Surveys and QuestionnairesNCT05300607
The Western Ontario Rotator Cuff Index Arabic Version
An observational study of Surveys and Questionnaires and Rotator Cuff Injuries, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate, translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index (WORC). The null hypothesis of this study will be stated as: Arabic language version of the WORC doesn't have face, content, or construct validity enough to measure quality of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surveys and Questionnaires, Rotator Cuff Injuries
- What is being tested?
- Cross-cultural adaptation, validity, and reliability
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 2 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with rotator cuff diseases from outpatient clinics
Who may be able to join
- Referred with rotator cuff tendinopathy or rotator cuff partial tear by physician.
- Able to read and write in Arabic.
- Their age will be Between 18 to 60 years old
- patients with chronic inflammatory diseases will be included
Who cannot join
- Patients with impairments in the cervical spine, elbow, or hand affecting the shoulder function
- Patients that have Cognitive alterations
- Patients that have any systemic disease that may affect patient's outcome.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy basic science department
Cairo, 11511
Yasser M. Aneis, PHD, 01001743830, dryassercom@yahoo.com
About this study
Official title: The Western Ontario Rotator Cuff Index Arabic Version: Cross-cultural Adaptation, Validity, and Reliability for Patients With Rotator Cuff Disease
To evaluate, translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index (WORC).
The null hypothesis of this study will be stated as:
Arabic language version of the WORC doesn't have face, content, or construct validity enough to measure quality of life related to rotator cuff disorders in Arabic patients.
Arabic language version of the WORC doesn't have reliability to measure quality of life related to rotator cuff disorders in Arabic patients
Read the detailed description
The WORC is an increasingly applied outcome measure for rotator cuff conditions. The WORC is a self-assessment scale that was developed to measure the quality of life of patients with RC disorders. It contains 21 items representing 5 subscales: physical symptoms 6 items, sports/recreation 4 items, work 4 items, lifestyle 4 items, and emotions 3 items, which encompass all aspects of heath as defined by the World Health Organization.
It has been translated and validated in several languages, including Chinese, Dutch, French-Canadian, Japanese, Norwegian, Persian, Polish, Portuguese - Brazilian, Spanish, Swedish and Turkish.
The current studies point out the increasing need for a questionnaire specifically developed to measure health related quality of life in patients treated conservatively, and respecting the following main characteristics: presenting adequate measurement properties and allowing to make comparisons of health-related quality of life between patients.
Cross-cultural adaptation allows globalization of information worldwide without the loss of the conceptual meaning. This enables the exchange and comparisons of valid information among different populations worldwide.
The Western Ontario Rotator Cuff Index has not been translated into the Arabic language, so it has a limited use in Egypt as well as Arabic countries. Therefore, the aim of this study is to translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index.
- Conditions
- Surveys and Questionnaires, Rotator Cuff Injuries
- Being tested
- Cross-cultural adaptation, validity, and reliability
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-cultural adaptation, validity, and reliabilityOther
evaluation, translation, cultural adaption, validation, and investigation of the reliability of Arabic version of The Western Ontario Rotator Cuff Index (WORC) to be used in Arabic countries.
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | rotator cuff diseases patients will self report the items of the Arabic version of The Western Ontario Rotator Cuff Index questionnaire Receives: Other: Cross-cultural adaptation, validity, and reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation of western Ontario rotator cuff index questionnaire into Arabic for patients with rotator cuff injuries
It will be performed according to the guidelines of Sousa. First forward translation of the questionnaire from English to Arabic producing two forward-translated versions of the questionnaire then the instructions, the items and the response format of the forward-translated versions are compared for any discrepancies that must be discussed and resolved using expert committee. then the translated Arabic version will be Back-translated to English producing two back-translated versions. then the instructions, items, and response format of both the two back-translations and the original questionnaire are compared by expert committee regarding format, grammatical structure, similarity in meaning, and relevance to derive a pre-final version of the questionnaire in Arabic. This version is pilot tested among participants whose language is Arabic to evaluate questionnaire for clarity. Participants should be recruited from the target population of the questionnaire
Measured: 6 months
Validation of Arabic version of The Western Ontario Rotator Cuff Index questionnaire for patients with rotator cuff injuries
The Disabilities of the Arm, Shoulder and Hand questionnaire and The Short Form 36 questionnaire will be used for the validity process to establish correlation between the subscales of Western Ontario Rotator Cuff Index questionnaire and the subscales of The Disabilities of the Arm, Shoulder and Hand questionnaire and The Short Form 36 questionnaire which has already been translated and validated in its Arabic version.
