NCT05234255

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

February 1, 2022

Last Update Submit

April 2, 2022

Conditions

Keywords

Core Outcome Measure Index-NECK SCALEChronic Neck PainreliabilityValidityUrdu Version

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The people included in this study were chronic neck pain Individuals (Both Genders) Among Urdu speaking Pakistani population.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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

February 1, 2022

First Posted

February 10, 2022

Study Start

May 30, 2021

Primary Completion

February 17, 2022

Study Completion

February 25, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations