Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorElif Dilara Durmaz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18-65 years

Willing to participate in the study

Unilateral Rotator Cuff Tear (RMY)

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: RCI with MetS
Group B: RCI without MetS

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and post-treatment (approximately 4 weeks)
2

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)

Time frame
Baseline and post-treatment (approximately 4 weeks)

Secondary outcomes

1

Change in Muscle Strength (Digital Hand Dynamometer)

Muscle strength will be measured using a digital hand dynamometer to assess the strength of the shoulder's flexors, abductors, and internal/external rotators. Measurements will be performed bilaterally for comparison. The strength will be measured according to standard protocols, with patients performing the maximal force exertion during the testing. Each muscle group will be tested three times for accuracy, and the average of the three measurements will be used for analysis. The dynamometer will measure the maximum force exerted by the patient, and if the patient is unable to tolerate pain during the measurement, the assessment will be terminated. This will be measured before and after the treatment to evaluate changes in muscle strength. Measure Type: Muscle Strength (Maximum Force) Unit of Measure: Kilograms (kg) or Newtons (N)

Time frame
Baseline and post-treatment (approximately 4 weeks)
2

Change in Kinesthetic Awareness (Joint Position Sense - JPS)

Kinesthetic awareness (joint position sense) will be measured for the shoulder in terms of flexion and abduction. Using a digital inclinometer, the participant's ability to accurately replicate joint positions (90° flexion and 90° abduction) will be tested. The participant will close their eyes and be asked to reproduce the position of the shoulder three times for each movement. The difference between the target and the achieved angle will be recorded. The average deviation from the target angle will be used for analysis. This will be measured before and after the treatment to assess improvements in proprioceptive abilities. Measure Type: Joint Position Sense (JPS) Unit of Measure: Degrees (°)

Time frame
Baseline and post-treatment (approximately 4 weeks)
3

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

Shoulder function will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. This version of the DASH scale consists of 11 questions about the patient's ability to perform activities of daily living, specifically related to the arm and shoulder. The answers are rated from 1 (no difficulty) to 5 (unable to do). The total score is calculated by averaging the responses, subtracting 1, and multiplying by 25. A higher score indicates greater disability. This will be measured before and after the treatment to assess improvements in functional ability. Measure Type: Shoulder Function Unit of Measure: Score (0 to 100 scale)

Time frame
Baseline and post-treatment (approximately 4 weeks)

Other outcomes

Sponsors and contacts

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Elif Dilara Durmaz

Lead sponsor

Istinye University

Sponsor institution

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