Clinical Trial

Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair

Not Yet Recruiting Phase 4
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Record status
This record was last updated August 23, 2024 (before its estimated May 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair. The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-11; most recent amendment 2024-08-21.
Trial Details
NCT Number NCT06367998
Lead Sponsor The Catholic University of Korea
Collaborators: Viatris Korea
Conditions Rotator Cuff Tears, Central Sensitisation, Neuropathic Pain
Enrollment 76 participants
Start Date 2024-09-01
Primary Completion 2025-05-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-23