The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- The Visual Analogue Scale (VAS) pain score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
- •Uncontrolled hypertension (evidenced by a resting blood pressure of more than 100 mmHg)
- •Liver function abnormalities (aspartate aminotransferase or alanine aminotransferase >60 IU/litre).
- •major cardiovascular diseases or renal impairments
研究组 & 干预措施
Pregabalin group
干预措施: Pregabalin (Drug)
结局指标
主要结局
The Visual Analogue Scale (VAS) pain score
时间窗: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months
Pain score evaluation from 0 to 10, 10 meaning the maximum pain
次要结局
- Constant shoulder score(Preoperative, postoperative 6 months and 12 months)
- American shouler and elbow surgeons (ASES) score(Preoperative, postoperative 6 months and 12 months)
研究者
Hyungsuk Kim
Assistant professor
The Catholic University of Korea