A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- VAS pain score
研究概览
简要总结
The purpose of this study is to determine whether radio-frequency (RF)-based plasma micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40). Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and 1-year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 26 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a skeletally mature patient who agreed to participate in the study
- •shoulder impingement syndrome was diagnosed by one senior surgeon (CYJ) and without any sign of rotator cuff tear both on pre-operative MRI or intra-operative arthroscopic view
- •supraspinatous tendinosis was confirmed on preoperative MRI
- •the symptoms were not relieved by a standardized conservative treatment regime
- •patient underwent standard arthroscopic subacromial decompression surgery.
排除标准
- •any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding
- •concomitant biceps lesions or internal impingement
- •any history of surgical treatment on the same shoulder.
结局指标
主要结局
VAS pain score
时间窗: postoperative 3-week
次要结局
- Shoulder range of motion (ROM)(3-month, 6-month, 1-year)
- ASES score(3-month, 6-month, 1-year)
- UCLA score(UCLA score)
- Constant-Murley score(3-month, 6-month, 1-year)
- SST score(3-month, 6-month, 1-year)
研究者
Yi Lu
Deputy director of the physician
Beijing Hospital