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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Erdal Güngör, M.D
- Numer telefonu: +905438790630
- E-mail: egungor_49@hotmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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Patients With Central Sensitization
Patients with a preoperative Central Sensitization Inventory score of ≥40.
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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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Primary Outcome: Change in SPADI Total Score
Ramy czasowe: Baseline (preoperative) and postoperative 3 months
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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.
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Baseline (preoperative) and postoperative 3 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
Ramy czasowe: 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
|
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Change in Central Sensitization Inventory (CSI) Score
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Erdal Güngör, M.D, Istanbul Medipol University, Department of Orthopedics and Traumatology
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EG-RCR-CS-2026-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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