Shoulder PainNCT05432063
Urdu Version of Oxford Shoulder Score Scale: Reliability and Validity Study
An observational study of Shoulder Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The primary goal of this study is to translate and culturally adapt the Oxford Shoulder Score Scale into Urdu, as well as to assess its reliability and validity in the Urdu-speaking Pakistani community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 1 Jul 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: Pakistani general population with shoulder pain.
Who may be able to join
- Age above 18 years
- Documented cognitive impairment
- Patient with shoulder instability
- Acute traumatic shoulder injury
Who cannot join
- Age under 18 years
- Recent surgery
- Pain origination from neoplasms
- Systemic arthritic
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ripah International University
Faisalabad, Punjab Province, 38000
Muhammad Kashif, 0418777210, kashif.shaffi@gmail.com
About this study
Official title: Evaluation of Reliability and Validity of Urdu Version of Oxford Shoulder Score Scale Among Pakistani Population
The primary goal of this study is to translate and culturally adapt the Oxford Shoulder Score Scale into Urdu, as well as to assess its reliability and validity in the Urdu-speaking Pakistani community. This research will also look at the relationship between Oxford Shoulder Score Scale and the Shoulder Pain And Disability Index and Short Form - 36 scores for shoulder pain.
Read the detailed description
The English version of the Oxford Shoulder Score Scale will be translated and culturally modified into Urdu. The Oxford Shoulder Score Scale, as well as other correlation measures, will be disseminated among 104 individuals in the Pakistani Urdu speaking community, who will be chosen using a convenience sample approach and based on pre-defined inclusion and exclusion criteria. For the intra- and inter-observer validity and reliability of the Oxford Shoulder Score Scale, Shoulder Pain And Disability Index, and Short Form - 36, questionnaires will be filled on the same day by two observers, with a two-hour gap between the first and second application. This is the inter-observer evaluation. The third application for the intra-observer evaluation will be completed after 7 days. Statistical Package of Social Sciences Version 26 will be used to enter and analyses the data. The internal consistency will be assessed using the Cronbach alpha value. The test-retest reliability will be assessed using an inter-class correlation coefficient. The content validity, criteria and construct validity, as well as responsiveness, of the Oxford Shoulder Score Scale scale will be assessed.
- Conditions
- Shoulder Pain
- Keywords
- Oxford Shoulder Score Scale, Urdu Version, Reliability, Validity, Shoulder Pain
- Medical subject headings
- Shoulder Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score Scale
The OSS is a 12-item questionnaire that patients with a degenerative or inflammatory shoulder disease must complete. Each question includes five response options, each with a score range from 0 to 4. The overall score runs from 0 to 48 (worst to greatest).
Measured: 1st day
Shoulder Pain And Disability Index
The Shoulder Pain And Disability Index is a self-report questionnaire that evaluates pain and impairment in the shoulder. It is made up of 13 items divided into two subscales: pain (5 items) and disability (5 items) (8 items). Both subscales' items are rated on a scale of 0 to 10 (no pain or impairment) (the worst imaginable pain or so much difficulty on performing tasks that help is required).
Measured: 1st day
Short Form - 36
The SF-36 is a 36-question Health Related Quality of Life survey divided into eight sections: vitality, physical functioning, bodily pain, general health, physical role functioning, emotional role functioning, social role functioning, and mental health. Each component of the questionnaire can be given a score ranging from 0 to 100. The lower the score, the lower the quality of life for the subject.
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 posted27 Jun 2022
- Study start30 May 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- 105 participants (estimated)
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
- NCT05432063
- Sponsor's protocol ID
- REC-FSD-00261
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 27 Jun 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 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reliability and Validity of Urdu Version of Oxford Shoulder Score Scale Among Pakistani Population
- ClinicalTrials.gov ID
- NCT05432063
- Acronym / sponsor ID
- REC-FSD-00261
- Conditions
- Shoulder Pain
- Keywords
- Oxford Shoulder Score Scale, Urdu Version, Reliability, Validity, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 27 Jun 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 primary goal of this study is to translate and culturally adapt the Oxford Shoulder Score Scale into Urdu, as well as to assess its reliability and validity in the Urdu-speaking Pakistani community. This research will also look at the relationship between Oxford Shoulder Score Scale and the Shoulder Pain And Disability Index and Short Form - 36 scores for shoulder pain.
Detailed description
The English version of the Oxford Shoulder Score Scale will be translated and culturally modified into Urdu. The Oxford Shoulder Score Scale, as well as other correlation measures, will be disseminated among 104 individuals in the Pakistani Urdu speaking community, who will be chosen using a convenience sample approach and based on pre-defined inclusion and exclusion criteria. For the intra- and inter-observer validity and reliability of the Oxford Shoulder Score Scale, Shoulder Pain And Disability Index, and Short Form - 36, questionnaires will be filled on the same day by two observers, with a two-hour gap between the first and second application. This is the inter-observer evaluation. The third application for the intra-observer evaluation will be completed after 7 days. Statistical Package of Social Sciences Version 26 will be used to enter and analyses the data. The internal consistency will be assessed using the Cronbach alpha value. The test-retest reliability will be assessed using an inter-class correlation coefficient. The content validity, criteria and construct validity, as well as responsiveness, of the Oxford Shoulder Score Scale scale will be assessed.
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
- Pakistani general population with shoulder pain.
Key inclusion criteria (4 listed)
- Age above 18 years
- Documented cognitive impairment
- Patient with shoulder instability
- Acute traumatic shoulder injury
Key exclusion criteria (4 listed)
- Age under 18 years
- Recent surgery
- Pain origination from neoplasms
- Systemic arthritic
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
Oxford Shoulder Score Scale
Time frame: 1st day
The OSS is a 12-item questionnaire that patients with a degenerative or inflammatory shoulder disease must complete. Each question includes five response options, each with a score range from 0 to 4. The overall score runs from 0 to 48 (worst to greatest).
Shoulder Pain And Disability Index
Time frame: 1st day
The Shoulder Pain And Disability Index is a self-report questionnaire that evaluates pain and impairment in the shoulder. It is made up of 13 items divided into two subscales: pain (5 items) and disability (5 items) (8 items). Both subscales' items are rated on a scale of 0 to 10 (no pain or impairment) (the worst imaginable pain or so much difficulty on performing tasks that help is required).
Short Form - 36
Time frame: 1st day
The SF-36 is a 36-question Health Related Quality of Life survey divided into eight sections: vitality, physical functioning, bodily pain, general health, physical role functioning, emotional role functioning, social role functioning, and mental health. Each component of the questionnaire can be given a score ranging from 0 to 100. The lower the score, the lower the quality of life for the subject.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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 Shoulder 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Kashif (+92418777210, kashif.shaffi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score Scale (time frame: 1st day). The study lists 3 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 27 Jun 2022.