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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05221086
Other study ID # REC-FSD-00260
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date February 15, 2022

Study information

Verified date July 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date February 15, 2022
Est. primary completion date February 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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 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
Primary 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
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