A Phase 4 interventional study of Pregabalin in Rotator Cuff Tears, Central Sensitisation and Neuropathic Pain, sponsored by The Catholic University of Korea. Status unknown. Open to participants aged 20 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by The Catholic University of Korea · Phase 4, Interventional, and Supportive care
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.
745 studies on the registry are indexed under Rotator Cuff Injuries; 163 are open to participants now.
This study's planned enrollment of 76 is above the median of 60 across 547 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →The Catholic University of Korea is the lead sponsor of 155 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Drug: Pregabalin
Pregabalin oral intake from the day before surgery to six weeks postoperatively
Also known as: Lyrica
The Visual Analogue Scale (VAS) pain score
Pain score evaluation from 0 to 10, 10 meaning the maximum pain
Time frame: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months
Constant shoulder score
Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
Time frame: Preoperative, postoperative 6 months and 12 months
American shouler and elbow surgeons (ASES) score
Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
Time frame: Preoperative, postoperative 6 months and 12 months
No study locations are listed for this record.
Start is estimated for Sep 2024; primary completion for May 2025, 8 months later.
Of 21 phase 4 interventional studies under Rotator Cuff Injuries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pregabalin
The Catholic University of Korea →