- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221086
Urdu Version Of ProFitMap-Neck Questionnaire In Population With Chronic Neck Pain A Reliability And Validity Study
July 4, 2022 updated by: Riphah International University
Urdu Version of The ProFitMap-neck - Reliability and Validity of a Questionnaire for Measuring Symptoms and Functional Limitations in Chronic Neck Pain
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.
Study Overview
Status
Completed
Conditions
Detailed Description
As with prior suggestions, the English version of the ProFitMap-neck will be translated and culturally modified.In population having Chronic Neck Pain ProFitMap-neck will be distributed among one hundred and thirty six participants selected by a convenience sampling technique based on pre-defined inclusion and exclusion criteria.The questionnaire will be filled out by two observers on the same day to examine inter and intra-observer reliability of the final ProFitMap-neck and neck disability index.
For the inter-observer evaluation, there will be a 2 hour delay between the first and second application.
After 7 days, observer-1 will conduct a third assessment (re-testing) for intra-observer evaluation.The Statistical Package of Social Sciences program will be used to examine the data.
Study Type
Observational
Enrollment (Actual)
136
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pakistani Population with non-specific Chronic Neck Pain.
Description
Inclusion Criteria
Non-specific chronic neck pain Age 18-65 years Neck pain that isn't caused by a traumatic event
Exclusion Criteria
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ProFitMap-Neck Questionnaire
Time Frame: 1st day
|
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
Time Frame: 1st day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 30, 2021
Primary Completion (ACTUAL)
February 10, 2022
Study Completion (ACTUAL)
February 15, 2022
Study Registration Dates
First Submitted
February 1, 2022
First Submitted That Met QC Criteria
February 1, 2022
First Posted (ACTUAL)
February 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-00260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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