Chronic Neck PainNCT05221086
Urdu Version Of ProFitMap-Neck Questionnaire In Population With Chronic Neck Pain A Reliability And Validity Study
An observational study of Chronic Neck Pain, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 15 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani Population with non-specific Chronic Neck Pain.
Who may be able to join
- Non-specific chronic neck pain Age 18-65 years Neck pain that isn't caused by a traumatic event
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Neck Pain
- Keywords
- Urdu Version of ProFitMap-neck, Non-specific Chronic Neck Pain, Psychometric Properties, Validity, Functional Limitations, Reliability
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start30 May 2021
- Primary completion10 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221086
- Sponsor's protocol ID
- REC-FSD-00260
- Status last verified
- Jul 2022
- First submitted
- 1 Feb 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Version of The ProFitMap-neck - Reliability and Validity of a Questionnaire for Measuring Symptoms and Functional Limitations in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05221086
- Acronym / sponsor ID
- REC-FSD-00260
- Conditions
- Chronic Neck Pain
- Keywords
- Urdu Version of ProFitMap-neck, Non-specific Chronic Neck Pain, Psychometric Properties, Validity, Functional Limitations, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pakistani Population with non-specific Chronic Neck Pain.
Key inclusion criteria (1 listed)
- Non-specific chronic neck pain Age 18-65 years Neck pain that isn't caused by a traumatic event
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ProFitMap-Neck Questionnaire (time frame: 1st day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.