About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Arthroscopic Rotator Cuff Repair
Procedure/SurgeryAll 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.
Treatment groups
Trial outcomes
Primary outcomes
Primary Outcome: Change in SPADI Total Score
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.
Secondary outcomes
Change in Visual Analog Scale (VAS) Pain Score
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.
Change in Central Sensitization Inventory (CSI) Score
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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Sponsors and contacts
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