The Western Ontario Rotator Cuff Index Arabic Version

Rotator Cuff Injuries Clinical Trial

Official title:

The Western Ontario Rotator Cuff Index Arabic Version: Cross-cultural Adaptation, Validity, and Reliability for Patients With Rotator Cuff Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300607
• Other study ID #: P.T.REC/012/003550
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: June 2, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: lydia zaki, Bachelor
• Phone: 01227076695
• Email: lydianasserzaki[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Surveys and Questionnaires

Intervention

Other:
• Cross-cultural adaptation, validity, and reliability
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.

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy basic science department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

Sousa 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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.	6 months