Rotator Cuff Injury (RCI)RMY-METSNCT06946472
Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury
An observational study of Rotator Cuff Injury (RCI) and Metabolic Syndrome (MetS), run by Elif Dilara Durmaz at 1 site in Turkey (Türkiye).
Trial summary
This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injury (RCI), Metabolic Syndrome (MetS)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 5 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include individuals aged 18-65, divided into two groups: Non-MetS Group: Individuals with unilateral rotator cuff tear (RMY) and no Metabolic Syndrome (MetS). MetS Group: Individuals with unilateral RMY and MetS, defined by meeting at least three of the NCEP-ATP III criteria, with stable metabolic syndrome (no major medical changes in the last 3 months). Exclusion Criteria: Participants will be excluded if they have: Inability to cooperate or mental health issues. Cervical radiculopathy or other shoulder pathologies (e.g., fractures, arthritis). Recent steroid injections, physiotherapy, or surgery (within 3 months). Neurological, vascular, or cardiac disorders. Systemic inflammatory diseases or significant postural issues.
Who may be able to join
- Aged between 18-65 years
- Willing to participate in the study
- Unilateral Rotator Cuff Tear (RMY)
- In addition to the above criteria, meeting at least three of the NCEP-ATP III consensus criteria for Metabolic Syndrome Stable metabolic syndrome (e.g., no significant medical changes in the last 3 months)
- Exclusion Criteria for All Participants:
- Inability to cooperate with the tests or presence of mental health issues
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- Presence of cervical radiculopathy symptoms
- Presence of other orthopedic pathologies in the same shoulder (e.g., fracture, prosthesis, avascular necrosis, advanced shoulder osteoarthritis, frozen shoulder, severe scapular dyskinesia, neurological diseases, etc.)
- Presence of function-limiting neurological, vascular, or cardiac issues
- Local steroid injection to the shoulder within the last 3 months
- Receipt of physiotherapy or rehabilitation within the last 3 months
- Systemic rheumatic or inflammatory diseases
- Surgical history due to chronic rotator cuff tear
- Diagnosis of glenohumeral joint or acromioclavicular joint arthritis
- Severe scapular dysfunction or significant postural abnormalities
Who cannot join
None listed.
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
Name: Karamanoğlu Mehmetbey University Faculty of Medicine, Yunus Emre Mah. Dr. Aziz Tarhan Cad. No:21 City: Karaman Postal Code: 70200 Country: Turkey
Karaman, 70200
About this study
Official title: Investigating the Impact of Metabolic Syndrome on Pain, Muscle Strength, Kinesthesia, and Functionality in Rotator Cuff Injury Rehabilitation
This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Patients diagnosed with RCI will be divided into two groups based on the presence or absence of MetS, determined by NCEP-ATP III criteria. Both groups will receive the same 4-week physiotherapy protocol including hot pack, TENS, ultrasound, and therapeutic exercises. Pain intensity, pain threshold, muscle strength, kinesthesia, and shoulder functionality will be evaluated before and after treatment. The study hypothesizes that the presence of MetS negatively affects rehabilitation outcomes in patients with RCI by altering inflammation and tissue healing processes.
Read the detailed description
This study aims to investigate the differences in shoulder function and rotator cuff tear outcomes between individuals with and without Metabolic Syndrome (MetS). Participants will be divided into two groups: the MetS group, which meets at least three of the NCEP-ATP III criteria for Metabolic Syndrome, and the non-MetS group, which does not have MetS.
Both groups will undergo an initial assessment, focusing on shoulder function, rotator cuff tear status, and associated factors such as age, gender, and general health conditions. The study will explore how MetS may impact the recovery and function of the shoulder in individuals with rotator cuff tears, aiming to provide insights into potential treatment and rehabilitation strategies for this population.
Data will be collected at a single time point (cross-sectional study) to evaluate baseline conditions and differences between the two groups. Statistical analyses will be performed to compare outcomes and explore potential correlations with MetS criteria.
- Medical subject headings
- Rotator Cuff Injuries, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RCI with MetS | Participants with rotator cuff injury and diagnosed metabolic syndrome. | |
| RCI without MetS | Participants with rotator cuff injury but without metabolic syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain Severity (Visual Analog Scale - VAS)
Pain severity will be assessed in individuals with Myofascial Pain Syndrome (MPS) affecting the shoulder using the Visual Analog Scale (VAS). The VAS is a 10 cm horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate their pain both at rest and during common daily activities (e.g., lifting the arm, brushing hair, dressing, reaching).
