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Набор скоро начнётся NCT06946472

Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Injury (RCI), Metabolic Syndrome (MetS). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Change in Shoulder Pain Severity (Visual Analog Scale - VAS) [Срок оценки: Baseline and post-treatment (approximately 4 weeks)]
  • Change in Pain Threshold (Algometer) [Срок оценки: Baseline and post-treatment (approximately 4 weeks)]
Вторичные конечные точки (3)
  • Change in Muscle Strength (Digital Hand Dynamometer) [Срок оценки: Baseline and post-treatment (approximately 4 weeks)]
  • Change in Kinesthetic Awareness (Joint Position Sense - JPS) [Срок оценки: Baseline and post-treatment (approximately 4 weeks)]
  • Change in Shoulder Function (Quick Disabilities of the Arm, Shoulder, and Hand - Quick DASH) [Срок оценки: Baseline and post-treatment (approximately 4 weeks)]

Критерии участия

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

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

Идентификаторы

NCT: NCT06946472 · MetS-2025-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