Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome ：A Randomized Double-blind Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- sensation
研究概览
简要总结
The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.
详细描述
The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with confirmed cubital tunnel syndrome
- •moderate and severe cubital tunnel syndrome.
排除标准
- •Significant cervical spine and shoulder disease
- •deformity or distortion of the cubital tunnel due to previous trauma to elbow
- •recurrent cubital tunnel syndrome after previous surgery
- •mild cubital tunnel syndrome.
结局指标
主要结局
sensation
时间窗: at 6 months post-operatively
Sensory disturbance were tested with Semmes-Weinstein filaments and sensory deficits were categorized according to the Yale sensory scale. According to standard scoring system that designed, the severity of sensation and function of the ulnar nerve was scored as follows: ---- 0, Abscent sensation; 1, Decrease or abnormal sensation; 2, Intact sensation.
次要结局
- Muscle strength(at 6 months post-operatively)
- pain(at 6 months post-operatively)
- electromyography(at 6 months post-operatively)
研究者
Rui Li
chief doctor and PhD supervisor
Jilin University