Measurements will be conducted twice: once before the treatment (baseline) and once after the intervention period to evaluate changes in pain intensity.
Measured: Baseline and post-treatment (approximately 4 weeks)
Change in Pain Threshold (Algometer)
Pain threshold will be assessed using an algometer. The device measures the point at which pressure induces discomfort or pain. The algometer will be applied to the deltoid muscle of the affected shoulder. Participants will be asked to report when they first feel discomfort or pain, and this point will be recorded as their pain threshold. The measurement will be repeated three times for each participant, with a 30-second rest period between measurements. The average of the three measurements will be used for analysis.
This will be measured before and after the treatment to observe any changes in pain threshold.
Measure Type:
Pain Threshold
Unit of Measure:
Pressure (in kilopascals, kPa)
Measured: Baseline and post-treatment (approximately 4 weeks)
Secondary outcomes (3)
Change in Muscle Strength (Digital Hand Dynamometer)
Muscle strength will be measured using a digital hand dynamometer to assess the strength of the shoulder's flexors, abductors, and internal/external rotators. Measurements will be performed bilaterally for comparison. The strength will be measured according to standard protocols, with patients performing the maximal force exertion during the testing.
Each muscle group will be tested three times for accuracy, and the average of the three measurements will be used for analysis. The dynamometer will measure the maximum force exerted by the patient, and if the patient is unable to tolerate pain during the measurement, the assessment will be terminated.
This will be measured before and after the treatment to evaluate changes in muscle strength.
Measure Type:
Muscle Strength (Maximum Force)
Unit of Measure:
Kilograms (kg) or Newtons (N)
Measured: Baseline and post-treatment (approximately 4 weeks)
Change in Kinesthetic Awareness (Joint Position Sense - JPS)
Kinesthetic awareness (joint position sense) will be measured for the shoulder in terms of flexion and abduction. Using a digital inclinometer, the participant's ability to accurately replicate joint positions (90° flexion and 90° abduction) will be tested. The participant will close their eyes and be asked to reproduce the position of the shoulder three times for each movement. The difference between the target and the achieved angle will be recorded. The average deviation from the target angle will be used for analysis.
This will be measured before and after the treatment to assess improvements in proprioceptive abilities.
Measure Type:
Joint Position Sense (JPS)
Unit of Measure:
Degrees (°)
Measured: Baseline and post-treatment (approximately 4 weeks)
Change in Shoulder Function (Quick Disabilities of the Arm, Shoulder, and Hand - Quick DASH)
Shoulder function will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. This version of the DASH scale consists of 11 questions about the patient's ability to perform activities of daily living, specifically related to the arm and shoulder. The answers are rated from 1 (no difficulty) to 5 (unable to do). The total score is calculated by averaging the responses, subtracting 1, and multiplying by 25. A higher score indicates greater disability.
This will be measured before and after the treatment to assess improvements in functional ability.
Measure Type:
Shoulder Function
Unit of Measure:
Score (0 to 100 scale)
Measured: Baseline and post-treatment (approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start15 Jul 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion5 Dec 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 Injury (RCI)Studies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Elif Dilara Durmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Dilara Durmaz, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946472
- Sponsor's protocol ID
- MetS-2025-001
- Acronym
- RMY-METS
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Metabolic Syndrome on Pain, Muscle Strength, Kinesthesia, and Functionality in Rotator Cuff Injury Rehabilitation
- ClinicalTrials.gov ID
- NCT06946472
- Acronym / sponsor ID
- RMY-METS / MetS-2025-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Elif Dilara DurmazUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 27 Apr 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.
This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Patients diagnosed with RCI will be divided into two groups based on the presence or absence of MetS, determined by NCEP-ATP III criteria. Both groups will receive the same 4-week physiotherapy protocol including hot pack, TENS, ultrasound, and therapeutic exercises. Pain intensity, pain threshold, muscle strength, kinesthesia, and shoulder functionality will be evaluated before and after treatment. The study hypothesizes that the presence of MetS negatively affects rehabilitation outcomes in patients with RCI by altering inflammation and tissue healing processes.
Detailed description
This study aims to investigate the differences in shoulder function and rotator cuff tear outcomes between individuals with and without Metabolic Syndrome (MetS). Participants will be divided into two groups: the MetS group, which meets at least three of the NCEP-ATP III criteria for Metabolic Syndrome, and the non-MetS group, which does not have MetS.
Both groups will undergo an initial assessment, focusing on shoulder function, rotator cuff tear status, and associated factors such as age, gender, and general health conditions. The study will explore how MetS may impact the recovery and function of the shoulder in individuals with rotator cuff tears, aiming to provide insights into potential treatment and rehabilitation strategies for this population.
Data will be collected at a single time point (cross-sectional study) to evaluate baseline conditions and differences between the two groups. Statistical analyses will be performed to compare outcomes and explore potential correlations with MetS criteria.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCI with MetS | – | –Participants with rotator cuff injury and diagnosed metabolic syndrome. |
| RCI without MetS | – | –Participants with rotator cuff injury but without metabolic syndrome. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include individuals aged 18-65, divided into two groups: Non-MetS Group: Individuals with unilateral rotator cuff tear (RMY) and no Metabolic Syndrome (MetS). MetS Group: Individuals with unilateral RMY and MetS, defined by meeting at least three of the NCEP-ATP III criteria, with stable metabolic syndrome (no major medical changes in the last 3 months). Exclusion Criteria: Participants will be excluded if they have: Inability to cooperate or mental health issues. Cervical radiculopathy or other shoulder pathologies (e.g., fractures, arthritis). Recent steroid injections, physiotherapy, or surgery (within 3 months). Neurological, vascular, or cardiac disorders. Systemic inflammatory diseases or significant postural issues.
Key inclusion criteria (15 listed)
- In addition to the above criteria, meeting at least three of the NCEP-ATP III consensus criteria for Metabolic Syndrome Stable metabolic syndrome (e.g., no significant medical changes in the last 3 months)
- Exclusion Criteria for All Participants:
- Inability to cooperate with the tests or presence of mental health issues
- Presence of cervical radiculopathy symptoms
- Presence of other orthopedic pathologies in the same shoulder (e.g., fracture, prosthesis, avascular necrosis, advanced shoulder osteoarthritis, frozen shoulder, severe scapular dyskinesia, neurological diseases, etc.)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Shoulder Pain Severity (Visual Analog Scale - VAS)
Time frame: Baseline and post-treatment (approximately 4 weeks)
Pain severity will be assessed in individuals with Myofascial Pain Syndrome (MPS) affecting the shoulder using the Visual Analog Scale (VAS). The VAS is a 10 cm horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate their pain both at rest and during common daily activities (e.g., lifting the arm, brushing hair, dressing, reaching). Measurements will be conducted twice: once before the treatment (baseline) and once after the intervention period to evaluate changes in pain intensity.
Change in Pain Threshold (Algometer)
Time frame: Baseline and post-treatment (approximately 4 weeks)
Pain threshold will be assessed using an algometer. The device measures the point at which pressure induces discomfort or pain. The algometer will be applied to the deltoid muscle of the affected shoulder. Participants will be asked to report when they first feel discomfort or pain, and this point will be recorded as their pain threshold. The measurement will be repeated three times for each participant, with a 30-second rest period between measurements. The average of the three measurements will be used for analysis. This will be measured before and after the treatment to observe any changes in pain threshold. Measure Type: Pain Threshold Unit of Measure: Pressure (in kilopascals, kPa)
3 secondary outcomes
Change in Muscle Strength (Digital Hand Dynamometer)
Time frame: Baseline and post-treatment (approximately 4 weeks)
Change in Kinesthetic Awareness (Joint Position Sense - JPS)
Time frame: Baseline and post-treatment (approximately 4 weeks)
Change in Shoulder Function (Quick Disabilities of the Arm, Shoulder, and Hand - Quick DASH)
Time frame: Baseline and post-treatment (approximately 4 weeks)
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 21 Apr 2026.
Related trials for Rotator Cuff Injury (RCI)
Recruiting
Effectiveness of Core Stabilization Exercises in Rotator Cuff Injuries
Rotator Cuff Injury (RCI), Core Exercises Training
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 Injury (RCI) and Metabolic Syndrome (MetS), run by Elif Dilara Durmaz 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 15 inclusion and 0 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: opening soon, as of the sponsor's last update on 21 Apr 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 Elif Dilara DURMAZ, MSc, Spec (+905072367034, elifdilaradurmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain Severity (Visual Analog Scale - VAS) (time frame: Baseline and post-treatment (approximately 4 weeks)). The study lists 2 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 21 Apr 2026.