NCT05221086

Brief Summary

The aim of this study is to translate or culturally adapt ProFitMap-neck into Urdu language and to investigate the reliability and validity of the ProFitMap-neck in Pakistani population having chronic neck pain. Also check it's correlation with Neck Disability Index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

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

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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
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

February 1, 2022

Last Update Submit

July 4, 2022

Conditions

Keywords

Urdu Version of ProFitMap-neckNon-specific Chronic Neck PainPsychometric PropertiesValidityFunctional LimitationsReliability

Outcome Measures

Primary Outcomes (2)

  • ProFitMap-Neck Questionnaire

    The functional limitation scale (function index) and the symptom scale (often and much) are the two original ProFitMap-neck measures,each with 20 and 27 items, respectively. There are six response options for each item, which fall into the following categories. The function index ranges from ''very good, no problems, very satisfying, very likely" to ''very awful, extremely difficult/impossible, extremely dissatisfying, extremely unlikely", Symptom scale with intensity index (how much) ranging from ''nothing/nothing at all" to ''nearly unbearable/ terrible, all/maximally"; The frequency index (how often) ranges from ''never/very seldom" to ''very often/always" on the symptom scale.The index values are scaled from 0 to 100. Higher ratings indicate improved function/health. The intensity index and the frequency index are two different types of indexes.

    1st day

  • Neck Pain Disability Index

    The Neck Pain Disability Index assesses the severity of neck pain symptoms and its impact on daily life. It has ten sections that cover pain intensity, attention/focus, headaches, and daily activities. The items include six response options ranging from no disability (0) to total disability (5), giving a total score of 0 to 50.The Neck Disability index was normalized from 0 to 100 in this study, with higher scores indicating more disability.

    1st day

Eligibility Criteria

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

Pakistani Population with non-specific Chronic Neck Pain.

You may qualify if:

  • Non-specific chronic neck pain Age 18-65 years Neck pain that isn't caused by a traumatic event

You may not qualify if:

  • Neck pain due to any type of surgery Neck pain as a result of an injury Neck pain due to broken bone or dislocation Rheumatological issues Pregnant women Any Cardiovascular disorders Any Neurological problems Cord compression Insufficiency of the vertebrobasilar artery

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 2, 2022

Study Start

May 30, 2021

Primary Completion

February 10, 2022

Study Completion

February 15, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations