Clinical trial NCT06635395: Turkish Validity and Reliability of Baltimore Orthopedic Subscapularis Score
Official title: Translation and Cross-Cultural Adaptation of the Baltimore Orthopedic Subscapularis Score Into Turkish
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rotator Cuff Injuries
Subscapularis Tendon Tear
Keywords: scale validity
rotator cuff injuries
subscapularis tendon tear
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with rotator cuff injury

Brief summary: The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society and to make its validity and reliability in Turkish. The BOSS was developed by Hameker et al to differentiate subscapularis tears from other rotator cuff muscle tears in patients with rotator cuff injuries. The BOSS has 5 questions. This study will be conducted with patients with rotator cuff injuries. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 25 participants will be included in the study. In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of the shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Detailed description: The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.

The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of BOSS will be able to be modified. The data of BOSS will be collecting through face-to-face when the patients came to the rehabilitation center. 25 participants will be included in the study.

In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria: Inclusion Criteria:

* Individuals over 18 years of age who have been diagnosed with a rotator cuff injury,
* Patients whose native language is Turkish,
* Individuals with a Mini Mental State Examination score of \>24,

Exclusion Criteria:

* Individuals with pain and disability due to any shoulder pathology other than rotator cuff injury,
* Individuals who cannot read or write Turkish,
* Individuals with shoulder fractures, surgical interventions and other accompanying shoulder pathologies,

Primary outcomes:
measure: Disability
timeFrame: baseline
measure: Functionality of the shoulder
timeFrame: baseline
Secondary outcomes:
measure: Health status
timeFrame: baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
affiliation: Istanbul Medeniyet University
name: emel mete, PhD
role: PRINCIPAL_INVESTIGATOR
References: