Urdu Version of Oxford Shoulder Score Scale: Reliability and Validity Study

Shoulder Pain Clinical Trial

Official title:

Evaluation of Reliability and Validity of Urdu Version of Oxford Shoulder Score Scale Among Pakistani Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432063
• Other study ID #: REC-FSD-00261
• Status: Recruiting
• Start date: May 30, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2022
• Source: Riphah International University
• Contact: Muhammad Kashif
• Phone: +92418777210
• Email: kashif.shaffi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years

• Documented cognitive impairment

• Patient with shoulder instability

• Acute traumatic shoulder injury

Exclusion Criteria:

• Age under 18 years

• Recent surgery

• Pain origination from neoplasms

• Systemic arthritic

Related Conditions & MeSH terms

• Shoulder Pain

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1st day
Primary	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).	1st day
Primary	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.	1st day