Urdu Version of COPENHAGEN Neck Functional Disability Scale: Reliability and Validity Study

Disability Physical Clinical Trial

Official title:

A Reliability and Validity Study of Urdu Version of COPENHAGEN Neck Functional Disability Scale in Patients With Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440474
• Other study ID #: REC/FSD/0287
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

• To check the correlation with Neck Disability Index, Neck Pain and Disability Scale.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disability Physical

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 1
Primary	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	day 1
Primary	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).	day 1