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.
Visão geral do estudo
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Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Erdal Güngör, M.D
- Número de telefone: +905438790630
- E-mail: egungor_49@hotmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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.
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Patients Without 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Primary Outcome: Change in SPADI Total Score
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Visual Analog Scale (VAS) Pain Score
Prazo: Baseline (preoperative) and postoperative 3 months
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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.
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Baseline (preoperative) and postoperative 3 months
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Change in Central Sensitization Inventory (CSI) Score
Prazo: Baseline (preoperative) and postoperative 3 months
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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.
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Baseline (preoperative) and postoperative 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Erdal Güngör, M.D, Istanbul Medipol University, Department of Orthopedics and Traumatology
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EG-RCR-CS-2026-01
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