Ultrasound Guided - Incisionless Thread Carpal Tunnel Release Versus Standard Mini-Open Carpal Tunnel Release for the Treatment of Carpal Tunnel Syndrome: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Visual analog pain scale
研究概览
简要总结
The overarching long-term goal is to develop a CTS Treatment Center within the Hand Clinic that offers a variety of established and emerging treatment options in a multidisciplinary program. The ultra-minimally invasive carpal tunnel release would be one component of the program. Furthering the knowledge with regard to ultra-minimally invasive carpal tunnel release outcomes would facilitate the Hand Clinics ability to offer this procedure as a component of individualized care in the CTS Treatment Center to facilitate delivery of the appropriate level of care to the right patient.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
- •Age 18-65 years old
- •Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
- •Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist
- •Ability to complete all follow up appointments
排除标准
- •Previous CTS surgical release on affected side
- •Diabetes mellitus
- •Hypothyroidism
- •Hand arthritis (rheumatologic or osteoarthritis)
- •Pregnancy
- •Electromyographic evidence of any condition other than CTS affecting the hand
- •Workman's compensation
- •Participants not willing to make follow-up visits
结局指标
主要结局
Visual analog pain scale
时间窗: Time Frame: Change from Baseline to 12 months
Pain that participant is currently experiencing the in the hand or risk(0-100)
Strength testing of grip
时间窗: Time Frame: Change from Baseline to 12 months
Use dynameters
Disability of the Arm Shoulder Hand DASH
时间窗: Time Frame: Change from Baseline to 12 months
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The main purpose of this study was to assess the longitudinal construct validity of the DASH among patients undergoing surgery. The second purpose was to quantify self-rated treatment effectiveness after surgery.
Strength testing of pinch
时间窗: Time Frame: Change from Baseline to 12 months
Use pinch meters
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score
时间窗: Time Frame: Change from Baseline to 12 months
Measured on a symptom severity scale from 1 to 5, where 1 is normal and 5 is very serious/continued/difficult
次要结局
未报告次要终点