Clinical trial NCT05300607: The Western Ontario Rotator Cuff Index Arabic Version
Official title: The Western Ontario Rotator Cuff Index Arabic Version: Cross-cultural Adaptation, Validity, and Reliability for Patients With Rotator Cuff Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surveys and Questionnaires
Rotator Cuff Injuries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with rotator cuff diseases from outpatient clinics

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Translation of western Ontario rotator cuff index questionnaire into Arabic for patients with rotator cuff injuries
timeFrame: 6 months
measure: Validation of Arabic version of The Western Ontario Rotator Cuff Index questionnaire for patients with rotator cuff injuries
timeFrame: 6 months
measure: Establishing the full psychometric properties of the Arabic version of the western Ontario rotator cuff index questionnaire for patients with rotator cuff injuries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy basic science department
Study officials:
affiliation: Cairo University
name: Yasser M. Aneis, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohsen El Sayyad, PHD
role: STUDY_CHAIR
References:
citation: 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.
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.