NCT05440474

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

June 27, 2022

Last Update Submit

December 19, 2023

Conditions

Keywords

COPENHAGEN Neck Functional Disability ScaleUrdu VersionReliabilityValidityNeck Disability

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pakistani population with Chronic Neck pain will be part of the study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

May 30, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations