Urdu Version of Core Outcome Measure Index - Neck Scale: Reliability and Validity Study

Chronic Neck Pain Clinical Trial

Official title:

Prospective Reliability and Validity Study of Urdu Version of Core Outcome Measure Index- Neck Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234255
• Other study ID #: REC-FSD-00247
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: April 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Purpose of this study is to culturally adapt and translate Core outcome measure index-Neck Scale into Urdu language as well as to investigate the reliability and validity in Pakistani population. Also check its correlation with Neck Disability-Index, Neck-pain and the disability-scale and Functional-Rating-Index.

Description:

The English version of the Core outcome measure index-Neck Scale will be translated and culturally adapted Urdu Language. In Patients who suffer from Chronic-Neck Pain, Core outcome measure index-Neck Scale will be distributed among one hundred and twenty participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test intra and inter observation reliabilities for the final Core outcome measure index-Neck Scale, Neck-pain and the Disability Scale, Functional-Rating-Index and Neck-Disability-Index questionnaire will be filled on the same day, by two observers, and for the inter-observer's assessment, with an interval of 30 minute between the first and the second application. Third assessment will be carried out after 7 days by for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Software Version 24. Internal consistency will be analyzed by using Cronbach-alpha-value. Test-retesting reliabilities will assesses using the intraclass correlation coefficient. Core outcome measure index-Neck Scale will be evaluated for content validities, construct validities, and responsiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 25, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals, including both Male and females (age =18).
• Participants with Chronic-Neck Pains lasting more than Three months Duration.
• Participants with sufficient Knowledge and understanding Urdu Language.

Exclusion Criteria:

• Participants with the history of Neck-pains due to deformity, existing central or peripheral nervous disorders and cervical spinal cord fracture were excluded.
• Participants having systematic diseases (tumor or articular Diseases).
• Participants with any Pertinent comorbidities, including heart attack, Cancer, cognitive Impairment's and mental disorders were also excluded.

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

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	Core Outcome Measure Index-Neck	There are five domains in Core Outcome Measure Index - Neck Scale that describe pain, function, symptom specific well-being, quality of life and disability of the patient. In the summary of core outcome measure index-neck each domain score transformed to a 0-10 scale and these are then averaged to give a score of 0 to 10, higher score indicate the severity	1st day
Primary	Neck-Disability-Index	This questionnaire is used to assess the quality and functional activities of daily life. This assessment tool consists of 10 sub-items that includes pain, lifting activities, personally caring, working, headaches, sleep, drive and recreations. This questionnaire is intended to provide us with information on how your neck discomfort has impacted your capacity to function in daily life. The Neck-Disability-Index has enough support and applicability to maintain its position mostly used self-reporting measures for neck discomforts. The Neck-Disability-Index can be administered to assess a patient's current state as well as their progress during treatment.	1st day
Primary	Neck-pain Scale and the Disability Scale	The Neck-pain Scale and the Disabilities Scale is a composition index including about twenty items which measure the intensities of the Neck-pains and related disabilities. The 20-item checklist assesses neck mobility issues, the severity of neck discomforts the impact of neck traumas on the amount of hindrance everyday activity. The Neck-pain and Disability scale is an established tool for assessing results in individuals with neck discomfort It's simple to fill out for the participants, and it's simple to evaluate for the assessors. Its impact on professional, cultural, interpersonal, and practical areas of life, as well as the existence and severity of emotional components connected with it	1st day
Primary	Functional Rating Scale	The Functional Rating Index is a self report questionnaire that describes pain in the neck or back region. There are 10-Items in Functional Rating Index that used to measure pain and functional level. The 5-point scale is used to check the response of the patient, 0 on this scale represents no pain or functional ability and 4 represents sever or worse pain. The Functional Rating Index scores range from 0% to 100%, in which there is no disability at 0% and severe disability on 100%	1st day