Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury

NCT06946472 | Not Yet Recruiting

• 1 other identifier: MetS-2025-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injury (RCI); Metabolic Syndrome (MetS)

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  Baseline and post-treatment (approximately 4 weeks)

Secondary Outcomes (3)

• Change in Muscle Strength (Digital Hand Dynamometer)

  Baseline and post-treatment (approximately 4 weeks)

• Change in Kinesthetic Awareness (Joint Position Sense - JPS)

  Baseline and post-treatment (approximately 4 weeks)

• Change in Shoulder Function (Quick Disabilities of the Arm, Shoulder, and Hand - Quick DASH)

  Baseline and post-treatment (approximately 4 weeks)

Study Arms (2)

RCI with MetS

Participants with rotator cuff injury and diagnosed metabolic syndrome.

RCI without MetS

Participants with rotator cuff injury but without metabolic syndrome.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Elif Dilara Durmaz: lead

Study Sites (1)

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, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Elif Dilara DURMAZ, MSc, Spec

CONTACT

+905072367034; elifdilaradurmaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 27, 2025
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

TU (1)