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Not yet recruiting NCT06946472

Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury

— Observational Rotator Cuff Injury (RCI) Metabolic Syndrome (MetS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Rotator Cuff Injury (RCI), Metabolic Syndrome (MetS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigating the Impact of Metabolic Syndrome on Pain, Muscle Strength, Kinesthesia, and Functionality in Rotator Cuff Injury Rehabilitation

Overview

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.

Primary outcome measures

  • Change in Shoulder Pain Severity (Visual Analog Scale - VAS) [Time frame: Baseline and post-treatment (approximately 4 weeks)]
  • Change in Pain Threshold (Algometer) [Time frame: Baseline and post-treatment (approximately 4 weeks)]
Secondary outcome measures (3)
  • 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Name: Karamanoğlu Mehmetbey University Faculty of Medicine, Yunus Emre Mah. Dr. Aziz Tarha — Karaman

Identifiers

NCT: NCT06946472 · MetS-2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