A Prospective Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome: A Transform the Practice Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Strength testing of grip and pinch
研究概览
简要总结
To compare the incisionless thread carpal tunnel release with the standard mini-open carpal tunnel release (standard of care) in patients with bilateral carpal tunnel syndrome. Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release. The investigators hypothesize that the incisionless thread carpal tunnel release (TCTR) will be no different than the standard mini-open release (MOR) with regard to symptom improvement and safety and will be less painful, result in quicker return to work and will be less costly.
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 bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
- •Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release
- •Age 18-65 years of age
- •Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome.
- •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
- •Able and willing to complete all follow-up appointments
排除标准
- •Previous CTS surgical release on any of their hands
- •Diabetes mellitus
- •Hypothyroidism
- •Significant Hand arthritis (rheumatologic or osteoarthritis)
- •Pregnancy
- •Electromyographic evidence of any condition other than CTS affecting the hand
- •Workman's compensation
结局指标
主要结局
Strength testing of grip and pinch
时间窗: Change from Baseline to 12 months
Use dynameters and pinch meters
Visual analog pain scale
时间窗: Change from Baseline to 12 months
Pain that participant is currently experiencing the in the hand or risk(0-100)
Disability of the Arm Shoulder Hand DASH
时间窗: Change from Baseline to 12 months
he 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.
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score
时间窗: 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
研究者
Alexander Y. Shin, M.D.
Principal Investigator
Mayo Clinic