Concurrent validity will be evaluated by comparing Western Ontario Rotator Cuff Index questionnaire domains with relevant domains in The Disabilities of the Arm, Shoulder and Hand questionnaire and The Short Form 36 questionnaire The western Ontario rotator cuff index questionnaire consists of 21 items Each item is answered on a 100 - mm visual analog scale. 0 is minimum score and 100 is maximum score. The scores of 21 items are added to give a total score from 0 to 2100.The highest or most symptomatic score is 2100, and the best or asymptomatic score is 0
Measured: 6 months
Establishing the full psychometric properties of the Arabic version of the western Ontario rotator cuff index questionnaire for patients with rotator cuff injuries
The questionnaire has 21 items with 5 domains: physical symptoms(6 items), sport(4 items), work(4 items), lifestyle(4 items), and emotional(3 items). It has instructions to the patients and a supplement with an explanation of each item. Each item is answered on a 100 - mm visual analog scale, 0 is minimum and 100 is maximum score. The scores of 21 items are added to give a total from 0 to 2100.The highest or most symptomatic score is 2100, and the best or asymptomatic score is 0. 200 patients with rotator cuff injuries will participate. Patients will fill out the Arabic version of western Ontario rotator cuff index questionnaire along with the Arabic version of both the Short Form 36 questionnaire and Disabilities, of the Arm, Shoulder, and Hand questionnaire and 1 week later, the patient will refill out the 3 questionnaires. the short form 36, Disabilities, of the Arm, Shoulder, and Hand and the western Ontario rotator cuff index questionnaires contain similar subscales.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Feb 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion2 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surveys and QuestionnairesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Nasser Zaki, Cairo University
- Investigators
- Yasser M. Aneis, PHD, Study director, Cairo UniversityMohsen El Sayyad, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300607
- Sponsor's protocol ID
- P.T.REC/012/003550
- Status last verified
- Aug 2024
- First submitted
- 5 Feb 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing the results and the Arabic version of the questionnaire to be available to be used with rotator cuff diseases patients in Arabic countries
Publications
Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003 Mar;13(2):84-92. doi: 10.1097/00042752-200303000-00004.
PubMed 12629425Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
PubMed 20874835
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Western Ontario Rotator Cuff Index Arabic Version: Cross-cultural Adaptation, Validity, and Reliability for Patients With Rotator Cuff Disease
- ClinicalTrials.gov ID
- NCT05300607
- Acronym / sponsor ID
- P.T.REC/012/003550
- Conditions
- Surveys and Questionnaires, Rotator Cuff Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 2 Dec 2024 (estimated)
- First posted
- 29 Mar 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.
To evaluate, translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index (WORC).
The null hypothesis of this study will be stated as:
Arabic language version of the WORC doesn't have face, content, or construct validity enough to measure quality of life related to rotator cuff disorders in Arabic patients.
Arabic language version of the WORC doesn't have reliability to measure quality of life related to rotator cuff disorders in Arabic patients
Detailed description
The WORC is an increasingly applied outcome measure for rotator cuff conditions. The WORC is a self-assessment scale that was developed to measure the quality of life of patients with RC disorders. It contains 21 items representing 5 subscales: physical symptoms 6 items, sports/recreation 4 items, work 4 items, lifestyle 4 items, and emotions 3 items, which encompass all aspects of heath as defined by the World Health Organization.
It has been translated and validated in several languages, including Chinese, Dutch, French-Canadian, Japanese, Norwegian, Persian, Polish, Portuguese - Brazilian, Spanish, Swedish and Turkish.
The current studies point out the increasing need for a questionnaire specifically developed to measure health related quality of life in patients treated conservatively, and respecting the following main characteristics: presenting adequate measurement properties and allowing to make comparisons of health-related quality of life between patients.
Cross-cultural adaptation allows globalization of information worldwide without the loss of the conceptual meaning. This enables the exchange and comparisons of valid information among different populations worldwide.
The Western Ontario Rotator Cuff Index has not been translated into the Arabic language, so it has a limited use in Egypt as well as Arabic countries. Therefore, the aim of this study is to translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | – | Other: Cross-cultural adaptation, validity, and reliabilityrotator cuff diseases patients will self report the items of the Arabic version of The Western Ontario Rotator Cuff Index questionnaire |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with rotator cuff diseases from outpatient clinics
Key inclusion criteria (4 listed)
- Referred with rotator cuff tendinopathy or rotator cuff partial tear by physician.
