Neck PainNCT05221073
Urdu Version Of The Bournemouth Questionnaire For Neck Pain: A Reliability And Validity Study
An observational study of Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study is to translate \& culturally adapt Neck Bournemouth Questionnaire into Urdu language along with investigation of the reliability \& validity of Neck Bournemouth Questionnaire in General Population of Pakistan and to correlate with Neck Disability Index, Visual Analogue Scale, Neck Pain and Disability… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 28 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: General Population of Pakistan with Neck Pain was included in the study
Who may be able to join
- 18 to 65 years of age
- 3 months of neck pain
- Neck pain more than six moth
- Male female both genders
- Physician referral
- Not prescribed medicine
- Without deformity in neck
- Ability of reading and writing
Who cannot join
- Joint inflammation or infection
- Pathology of shoulder
- Fibromylgia
- Psychologically unstable or having neurological disorder
- Cancer history
- Cervical injury
Show all 11Show fewer
- Took treatment of physical therapy in last 6 month
- Any disability
- Loss of memory
- Disease or any Red flag
- Using Neck immobilization device
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Cross-cultural Adaptation and Psychometric Evaluation of the Bournemouth Questionnaire for Neck Pain
The aim of study is to translate \& culturally adapt Neck Bournemouth Questionnaire into Urdu language along with investigation of the reliability \& validity of Neck Bournemouth Questionnaire in General Population of Pakistan and to correlate with Neck Disability Index, Visual Analogue Scale, Neck Pain and Disability Scale and Rand 36-Item Health Survey
Read the detailed description
The English version of the Bournemouth Questionnaire for Neck Pain will be translated and culturally adapted as per as previous recommendations. In the general population with neck pain, Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be distributed among participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. Test inter and intra- observer reliability of the final Urdu Version Of The Bournemouth Questionnaire For Neck Pain with Neck Disability Index, Neck Pain and Disability Scale, Visual Analogue Scale, and RAND will be filled with same day, by two observers and for the inter-observers assessment, with an interval of 45 minutes between the first and second application. Third assessment will be carried out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value. Test -retest reliability will be assessed using interclass correlation coefficient. The Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be evaluated for content validity, construct validity, criterion validity and responsiveness.
- Conditions
- Neck Pain
- Keywords
- Bournemouth Questionnaire For Neck Pain, Neck Pain, Cultural adaptation, Validity, Urdu Version, Reliability
- Medical subject headings
- Neck Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Bournemouth Questionnaire
Neck Bournemouth Questionnaire contain seven dimensions tool used for the investigation of pain,functional ability, activity, depression,anxiety, work avoidance due to fear and control of pain
Measured: 1st day
Neck Disability Index
The Neck Disability Index is most frequently used to evaluate pain in neck and neck pain related disability. One of previous study stated that the Neck Disability Index having multidisciplinary approach to disability
Measured: 1st day
Visual Analogue Scale
Visual Analogue Scale provides a continuous scale for subjective magnitude estimation and consists of a straight line, the limits of which carry a verbal description of each extreme of the symptom to be evaluated. The line is usually 10 cm long and vertical, though different lengths and orientations have been employed and proven satisfactory.
Measured: 1st day
Neck Pain and Disability Scale
The 20 items in the Neck Pain and Disability Scale measure the intensity of pain,its interference with the vocational,recreational,social, and functional aspects of living,and the presence and extent of associated emotional factors. The Neck Pain and Disability Scale is intended to be worded clearly and easy to complete.
Measured: 1st day
Rand 36-Item Health Survey
Scoring the Rand 36-Item Health Survey 1.0 is a two-step process. First, preceded numeric values are recorded per the scoring key. Note that all items are scored so that a high score defines a more favourable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
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 completion17 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 108 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
- NCT05221073
- Sponsor's protocol ID
- REC/FSD/0288
- 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
- Cross-cultural Adaptation and Psychometric Evaluation of the Bournemouth Questionnaire for Neck Pain
- ClinicalTrials.gov ID
- NCT05221073
- Acronym / sponsor ID
- REC/FSD/0288
- Conditions
- Neck Pain
- Keywords
- Bournemouth Questionnaire For Neck Pain, Neck Pain, Cultural adaptation, Validity, Urdu Version, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 28 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 study is to translate \& culturally adapt Neck Bournemouth Questionnaire into Urdu language along with investigation of the reliability \& validity of Neck Bournemouth Questionnaire in General Population of Pakistan and to correlate with Neck Disability Index, Visual Analogue Scale, Neck Pain and Disability Scale and Rand 36-Item Health Survey
Detailed description
The English version of the Bournemouth Questionnaire for Neck Pain will be translated and culturally adapted as per as previous recommendations. In the general population with neck pain, Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be distributed among participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. Test inter and intra- observer reliability of the final Urdu Version Of The Bournemouth Questionnaire For Neck Pain with Neck Disability Index, Neck Pain and Disability Scale, Visual Analogue Scale, and RAND will be filled with same day, by two observers and for the inter-observers assessment, with an interval of 45 minutes between the first and second application. Third assessment will be carried out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value. Test -retest reliability will be assessed using interclass correlation coefficient. The Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be evaluated for content validity, construct validity, criterion validity and responsiveness.
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
- General Population of Pakistan with Neck Pain was included in the study
Key inclusion criteria (8 listed)
- 18 to 65 years of age
- 3 months of neck pain
- Neck pain more than six moth
- Male female both genders
- Physician referral
Key exclusion criteria (11 listed)
- Joint inflammation or infection
- Pathology of shoulder
- Fibromylgia
- Psychologically unstable or having neurological disorder
- Cancer history
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
Neck Bournemouth Questionnaire
Time frame: 1st day
Neck Bournemouth Questionnaire contain seven dimensions tool used for the investigation of pain,functional ability, activity, depression,anxiety, work avoidance due to fear and control of pain
Neck Disability Index
Time frame: 1st day
The Neck Disability Index is most frequently used to evaluate pain in neck and neck pain related disability. One of previous study stated that the Neck Disability Index having multidisciplinary approach to disability
Visual Analogue Scale
Time frame: 1st day
Visual Analogue Scale provides a continuous scale for subjective magnitude estimation and consists of a straight line, the limits of which carry a verbal description of each extreme of the symptom to be evaluated. The line is usually 10 cm long and vertical, though different lengths and orientations have been employed and proven satisfactory.
Neck Pain and Disability Scale
Time frame: 1st day
The 20 items in the Neck Pain and Disability Scale measure the intensity of pain,its interference with the vocational,recreational,social, and functional aspects of living,and the presence and extent of associated emotional factors. The Neck Pain and Disability Scale is intended to be worded clearly and easy to complete.
Rand 36-Item Health Survey
Time frame: 1st day
Scoring the Rand 36-Item Health Survey 1.0 is a two-step process. First, preceded numeric values are recorded per the scoring key. Note that all items are scored so that a high score defines a more favourable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
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 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 8 inclusion and 11 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?
Neck Bournemouth Questionnaire (time frame: 1st day). The study lists 5 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.