Rotator Cuff InjuriesNCT06630039
Turkish Validity and Reliability of Short-Western Ontario Rotator Cuff Disability Index
An observational study of Rotator Cuff Injuries, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to adapt the Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) to Turkish society and to make its validity and reliability in Turkish. The Western Ontario Rotator Cuff Disability Index (WORC) developed by Kirkley et al assesses quality of life in patients with Rotator Cuff… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Scale validity and reliability
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 30 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rotator cuff injury who are aged over 18 years
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 pain intensity > 2 according to the Visual Analog Scale,
- 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
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Medeniyet University
Istanbul, 34720
Istanbul Medeniyet University
Istanbul
About this study
Official title: Examination of the Validity and Reliability of the Short-Western Ontario Rotator Cuff Disability Index in Turkish in Patients With Rotator Cuff Injury
The aim of this study is to adapt the Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) to Turkish society and to make its validity and reliability in Turkish. The Western Ontario Rotator Cuff Disability Index (WORC) developed by Kirkley et al assesses quality of life in patients with Rotator Cuff İnjury. The WORC has 21 questions. The WORC was shortened and renamed as Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC). The SHORTWORC consists of 7 questions. This study will be conducted with patients with rotator cuff injuries. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 35 participants will be included in the study. In order to evaluate the validity of the SHORTWORC, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the quality of life in patients with rotator cuff injury and has been validated in Turkish, and the The University of California-Los Angeles (UCLA) shoulder scale, which can evaluate the functionality of shoulder 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 SHORTWORC will be able to be modified. The data of SHORTWORC are collecting through face-to-face when the patients came to the rehabilitation center. 35 participants will be included in the study.
In order to evaluate the validity of the SHORTWORC, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the quality of life in patients with rotator cuff injury and has been validated in Turkish, and the University of California-Los Angeles (UCLA) shoulder scale, which can evaluate the functionality of shoulder 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
- Being tested
- Scale validity and reliability
- Keywords
- roatator cuff injuries, scale validity, pain
- Medical subject headings
- Rotator Cuff Injuries, Pain
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 Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish. It has 7 questions. The patients will be sought to answer questionnaires during regular rehabilitation sessions.
| Study group | Role | What they receive |
|---|---|---|
| patients with Rotator cuff injury | Patients with roatator cuff injury who are aged over 18 years 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 Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) in patients with rotator cuff injury. It haf 7 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 700 (worst possible score). Higher scores indicate poorer quality of life.
Measured: baseline
Secondary outcomes (1)
Functionality of shoulder
Functionality of shoulder will be assessed with the University of California-Los Angeles (UCLA) shoulder scale. It contains a total of 5 questions belonging to 5 categories: Pain (scored from 1-10), Function (scored from 1-10), range of motion (scored from 0-5), muscle strength (scored from 0-5), patient satisfaction (scored from 0-5). Each category is scored differently. Higher scores indicate better shoulder functionality.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Oct 2024
- Primary completion20 Dec 2024
- Study completion30 Apr 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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630039
- Sponsor's protocol ID
- SHORTWORC
- Status last verified
- Aug 2025
- First submitted
- 4 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
- Examination of the Validity and Reliability of the Short-Western Ontario Rotator Cuff Disability Index in Turkish in Patients With Rotator Cuff Injury
- ClinicalTrials.gov ID
- NCT06630039
- Acronym / sponsor ID
- SHORTWORC
- Conditions
- Rotator Cuff Injuries
- Keywords
- roatator cuff injuries, scale validity, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 8 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 Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) to Turkish society and to make its validity and reliability in Turkish. The Western Ontario Rotator Cuff Disability Index (WORC) developed by Kirkley et al assesses quality of life in patients with Rotator Cuff İnjury. The WORC has 21 questions. The WORC was shortened and renamed as Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC). The SHORTWORC consists of 7 questions. This study will be conducted with patients with rotator cuff injuries. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 35 participants will be included in the study. In order to evaluate the validity of the SHORTWORC, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the quality of life in patients with rotator cuff injury and has been validated in Turkish, and the The University of California-Los Angeles (UCLA) shoulder scale, which can evaluate the functionality of shoulder 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 SHORTWORC will be able to be modified. The data of SHORTWORC are collecting through face-to-face when the patients came to the rehabilitation center. 35 participants will be included in the study.
In order to evaluate the validity of the SHORTWORC, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the quality of life in patients with rotator cuff injury and has been validated in Turkish, and the University of California-Los Angeles (UCLA) shoulder scale, which can evaluate the functionality of shoulder 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 reliabilityPatients with roatator cuff injury who are aged over 18 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rotator cuff injury who are aged over 18 years
Key inclusion criteria (4 listed)
- Individuals over 18 years of age who have been diagnosed with a rotator cuff injury,
- Patients whose native language is Turkish,
- Individuals with pain intensity > 2 according to the Visual Analog Scale,
- 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 Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish. It has 7 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 Short-Western Ontario Rotator Cuff Disability Index (SHORTWORC) in patients with rotator cuff injury. It haf 7 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 700 (worst possible score). Higher scores indicate poorer quality of life.
1 secondary outcome
Functionality of shoulder
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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, run by Istanbul Medeniyet University at 2 sites 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 4 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 2 sites 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). 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.