- Able to read and write in Arabic.
- Their age will be Between 18 to 60 years old
- patients with chronic inflammatory diseases will be included
Key exclusion criteria (3 listed)
- Patients with impairments in the cervical spine, elbow, or hand affecting the shoulder function
- Patients that have Cognitive alterations
- Patients that have any systemic disease that may affect patient's outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-cultural adaptation, validity, and reliabilityevaluation, translation, cultural adaption, validation, and investigation of the reliability of Arabic version of The Western Ontario Rotator Cuff Index (WORC) to be used in Arabic countries. | Other | questionnaire |
Primary outcome
Translation of western Ontario rotator cuff index questionnaire into Arabic for patients with rotator cuff injuries
Time frame: 6 months
It will be performed according to the guidelines of Sousa. First forward translation of the questionnaire from English to Arabic producing two forward-translated versions of the questionnaire then the instructions, the items and the response format of the forward-translated versions are compared for any discrepancies that must be discussed and resolved using expert committee. then the translated Arabic version will be Back-translated to English producing two back-translated versions. then the instructions, items, and response format of both the two back-translations and the original questionnaire are compared by expert committee regarding format, grammatical structure, similarity in meaning, and relevance to derive a pre-final version of the questionnaire in Arabic. This version is pilot tested among participants whose language is Arabic to evaluate questionnaire for clarity. Participants should be recruited from the target population of the questionnaire
Validation of Arabic version of The Western Ontario Rotator Cuff Index questionnaire for patients with rotator cuff injuries
Time frame: 6 months
The Disabilities of the Arm, Shoulder and Hand questionnaire and The Short Form 36 questionnaire will be used for the validity process to establish correlation between the subscales of Western Ontario Rotator Cuff Index questionnaire and the subscales of The Disabilities of the Arm, Shoulder and Hand questionnaire and The Short Form 36 questionnaire which has already been translated and validated in its Arabic version. Concurrent validity will be evaluated by comparing Western Ontario Rotator Cuff Index questionnaire domains with relevant domains in The Disabilities of the Arm, Shoulder and Hand questionnaire and The Short Form 36 questionnaire The western Ontario rotator cuff index questionnaire consists of 21 items Each item is answered on a 100 - mm visual analog scale. 0 is minimum score and 100 is maximum score. The scores of 21 items are added to give a total score from 0 to 2100.The highest or most symptomatic score is 2100, and the best or asymptomatic score is 0
Establishing the full psychometric properties of the Arabic version of the western Ontario rotator cuff index questionnaire for patients with rotator cuff injuries
Time frame: 6 months
The questionnaire has 21 items with 5 domains: physical symptoms(6 items), sport(4 items), work(4 items), lifestyle(4 items), and emotional(3 items). It has instructions to the patients and a supplement with an explanation of each item. Each item is answered on a 100 - mm visual analog scale, 0 is minimum and 100 is maximum score. The scores of 21 items are added to give a total from 0 to 2100.The highest or most symptomatic score is 2100, and the best or asymptomatic score is 0. 200 patients with rotator cuff injuries will participate. Patients will fill out the Arabic version of western Ontario rotator cuff index questionnaire along with the Arabic version of both the Short Form 36 questionnaire and Disabilities, of the Arm, Shoulder, and Hand questionnaire and 1 week later, the patient will refill out the 3 questionnaires. the short form 36, Disabilities, of the Arm, Shoulder, and Hand and the western Ontario rotator cuff index questionnaires contain similar subscales.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 12629425Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003 Mar;13(2):84-92. doi: 10.1097/00042752-200303000-00004.
- Background: PubMed 20874835Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
- Individual participant dataSharing planned: Yes. sharing the results and the Arabic version of the questionnaire to be available to be used with rotator cuff diseases patients in Arabic countries
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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.
Yasser M. Aneis, PHD study director
Cairo University
Mohsen El Sayyad, PHD study chair
Cairo 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 Surveys and Questionnaires and Rotator Cuff Injuries, run by Cairo University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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 Egypt. 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 lydia zaki, Bachelor (01227076695, lydianasserzaki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation of western Ontario rotator cuff index questionnaire into Arabic for patients with rotator cuff injuries (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05300607, which also lists 2 linked publications.
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 26 Aug 2024.