The Western Ontario Rotator Cuff Index Arabic Version

NCT05300607 | Recruiting

• 1 other identifier: P.T.REC/012/003550
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Surveys and Questionnaires; Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

questionnaire

rotator cuff diseases patients will self report the items of the Arabic version of The Western Ontario Rotator Cuff Index questionnaire

Other: Cross-cultural adaptation, validity, and reliability

Interventions

Cross-cultural adaptation, validity, and reliability OTHER

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.

questionnaire

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

patients with rotator cuff diseases from outpatient clinics

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy basic science department

Cairo, 11511, Egypt

RECRUITING

Related 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.

  PMID: 12629425 BACKGROUND

• 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.

  PMID: 20874835 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Yasser M. Aneis, PHD

  Cairo University

  STUDY DIRECTOR

• Mohsen El Sayyad, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

lydia zaki, Bachelor

CONTACT

01227076695; lydianasserzaki@gmail.com

somia farid, bachelor

CONTACT

01223786482; somia_farid@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: March 29, 2022
• Study Start: February 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: December 2, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: the Arabic version will be shared with Arabic countries medical stuff who tend to measure the quality of life of patients with rotator cuff diseases

Locations

EG (1)