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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Erdal Güngör, M.D
- 電話番号：+905438790630
- メール：egungor_49@hotmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Outcome: Change in SPADI Total Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Erdal Güngör, M.D、Istanbul Medipol University, Department of Orthopedics and Traumatology
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EG-RCR-CS-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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