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Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair (ARCS)

20 giugno 2026 aggiornato da: Erdal Güngör, Medipol University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population will consist of adult patients aged 18-65 years with a rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI) who are scheduled to undergo arthroscopic rotator cuff repair at the Department of Orthopedics and Traumatology of a single tertiary care center. Eligible patients who meet the inclusion criteria and provide written informed consent will be consecutively enrolled. Preoperative and postoperative clinical evaluations, including assessment of central sensitization, pain, and shoulder function, will be performed according to the study protocol.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Patients With Central Sensitization
Patients with a preoperative Central Sensitization Inventory score of ≥40.
Procedura: Arthroscopic Rotator Cuff Repair
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.
Procedura: Arthroscopic Rotator Cuff Repair
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Primary Outcome: Change in SPADI Total Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Visual Analog Scale (VAS) Pain Score
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medipol University

Investigatori

  • Investigatore principale: Erdal Güngör, M.D, Istanbul Medipol University, Department of Orthopedics and Traumatology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

15 dicembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

12 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EG-RCR-CS-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be made publicly available.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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