Rotator Cuff InjuriesNCT06112444
Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index
An observational study of Rotator Cuff Injuries, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the psychometric properties of a Turkish shortened version of the Western Ontario Rotator Cuff Index (SHORTWORC). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- scale
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to Dec 2023
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: İndividuals diagnosed with Rotator cuff disease by a specialist in Gazi University Faculty of Medicine Orthopedics and Traumatology Polyclinic constitute the sample of the study.
Who may be able to join
- Between the ages of 18-64
- the presence of rotator cuff pathology requiring surgical treatment
Who cannot join
- Chronic inflammatory diseases
- cervical spine radiculopathy
- different structural shoulder problems in the last three months
- previous surgery and associated additional pathologies requiring stabilization or other major *surgery such as superior labral repair
- any history of systemic disease
- being an athlete
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, 06560
Selda BASAR, Prof, +905422926518, sbasar@gazi.edu.tr
About this study
The purpose of this study is to examine the psychometric properties of a Turkish shortened version of the Western Ontario Rotator Cuff Index (SHORTWORC).
Read the detailed description
Many of the musculoskeletal diseases that doctors treat every day affect both quality of life and functionality. Rotator Cuff diseases are highly prevalent shoulder disorders associated with pain and functional limitations. Thus, surveys measuring treatment outcomes and activity limitations have become important in clinical research. Such scales can be time consuming or impractical for the patient, depending on the areas they evaluate. For this reason, the development of scales focusing on specific areas facilitates evaluations in the clinical environment. The purpose of this study is to examine the psychometric properties the Turkish SHORTWORC index, which is designed to focus on a single parameter.
- Conditions
- Rotator Cuff Injuries
- Being tested
- scale
- Keywords
- validity of results, reliability of results
- 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.
scaleOther
The scale of Short Western Ontario Rotator Cuff İndex
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Western Ontario Rotator Cuff Index
The scale of Short Western Ontario Rotator Cuff Index is a disease-spesific index designed to evaluate activity limitations in patient with rotator cuff disorders. It is an abbreviated version of Western Ontario Rotator Cuff Index (WORC). İt has 7 items that access only 1 domain , the activity limitations. Patients rate their function on a scale from 0, meaning no difficulty, to 100, meaning extreme difficulty. The percentage scores for the Short-WORC are obtained by subtracting the total score from 700, dividing by 700, and multiplying by 100, resulting in a total percentage score varying from 0 to 100.,
Measured: First Day
Constant-Murley score (CMS)
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameter. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.
Measured: First Day
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. İt has been also reported to be reliable and valid in patients ,with upper extremity, shoulder or rotator cuff pathology.
Measured: First Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Sep 2023
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Başar, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112444
- Sponsor's protocol ID
- 2023-1070
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index
- ClinicalTrials.gov ID
- NCT06112444
- Acronym / sponsor ID
- 2023-1070
- Conditions
- Rotator Cuff Injuries
- Keywords
- validity of results, reliability of results
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Nov 2023 (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 purpose of this study is to examine the psychometric properties of a Turkish shortened version of the Western Ontario Rotator Cuff Index (SHORTWORC).
Detailed description
Many of the musculoskeletal diseases that doctors treat every day affect both quality of life and functionality. Rotator Cuff diseases are highly prevalent shoulder disorders associated with pain and functional limitations. Thus, surveys measuring treatment outcomes and activity limitations have become important in clinical research. Such scales can be time consuming or impractical for the patient, depending on the areas they evaluate. For this reason, the development of scales focusing on specific areas facilitates evaluations in the clinical environment. The purpose of this study is to examine the psychometric properties the Turkish SHORTWORC index, which is designed to focus on a single parameter.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- İndividuals diagnosed with Rotator cuff disease by a specialist in Gazi University Faculty of Medicine Orthopedics and Traumatology Polyclinic constitute the sample of the study.
Key inclusion criteria (2 listed)
- Between the ages of 18-64
- the presence of rotator cuff pathology requiring surgical treatment
Key exclusion criteria (6 listed)
- Chronic inflammatory diseases
- cervical spine radiculopathy
- different structural shoulder problems in the last three months
- previous surgery and associated additional pathologies requiring stabilization or other major *surgery such as superior labral repair
- any history of systemic disease
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 |
|---|---|---|
| scaleThe scale of Short Western Ontario Rotator Cuff İndex | Other | – |
Primary outcome
Short Western Ontario Rotator Cuff Index
Time frame: First Day
The scale of Short Western Ontario Rotator Cuff Index is a disease-spesific index designed to evaluate activity limitations in patient with rotator cuff disorders. It is an abbreviated version of Western Ontario Rotator Cuff Index (WORC). İt has 7 items that access only 1 domain , the activity limitations. Patients rate their function on a scale from 0, meaning no difficulty, to 100, meaning extreme difficulty. The percentage scores for the Short-WORC are obtained by subtracting the total score from 700, dividing by 700, and multiplying by 100, resulting in a total percentage score varying from 0 to 100.,
Constant-Murley score (CMS)
Time frame: First Day
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameter. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: First Day
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. İt has been also reported to be reliable and valid in patients ,with upper extremity, shoulder or rotator cuff pathology.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Injuries
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
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, run by Gazi 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selda BASAR, Prof. Dr (+90 5422926518, sbasar@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Western Ontario Rotator Cuff Index (time frame: First Day). The study lists 3 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 1 Nov 2023.