Rotator Cuff InjuriesNCT06635395
Turkish Validity and Reliability of Baltimore Orthopedic Subscapularis Score
An observational study of Rotator Cuff Injuries and Subscapularis Tendon Tear, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Injuries, Subscapularis Tendon Tear
- What is being tested?
- Scale validity and reliability
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 20 Feb 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with rotator cuff injury
Who may be able to join
- 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,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Cross-Cultural Adaptation of the Baltimore Orthopedic Subscapularis Score Into Turkish
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.
Read the 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.
- Conditions
- Rotator Cuff Injuries, Subscapularis Tendon Tear
- Being tested
- Scale validity and reliability
- Keywords
- scale validity, rotator cuff injuries, subscapularis tendon tear
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scale validity and reliabilityOther
The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish. It has 5 questions. The patients will be sought to answer questionnaires during regular rehabilitation sessions.
| Study group | Role | What they receive |
|---|---|---|
| patients with Rotator cuff injury | Scale validity and reliability The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish. It has 5 questions. The patients will be sought to answer questionnaires during regular rehabilitation sessions. Receives: Other: Scale validity and reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability will be assessed with the Baltimore Orthopedic Subscapularis Score (BOSS) in patients with rotator cuff injuries. It has 5 items. Each item is scored on a 1-to-5, a total score ranging from 5 (best possible score) to 25 (worst possible score). Higher scores indicate a higher disability.
Measured: baseline
Functionality of the shoulder
Functionality of the shoulder will be assessed with the Western Ontario Rotator Cuff Disability Index (WORC) in patients with rotator cuff injuries. It has 21 items. Each item is scored on a 0-to-100-mm visual analog scale, summing a total score ranging from 0 (best possible score) to 2100 (worst possible score). Higher scores indicate poorer functionality.
Measured: baseline
Secondary outcomes (1)
Health status
Health status will be assessed with the SF-12. It has 12 items. It has eight sub-dimensions and two summary scores: physical and mental. In the total score obtained from the scale, 100 indicates the best health status, while 0 indicates the worst health status.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2024
- Primary completion20 Nov 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
- Investigators
- emel mete, PhD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635395
- Sponsor's protocol ID
- BOSS
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Cross-Cultural Adaptation of the Baltimore Orthopedic Subscapularis Score Into Turkish
- ClinicalTrials.gov ID
- NCT06635395
- Acronym / sponsor ID
- BOSS
- Conditions
- Rotator Cuff Injuries, Subscapularis Tendon Tear
- Keywords
- scale validity, rotator cuff injuries, subscapularis tendon tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Rotator cuff injury | – | Other: Scale validity and reliabilityScale validity and reliability The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish. It has 5 questions. The patients will be sought to answer questionnaires during regular rehabilitation sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with rotator cuff injury
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scale validity and reliabilityThe aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish. It has 5 questions. The patients will be sought to answer questionnaires during regular rehabilitation sessions. | Other | patients with Rotator cuff injury |
Primary outcome
Disability
Time frame: baseline
Disability will be assessed with the Baltimore Orthopedic Subscapularis Score (BOSS) in patients with rotator cuff injuries. It has 5 items. Each item is scored on a 1-to-5, a total score ranging from 5 (best possible score) to 25 (worst possible score). Higher scores indicate a higher disability.
Functionality of the shoulder
Time frame: baseline
Functionality of the shoulder will be assessed with the Western Ontario Rotator Cuff Disability Index (WORC) in patients with rotator cuff injuries. It has 21 items. Each item is scored on a 0-to-100-mm visual analog scale, summing a total score ranging from 0 (best possible score) to 2100 (worst possible score). Higher scores indicate poorer functionality.
1 secondary outcome
Health status
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emel mete, PhD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries and Subscapularis Tendon Tear, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.