Chronic Neck PainNCT05234255
Urdu Version of Core Outcome Measure Index - Neck Scale: Reliability and Validity Study
An observational study of Chronic Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neck Pain
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 25 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The people included in this study were chronic neck pain Individuals (Both Genders) Among Urdu speaking Pakistani population.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Prospective Reliability and Validity Study of Urdu Version of Core Outcome Measure Index- Neck Scale
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.
Read the detailed description
The English version of the Core outcome measure index-Neck Scale will be translated and culturally adapted Urdu Language. In Patients who suffer from Chronic-Neck Pain, Core outcome measure index-Neck Scale will be distributed among one hundred and twenty participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test intra and inter observation reliabilities for the final Core outcome measure index-Neck Scale, Neck-pain and the Disability Scale, Functional-Rating-Index and Neck-Disability-Index questionnaire will be filled on the same day, by two observers, and for the inter-observer's assessment, with an interval of 30 minute between the first and the second application. Third assessment will be carried out after 7 days by for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Software Version 24. Internal consistency will be analyzed by using Cronbach-alpha-value. Test-retesting reliabilities will assesses using the intraclass correlation coefficient. Core outcome measure index-Neck Scale will be evaluated for content validities, construct validities, and responsiveness.
- Conditions
- Chronic Neck Pain
- Keywords
- Core Outcome Measure Index-NECK SCALE, Chronic Neck Pain, reliability, Validity, Urdu Version
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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%
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 posted10 Feb 2022
- Study start30 May 2021
- Primary completion17 Feb 2022
- Study completion25 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
- 120 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
- NCT05234255
- Sponsor's protocol ID
- REC-FSD-00247
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2022
- Last updated
- 5 Apr 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Reliability and Validity Study of Urdu Version of Core Outcome Measure Index- Neck Scale
- ClinicalTrials.gov ID
- NCT05234255
- Acronym / sponsor ID
- REC-FSD-00247
- Conditions
- Chronic Neck Pain
- Keywords
- Core Outcome Measure Index-NECK SCALE, Chronic Neck Pain, reliability, Validity, Urdu Version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 10 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 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.
Detailed description
The English version of the Core outcome measure index-Neck Scale will be translated and culturally adapted Urdu Language. In Patients who suffer from Chronic-Neck Pain, Core outcome measure index-Neck Scale will be distributed among one hundred and twenty participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test intra and inter observation reliabilities for the final Core outcome measure index-Neck Scale, Neck-pain and the Disability Scale, Functional-Rating-Index and Neck-Disability-Index questionnaire will be filled on the same day, by two observers, and for the inter-observer's assessment, with an interval of 30 minute between the first and the second application. Third assessment will be carried out after 7 days by for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Software Version 24. Internal consistency will be analyzed by using Cronbach-alpha-value. Test-retesting reliabilities will assesses using the intraclass correlation coefficient. Core outcome measure index-Neck Scale will be evaluated for content validities, construct validities, and responsiveness.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The people included in this study were chronic neck pain Individuals (Both Genders) Among Urdu speaking Pakistani population.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
Core Outcome Measure Index-Neck
Time frame: 1st day
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
Neck-Disability-Index
Time frame: 1st day
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.
Neck-pain Scale and the Disability Scale
Time frame: 1st day
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
Functional Rating Scale
Time frame: 1st day
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%
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 5 Apr 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 3 inclusion and 3 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 5 Apr 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?
Core Outcome Measure Index-Neck (time frame: 1st day). The study lists 4 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 5 Apr 2022.