Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury (NCT06946472) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury
Turkey (Türkiye)40 participantsStarted 2026-07-15
Plain-language 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). 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria for the Non-MetS Group:
* Aged between 18-65 years
* Willing to participate in the study
* Unilateral Rotator Cuff Tear (RMY)
* Inclusion Criteria for the MetS Group:
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.)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Shoulder Pain Severity (Visual Analog Scale - VAS)
Timeframe: Baseline and post-treatment (approximately 4 weeks)
2
Change in Pain Threshold (Algometer)
Timeframe: Baseline and post-treatment (approximately 4 weeks)