About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age over 19 to under 70
Underwent arthroscopic rotator cuff repair due to a tear of the rotator cuff.
Clinical diagnosis of myofascial pain syndrome
Central sensitization (Central Sensitization Inventory (CSI) score of 40 or above).
Disqualifiers
Previous history of Pregabalin prescription
Hypersensitivity reactions or severe complications after taking Pregabalin.
Diagnosed with and are being treated for psychiatric disorders
Localized infection, sepsis, or previous neurological abnormalities
Trial design
Parallel
Treatments tested in this trial
Pregabalin
DrugPregabalin oral intake from the day before surgery to six weeks postoperatively
Treatment groups
Trial outcomes
Primary outcomes
The Visual Analogue Scale (VAS) pain score
Pain score evaluation from 0 to 10, 10 meaning the maximum pain
Secondary outcomes
Constant shoulder score
Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
American shouler and elbow surgeons (ASES) score
Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
Locations
Sponsors and contacts
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The Catholic University of Korea
Lead sponsor
Viatris Korea
Collaborator
This trial is not recruiting at the moment. You can still explore other options: