Rotator Cuff TearsNCT07183774
Does Sarcopenia Influence Rotator Cuff Tear Patterns? Radiological Insights From Patients With Rotator Cuff Syndrome
An observational study of Rotator Cuff Tears and Sarcopenia, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sarcopenia is the loss of muscle mass due to aging, which consequently leads to a decline in muscle function. It is considered an independent risk factor for falls and fractures, disability, postoperative complications, and mortality. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rotator Cuff Tears, Sarcopenia, Shoulder Pain
- What is being tested?
- Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Dec 2025
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study's target population will be patients aged 40 to 75 who have experienced shoulder pain for longer than three months and who have been physically evaluated and found to have rotator cuff syndrome.
Who may be able to join
- Patients with rotator cuff syndrome
- Aged between 40 and 75 years
Who cannot join
- History of previous shoulder surgery
- Presence of shoulder pathology other than rotator cuff syndrome
- History of surgical intervention involving the hip or thigh region
- Being wheelchair-bound or bedridden
- Presence of an oncologic disease
- Diagnosis of any neurological disorder
- Presence of cognitive impairment
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
Health Science University Haydarpaşa Numune Research and Training Hospital
Istanbul, Üsküdar, 34668
About this study
Sarcopenia is the loss of muscle mass due to aging, which consequently leads to a decline in muscle function. It is considered an independent risk factor for falls and fractures, disability, postoperative complications, and mortality. Rotator cuff tears are known to be influenced by systemic diseases such as diabetes, hypercholesterolemia, thyroid disorders, and osteoporosis. The aim of our study is to investigate whether there is a relationship between sarcopenia and rotator cuff tears, and if so, to determine the location and type of the tear.
Read the detailed description
Patients aged between 40 and 75 years who present to the Physical Medicine and Rehabilitation Department's Shoulder Outpatient Clinic with shoulder pain lasting for at least three months, have undergone shoulder MRI as part of their diagnostic work-up, and have been clinically diagnosed with rotator cuff syndrome based on physical examination, will be included in the study.
Demographic data of the patients will be recorded. A detailed history regarding shoulder pain will be obtained. Pain severity will be assessed using the Visual Analog Scale (VAS), and shoulder functional impairment will be evaluated using the Shoulder Disability Questionnaire.
Following the clinical assessment of shoulder pain, sarcopenia evaluation will be performed by a different physician who is blinded to the patients' imaging and clinical findings. Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.
In this method, gait speed, handgrip strength (measured with a dynamometer), and the chair stand test will first be conducted. For gait speed, a 6-meter walking track will be used, and patients will be instructed to walk at their normal pace. The time will be recorded with a stopwatch, and each patient will perform the test three times, with the average recorded in meters per second (m/s).
In the chair stand test, the patient will be asked to rise from a chair five times as quickly as possible without using their arms, keeping both hands crossed over the chest (opposite shoulders). The time taken will be recorded with a stopwatch.
Handgrip strength will be measured using a Jamar dynamometer, with the shoulder in adduction, elbow at 90° flexion, and the wrist and hand in a neutral position. The patient will repeat the test three times, and the highest value will be recorded.
Patients will then be evaluated based on whether their gait speed is below 1.0 m/s, grip strength is 2 standard deviations below the norm, or chair stand time is ≥12 seconds.
Subsequently, anterior thigh muscle thickness will be measured using ultrasonography. Based on this comprehensive evaluation, patients will be categorized as non-sarcopenic, pre-sarcopenic, or sarcopenic.
At the end of the study, the shoulder MRIs of patients in each of these three categories will be analyzed to assess the presence, type, and severity of rotator cuff tears. This study aims to determine whether sarcopenia predisposes individuals to rotator cuff tears and, if so, what type of tear is more likely to occur in sarcopenic patients.
- Conditions
- Rotator Cuff Tears, Sarcopenia, Shoulder Pain, Rotator Cuff Syndrome
- Being tested
- Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.
- Keywords
- Rotator cuff syndrome, Rotator cuff tear, Sarcopenia
- Medical subject headings
- Rotator Cuff Injuries, Sarcopenia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.Diagnostic test
Also called Shoulder MRIs of patients in each of these three categories will be analyzed to assess the presence, type, and severity of rotator cuff tears.
A detailed evaluation of shoulder MRI scans will be conducted. The presence and severity of supraspinatus tendon tears, as well as the presence of muscle atrophy (assessed using the tangent sign), will be recorded. In addition, tears in other rotator cuff tendons, signs of tendinitis, and any other pathological findings will also be documented.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rotator cuff tear | Patients with parsiyel or full thickness rotator cuff tear in supraspinatus tendon Receives: Diagnostic Test: Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method. | |
| Patients without rotator cuff tear | Patients without tear in supraspnatus tendon Receives: Diagnostic Test: Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAR value
Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.
In this method, gait speed, handgrip strength (measured with a dynamometer), and the chair stand test will first be conducted. For gait speed, a 6-meter walking track will be used, and patients will be instructed to walk at their normal pace. The time will be recorded with a stopwatch, and each patient will perform the test three times, with the average recorded in meters per second (m/s).
Subsequently, anterior thigh muscle thickness will be measured using ultrasonography. Based on this comprehensive evaluation, patients will be categorized as non-sarcopenic, pre-sarcopenic, or sarcopenic.
Measured: Baseline
Secondary outcomes (1)
Radiologic evaluation of shoulder MRI
Shoulder MRIs of patients in each of these three categories will be analyzed to assess the presence, type, and severity of rotator cuff tears.
A detailed evaluation of shoulder MRI scans will be conducted. The presence and severity of supraspinatus tendon tears, as well as the presence of muscle atrophy (assessed using the tangent sign), will be recorded. In addition, tears in other rotator cuff tendons, signs of tendinitis, and any other pathological findings will also be documented.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel süzen Özbayrak, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183774
- Sponsor's protocol ID
- HNEAH-BAEK 2024/123
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Atala NA, Bongiovanni SL, Galich AM, Bruchmann MG, Rossi LA, Tanoira I, Ranalletta M. Is sarcopenia a risk factor for rotator cuff tears? J Shoulder Elbow Surg. 2021 Aug;30(8):1851-1855. doi: 10.1016/j.jse.2020.10.001. Epub 2020 Nov 4.
PubMed 33157241Chung SW, Yoon JP, Oh KS, Kim HS, Kim YG, Lee HJ, Jeong WJ, Kim DH, Lee JS, Yoon JW. Rotator cuff tear and sarcopenia: are these related? J Shoulder Elbow Surg. 2016 Sep;25(9):e249-55. doi: 10.1016/j.jse.2016.02.008. Epub 2016 Apr 12.
PubMed 27083579Han DS, Wu WT, Hsu PC, Chang HC, Huang KC, Chang KV. Sarcopenia Is Associated With Increased Risks of Rotator Cuff Tendon Diseases Among Community-Dwelling Elders: A Cross-Sectional Quantitative Ultrasound Study. Front Med (Lausanne). 2021 May 5;8:630009. doi: 10.3389/fmed.2021.630009. eCollection 2021.
PubMed 34026779Kara M, Kara O, Durmus ME, Analay P, Sener FE, Citir BN, Korkmaz GO, Unlu Z, Tiftik T, Gurcay E, Mulkoglu C, Yalcinkaya B, Bagcier F, Aksakal MF, Erdogan K, Sertcelik A, Cakir B, Kaymak B, Ozcakar L. The Relationship Among Probable SARCopenia, Osteoporosis and SuprasPinatus Tendon Tears in Postmenopausal Women: The SARCOSP Study. Calcif Tissue Int. 2024 Apr;114(4):340-347. doi: 10.1007/s00223-024-01183-7. Epub 2024 Feb 12.
PubMed 38342790Kim JH, Jang I, Jeong S, Shin J, Yoon S, Lee H, Lee S. Examining the Relationship Between Sarcopenia and Rotator Cuff Tears: A Retrospective Comparative Study. J Clin Med. 2025 Jan 2;14(1):220. doi: 10.3390/jcm14010220.
PubMed 39797302
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sarcopenia Influence Rotator Cuff Tear Patterns? Radiological Insights From Patients With Rotator Cuff Syndrome
- ClinicalTrials.gov ID
- NCT07183774
- Acronym / sponsor ID
- HNEAH-BAEK 2024/123
- Conditions
- Rotator Cuff Tears, Sarcopenia, Shoulder Pain, Rotator Cuff Syndrome
- Keywords
- Rotator cuff syndrome, Rotator cuff tear, Sarcopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (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.
Sarcopenia is the loss of muscle mass due to aging, which consequently leads to a decline in muscle function. It is considered an independent risk factor for falls and fractures, disability, postoperative complications, and mortality. Rotator cuff tears are known to be influenced by systemic diseases such as diabetes, hypercholesterolemia, thyroid disorders, and osteoporosis. The aim of our study is to investigate whether there is a relationship between sarcopenia and rotator cuff tears, and if so, to determine the location and type of the tear.
Detailed description
Patients aged between 40 and 75 years who present to the Physical Medicine and Rehabilitation Department's Shoulder Outpatient Clinic with shoulder pain lasting for at least three months, have undergone shoulder MRI as part of their diagnostic work-up, and have been clinically diagnosed with rotator cuff syndrome based on physical examination, will be included in the study.
Demographic data of the patients will be recorded. A detailed history regarding shoulder pain will be obtained. Pain severity will be assessed using the Visual Analog Scale (VAS), and shoulder functional impairment will be evaluated using the Shoulder Disability Questionnaire.
Following the clinical assessment of shoulder pain, sarcopenia evaluation will be performed by a different physician who is blinded to the patients' imaging and clinical findings. Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.
In this method, gait speed, handgrip strength (measured with a dynamometer), and the chair stand test will first be conducted. For gait speed, a 6-meter walking track will be used, and patients will be instructed to walk at their normal pace. The time will be recorded with a stopwatch, and each patient will perform the test three times, with the average recorded in meters per second (m/s).
In the chair stand test, the patient will be asked to rise from a chair five times as quickly as possible without using their arms, keeping both hands crossed over the chest (opposite shoulders). The time taken will be recorded with a stopwatch.
Handgrip strength will be measured using a Jamar dynamometer, with the shoulder in adduction, elbow at 90° flexion, and the wrist and hand in a neutral position. The patient will repeat the test three times, and the highest value will be recorded.
Patients will then be evaluated based on whether their gait speed is below 1.0 m/s, grip strength is 2 standard deviations below the norm, or chair stand time is ≥12 seconds.
Subsequently, anterior thigh muscle thickness will be measured using ultrasonography. Based on this comprehensive evaluation, patients will be categorized as non-sarcopenic, pre-sarcopenic, or sarcopenic.
At the end of the study, the shoulder MRIs of patients in each of these three categories will be analyzed to assess the presence, type, and severity of rotator cuff tears. This study aims to determine whether sarcopenia predisposes individuals to rotator cuff tears and, if so, what type of tear is more likely to occur in sarcopenic patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with rotator cuff tear | – | Diagnostic Test: Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.Patients with parsiyel or full thickness rotator cuff tear in supraspinatus tendon |
| Patients without rotator cuff tear | – | Diagnostic Test: Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.Patients without tear in supraspnatus tendon |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study's target population will be patients aged 40 to 75 who have experienced shoulder pain for longer than three months and who have been physically evaluated and found to have rotator cuff syndrome.
Key inclusion criteria (2 listed)
- Patients with rotator cuff syndrome
- Aged between 40 and 75 years
Key exclusion criteria (7 listed)
- History of previous shoulder surgery
- Presence of shoulder pathology other than rotator cuff syndrome
- History of surgical intervention involving the hip or thigh region
- Being wheelchair-bound or bedridden
- Presence of an oncologic 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 |
|---|---|---|
| Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.Also: Shoulder MRIs of patients in each of these three categories will be analyzed to assess the presence, type, and severity of rotator cuff tears.A detailed evaluation of shoulder MRI scans will be conducted. The presence and severity of supraspinatus tendon tears, as well as the presence of muscle atrophy (assessed using the tangent sign), will be recorded. In addition, tears in other rotator cuff tendons, signs of tendinitis, and any other pathological findings will also be documented. | Diagnostic test | Patients with rotator cuff tear, Patients without rotator cuff tear |
Primary outcome
STAR value
Time frame: Baseline
Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method. In this method, gait speed, handgrip strength (measured with a dynamometer), and the chair stand test will first be conducted. For gait speed, a 6-meter walking track will be used, and patients will be instructed to walk at their normal pace. The time will be recorded with a stopwatch, and each patient will perform the test three times, with the average recorded in meters per second (m/s). Subsequently, anterior thigh muscle thickness will be measured using ultrasonography. Based on this comprehensive evaluation, patients will be categorized as non-sarcopenic, pre-sarcopenic, or sarcopenic.
1 secondary outcome
Radiologic evaluation of shoulder MRI
Time frame: Baseline
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 26 Nov 2025.
- Results publication: PubMed 33157241Atala NA, Bongiovanni SL, Galich AM, Bruchmann MG, Rossi LA, Tanoira I, Ranalletta M. Is sarcopenia a risk factor for rotator cuff tears? J Shoulder Elbow Surg. 2021 Aug;30(8):1851-1855. doi: 10.1016/j.jse.2020.10.001. Epub 2020 Nov 4.
- Results publication: PubMed 27083579Chung SW, Yoon JP, Oh KS, Kim HS, Kim YG, Lee HJ, Jeong WJ, Kim DH, Lee JS, Yoon JW. Rotator cuff tear and sarcopenia: are these related? J Shoulder Elbow Surg. 2016 Sep;25(9):e249-55. doi: 10.1016/j.jse.2016.02.008. Epub 2016 Apr 12.
- Results publication: PubMed 34026779Han DS, Wu WT, Hsu PC, Chang HC, Huang KC, Chang KV. Sarcopenia Is Associated With Increased Risks of Rotator Cuff Tendon Diseases Among Community-Dwelling Elders: A Cross-Sectional Quantitative Ultrasound Study. Front Med (Lausanne). 2021 May 5;8:630009. doi: 10.3389/fmed.2021.630009. eCollection 2021.
- Results publication: PubMed 38342790Kara M, Kara O, Durmus ME, Analay P, Sener FE, Citir BN, Korkmaz GO, Unlu Z, Tiftik T, Gurcay E, Mulkoglu C, Yalcinkaya B, Bagcier F, Aksakal MF, Erdogan K, Sertcelik A, Cakir B, Kaymak B, Ozcakar L. The Relationship Among Probable SARCopenia, Osteoporosis and SuprasPinatus Tendon Tears in Postmenopausal Women: The SARCOSP Study. Calcif Tissue Int. 2024 Apr;114(4):340-347. doi: 10.1007/s00223-024-01183-7. Epub 2024 Feb 12.
- Results publication: PubMed 39797302Kim JH, Jang I, Jeong S, Shin J, Yoon S, Lee H, Lee S. Examining the Relationship Between Sarcopenia and Rotator Cuff Tears: A Retrospective Comparative Study. J Clin Med. 2025 Jan 2;14(1):220. doi: 10.3390/jcm14010220.
- Individual participant dataSharing planned: Undecided
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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.
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 Tears and Sarcopenia, run by Haydarpasa Numune Training and Research Hospital 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 7 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 26 Nov 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?
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 sibel Suzen Ozbayrak, M.D. (+90 506 343 81 87, sibels62@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAR value (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183774, which also lists 5 linked publications.
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 26 Nov 2025.