Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury (RMY-METS)

Elif Dilara Durmaz

Status

Active, not recruiting

Conditions

Rotator Cuff Injury (RCI)

Metabolic Syndrome (MetS)

Study type

Observational

Funder types

Other

Identifiers

NCT06946472

MetS-2025-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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