Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair (ARCS)
Effect of Central Sensitization on Postoperative Clinical Outcomes in Patients Undergoing Arthroscopic Rotator Cuff Repair
This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated.
Adult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This prospective, single-center, observational study is designed to evaluate the impact of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Rotator cuff tears are among the most common causes of shoulder pain and functional disability, and although arthroscopic repair generally provides satisfactory outcomes, a considerable proportion of patients continue to experience persistent pain and functional limitations after surgery.
Recent evidence suggests that pain perception is influenced not only by structural pathology but also by alterations in central pain processing mechanisms. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and has been associated with greater pain severity, impaired physical function, and poorer quality of life in patients with musculoskeletal disorders. However, the influence of preoperative central sensitization on postoperative recovery following arthroscopic rotator cuff repair remains insufficiently investigated.
Adult patients aged 18-65 years with a rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be consecutively enrolled. Demographic and clinical characteristics, including age, sex, body mass index, symptom duration, dominant side, and affected shoulder, will be recorded. Preoperative central sensitization will be evaluated using the Central Sensitization Inventory (CSI). Pain intensity will be assessed using the Visual Analog Scale (VAS), and shoulder function will be evaluated using the Shoulder Pain and Disability Index (SPADI).
Clinical assessments will be performed at baseline (preoperatively) and at postoperative 3 months. Participants will be classified according to their preoperative CSI scores, with a CSI score of ≥40 considered indicative of central sensitization. Postoperative clinical outcomes will be compared between patients with and without central sensitization. The primary objective is to determine whether preoperative central sensitization is associated with postoperative shoulder function, while secondary objectives include evaluating its relationship with postoperative pain and overall clinical recovery.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Erdal Güngör, M.D
- Номер телефона: +905438790630
- Электронная почта: egungor_49@hotmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Inclusion Criteria:
- Age between 18 and 65 years
- Diagnosis of rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI)
- Scheduled to undergo arthroscopic rotator cuff repair
- Ability to understand and complete study questionnaires
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Previous surgery on the affected shoulder.
- Concomitant shoulder disorders requiring additional surgical procedures (e.g., fracture, instability, advanced glenohumeral osteoarthritis).
- History of inflammatory rheumatic disease, active infection, or malignancy affecting the shoulder.
- Neurological disorders that may influence pain perception or upper extremity function.
- Severe psychiatric illness or cognitive impairment preventing completion of the questionnaires.
- Pregnancy.
- Inability or unwillingness to provide written informed consent.
- Inability to attend the postoperative 3-month follow-up evaluation.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Patients With Central Sensitization
Patients with a preoperative Central Sensitization Inventory score of ≥40.
|
All enrolled patients will undergo standard arthroscopic rotator cuff repair according to institutional clinical practice.
The study is observational, and no additional intervention will be administered as part of the research protocol.
|
|
Patients Without Central Sensitization
Patients with a preoperative Central Sensitization Inventory score of <40.
|
All enrolled patients will undergo standard arthroscopic rotator cuff repair according to institutional clinical practice.
The study is observational, and no additional intervention will be administered as part of the research protocol.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Primary Outcome: Change in SPADI Total Score
Временное ограничение: Baseline (preoperative) and postoperative 3 months
|
The primary outcome is the change in the total Shoulder Pain and Disability Index (SPADI) score from baseline to postoperative 3 months.
The SPADI assesses shoulder pain and disability and consists of pain and disability subscales.
The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability.
Lower scores indicate better shoulder function and less pain.
The change will be compared according to preoperative central sensitization status.
|
Baseline (preoperative) and postoperative 3 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
Временное ограничение: Baseline (preoperative) and postoperative 3 months
|
The change in pain intensity assessed using the Visual Analog Scale (VAS).
The VAS is scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate less pain.
The change from baseline (preoperative assessment) to postoperative 3 months will be evaluated.
|
Baseline (preoperative) and postoperative 3 months
|
|
Change in Central Sensitization Inventory (CSI) Score
Временное ограничение: Baseline (preoperative) and postoperative 3 months
|
The change in Central Sensitization Inventory (CSI) score used to assess symptoms related to central sensitization.
The CSI score ranges from 0 to 100, with higher scores indicating greater symptoms of central sensitization.
The change from baseline (preoperative assessment) to postoperative 3 months will be evaluated.
|
Baseline (preoperative) and postoperative 3 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Erdal Güngör, M.D, Istanbul Medipol University, Department of Orthopedics and Traumatology
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- EG-RCR-CS-2026-01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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