Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair

NCT07667257 | Not Yet Recruiting

• 1 other identifier: EG-RCR-CS-2026-01
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rotator Cuff Tear

Outcome Measures

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.

  Baseline (preoperative) and postoperative 3 months

Secondary Outcomes (2)

• Change in Visual Analog Scale (VAS) Pain Score

  Baseline (preoperative) and postoperative 3 months

• Change in Central Sensitization Inventory (CSI) Score

  Baseline (preoperative) and postoperative 3 months

Study Arms (2)

Patients With Central Sensitization

Patients with a preoperative Central Sensitization Inventory score of ≥40.

Procedure: Arthroscopic Rotator Cuff Repair

Patients Without Central Sensitization

Patients with a preoperative Central Sensitization Inventory score of \<40.

Procedure: Arthroscopic Rotator Cuff Repair

Interventions

Arthroscopic Rotator Cuff Repair PROCEDURE

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 With Central Sensitization; Patients Without Central Sensitization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Erdal Güngör, M.D

  Istanbul Medipol University, Department of Orthopedics and Traumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdal Güngör, M.D

CONTACT

+905438790630; egungor_49@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Official Title:

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 25, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share