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| Name | Class |
|---|---|
| Viatris Korea | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin oral intake from the day before surgery to six weeks postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Visual Analogue Scale (VAS) pain score | Pain score evaluation from 0 to 10, 10 meaning the maximum pain | Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Constant shoulder score | Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function | Preoperative, postoperative 6 months and 12 months |
| American shouler and elbow surgeons (ASES) score |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
| Preoperative, postoperative 6 months and 12 months |
| D010523 |
| Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |