Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMedipol University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Arthroscopic Rotator Cuff Repair

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Patients With Central Sensitization1 intervention
Group B: Patients Without Central Sensitization1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (preoperative) and postoperative 3 months

Secondary outcomes

1

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.

Time frame
Baseline (preoperative) and postoperative 3 months
2

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.

Time frame
Baseline (preoperative) and postoperative 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: