NCT06635395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

19 days

First QC Date

October 8, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

scale validityrotator cuff injuriessubscapularis tendon tear

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline

Secondary Outcomes (1)

  • Health status

    baseline

Study Arms (1)

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.

Other: Scale validity and reliability

Interventions

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.

patients with Rotator cuff injury

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with rotator cuff injury

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medeniyet University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • emel mete, PhD

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

November 1, 2024

Primary Completion

November 20, 2024

Study Completion

February 20, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations