Clinical trial NCT06946472: Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury
Official title: Investigating the Impact of Metabolic Syndrome on Pain, Muscle Strength, Kinesthesia, and Functionality in Rotator Cuff Injury Rehabilitation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rotator Cuff Injury (RCI)
Metabolic Syndrome (MetS)
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Shoulder Pain Severity (Visual Analog Scale - VAS)
timeFrame: Baseline and post-treatment (approximately 4 weeks)
measure: Change in Pain Threshold (Algometer)
timeFrame: Baseline and post-treatment (approximately 4 weeks)
Secondary outcomes:
measure: Change in Muscle Strength (Digital Hand Dynamometer)
timeFrame: Baseline and post-treatment (approximately 4 weeks)
measure: Change in Kinesthetic Awareness (Joint Position Sense - JPS)
timeFrame: Baseline and post-treatment (approximately 4 weeks)
measure: Change in Shoulder Function (Quick Disabilities of the Arm, Shoulder, and Hand - Quick DASH)
timeFrame: Baseline and post-treatment (approximately 4 weeks)
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Name: Karamanoğlu Mehmetbey University Faculty of Medicine, Yunus Emre Mah. Dr. Aziz Tarhan Cad. No:21 City: Karaman Postal Code: 70200 Country: Turkey
Study officials:
References: