSD/0287
- Conditions
- Disability Physical
- Keywords
- COPENHAGEN Neck Functional Disability Scale, Urdu Version, Reliability, Validity, Neck Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- 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.
- 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pakistani population with Chronic Neck pain will be part of the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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
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
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
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).
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 22 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Muhammad Kashif study chair
Riphah International University
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 Disability Physical, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 6 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 22 Dec 2023. 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 Pakistan. 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?
COPENHAGEN Neck Functional Disability Scale (time frame: day 1). The study lists 3 primary outcomes in all. 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 22 Dec 2023.