Comparison of Subjective Outcomes and Changes of Ultrasonographic Morphology of Median Nerves of Mini-open and Endoscopic Carpal Tunnel Release in Patients With Idiopathic Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
研究概览
简要总结
A few studies have shown that the mini-incision release technique decreases the pathologic swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic release technique similarly reverses these pathological changes in the median nerve along the carpal tunnel in patients with CTS compared with the mini-incision release.
Investigators therefore conducted the current study to compare the subjective outcomes and US-measured morphological changes in the median nerve in patients with CTS who received either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function scores and the DASH scores, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or endoscopic carpal tunnel release.
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
- None
入排标准
- 年龄范围
- 27 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 20 years or older.
- •Patients with idiopathic CTS that was confirmed by electrodiagnostic tests
- •Patients with idiopathic CTS who were scheduled for carpal tunnel release
排除标准
- •Patients with a history of wrist-area fracture or dislocation
- •Patients with previous carpal tunnel release
- •Patients with associated cervical radiculopathy, cubital tunnel syndrome, thoracic outlet syndrome, diabetes mellitus, hypothyroidism, arthritis, or Burger's disease
- •Patients with cognitive impairment that affected the patient's ability to complete the questionnaires
- •Patients with worker's compensation issues
- •Patients with inadequate follow-up (i.e., less than 24 weeks post-operation)
结局指标
主要结局
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: preoperatively and 24 weeks post-operation
The BCTQ is a disease-specific status scale that incorporates both a symptom severity scale and a functional scale. The symptom severity scale (BCTQ-S) is comprised of eleven items that address the severity, frequency, and duration of symptoms, whereas the functional status scale (BCTQ-F) is comprised of eight questions that assess the difficulty of performing eight daily tasks. Each question offers five possible responses of increasing severity, which are scored from 1 (none) to 5 (most severe); the mean values of all the items in the BCTQ were calculated.
次要结局
- Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire(preoperatively and 24 weeks post-operation)