Rotator Cuff DiseaseNCT06677320
Establishing Clinical Significance in Rotator Cuff Disease
An observational study of Rotator Cuff Disease, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about rotator cuff patients. The main questions it aims to answer are: What is the minimal clinically important difference value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Disease
- What is being tested?
- Exercise
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted with rotator cuff patients who will have physical therapy at Kırklareli Training and Research Hospital's physical therapy unit.
Who may be able to join
- to be over 18 years old
- to be a rotator cuff patient
Who cannot join
- to have another pathology in the affected shoulder area
- to have a neurological, rheumatological, or oncological disease
- to have radiculopathy
- to have had a previous fracture or operation in the affected shoulder area
- to be not cooperative enough for what will be done within the scope of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırklareli Eğitim ve Araştırma Hastanesi
Kırklareli, 39000
About this study
Official title: Establishing the Clinical Significance Values of Scales Used in Rotator Cuff Disease
The goal of this observational study is to learn about rotator cuff patients. The main questions it aims to answer are:
- What is the minimal clinically important difference value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What is the substantial clinical benefit value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What is the patient-acceptable symptomatic state value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What is the maximal outcome improvement value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What are the risk factors that prevent rotator cuff patients from reaching the minimal clinically important difference value?
- What are the risk factors that prevent rotator cuff patients from reaching the substantial clinical benefit value?
- What are the risk factors that prevent rotator cuff patients from reaching the patient-acceptable symptomatic state value?
- What are the risk factors that prevent rotator cuff patients from reaching the maximal outcome improvement value?
- Conditions
- Rotator Cuff Disease
- Being tested
- Exercise
- Keywords
- rotator cuff, clinical significance, minimal important chance, substantial clinical benefit, patient acceptable symptomatic state, maximal outcome improvement, Shoulder Disability Questionnaire, Western Ontario Rotator Cuff Index, Shoulder Rating Questionnaire, University of California-Los Angeles Shoulder Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Patients with rotator cuff disease will receive exercise treatment for two months.
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff patients | Patients with rotator cuff disease who will receive conservative treatment. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional level
Shoulder Disability Questionnaire (total score between 0-100) (higher values indicate higher disability)
Measured: before the treatment and within 1 week after 2 months of treatment
Functional level
The short version of the Western Ontario Rotator Cuff Index (total score between 0-100) (higher values indicate higher functional level)
Measured: before the treatment and within 1 week after 2 months of treatment
Functional level
Shoulder Rating Questionnaire (total score between 17-100) (higher values indicate higher functional level)
Measured: before the treatment and within 1 week after 2 months of treatment
Functional level
The University of California-Los Angeles Shoulder Scale (total score between 0-100) (higher values indicate higher functional level)
Measured: before the treatment and within 1 week after 2 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start3 Mar 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Gür, PT, Kırklareli University
- Investigators
- Ozan Gür, MSc, Principal investigator, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677320
- Sponsor's protocol ID
- 2024-1636
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Clinical Significance Values of Scales Used in Rotator Cuff Disease
- ClinicalTrials.gov ID
- NCT06677320
- Acronym / sponsor ID
- 2024-1636
- Conditions
- Rotator Cuff Disease
- Keywords
- rotator cuff, clinical significance, minimal important chance, substantial clinical benefit, patient acceptable symptomatic state, maximal outcome improvement, Shoulder Disability Questionnaire, Western Ontario Rotator Cuff Index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Nov 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 goal of this observational study is to learn about rotator cuff patients. The main questions it aims to answer are:
- What is the minimal clinically important difference value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What is the substantial clinical benefit value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What is the patient-acceptable symptomatic state value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What is the maximal outcome improvement value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
- What are the risk factors that prevent rotator cuff patients from reaching the minimal clinically important difference value?
- What are the risk factors that prevent rotator cuff patients from reaching the substantial clinical benefit value?
- What are the risk factors that prevent rotator cuff patients from reaching the patient-acceptable symptomatic state value?
- What are the risk factors that prevent rotator cuff patients from reaching the maximal outcome improvement value?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff patients | – | Other: ExercisePatients with rotator cuff disease who will receive conservative treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted with rotator cuff patients who will have physical therapy at Kırklareli Training and Research Hospital's physical therapy unit.
Key inclusion criteria (2 listed)
- to be over 18 years old
- to be a rotator cuff patient
Key exclusion criteria (5 listed)
- to have another pathology in the affected shoulder area
- to have a neurological, rheumatological, or oncological disease
- to have radiculopathy
- to have had a previous fracture or operation in the affected shoulder area
- to be not cooperative enough for what will be done within the scope of the study
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 |
|---|---|---|
| ExercisePatients with rotator cuff disease will receive exercise treatment for two months. | Other | Rotator cuff patients |
Primary outcome
Functional level
Time frame: before the treatment and within 1 week after 2 months of treatment
Shoulder Disability Questionnaire (total score between 0-100) (higher values indicate higher disability)
Functional level
Time frame: before the treatment and within 1 week after 2 months of treatment
The short version of the Western Ontario Rotator Cuff Index (total score between 0-100) (higher values indicate higher functional level)
Functional level
Time frame: before the treatment and within 1 week after 2 months of treatment
Shoulder Rating Questionnaire (total score between 17-100) (higher values indicate higher functional level)
Functional level
Time frame: before the treatment and within 1 week after 2 months of treatment
The University of California-Los Angeles Shoulder Scale (total score between 0-100) (higher values indicate higher functional level)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Disease
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E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
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Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, and Function
Shoulder Pain and Stiffness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
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.
Ozan Gür, MSc principal investigator
Kırklareli 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 Disease, run by Kırklareli 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 5 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ozan Gür, MSc (506 338 38 49 ext. 90, ozan.gur94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional level (time frame: before the treatment and within 1 week after 2 months of treatment). The study lists 4 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 13 Aug 2026.