Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair (NCT07667257) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair
50 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome: Change in SPADI Total Score
Timeframe: Baseline (preoperative) and postoperative 3 months