Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Boston Carpal Tunnel Questionnaire
研究概览
简要总结
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.
Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.
详细描述
Background: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper limb, with a prevalence of around 1'14% and 14'4% of the population.
The clinical symptoms are usually pain, paresthesias and numbness on the sensitive distribution territory of the median nerve in the hand.
Conservative treatment is used for the mild cases, and surgery for the moderate and severe ones, or when the conservative treatment has failed.
Open carpal tunnel release is the gold standard surgery, with a short longitudinal volar approach that allows to visualize the complete division of the ligament.
Over the last few years, endoscopic techniques have been introduced, offering some advantages such as: lower postoperative pain, earlier return to work and less complications due to the wound. Despite this, it has not been popularised, probably, because it is a challenging and more expensive surgical procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old.
- •Positive electromyography, confirming carpal tunnel syndrome.
- •Capable to understand risks and advantages of both procedures.
- •Normal blood tests.
排除标准
- •Previous carpal tunnel release in the same hand.
- •Previous fracture or dislocation in the area around the forearm, wrist or hand.
- •Signs or symptoms of infection.
- •Psychiatric disorders.
- •Antiplatelet or anticoagulant therapy, that cannot be suspended due to underlying pathology, and does not allow the surgery to be performed.
- •Coagulation disorders, or any underlying pathology, with high risk of thrombosis or bleeding.
研究组 & 干预措施
Open surgery
30 patients will be operated with an open carpal tunnel release.
干预措施: Open surgery (Procedure)
Percutaneous surgery
30 patients will be operated with a percutaneous carpal tunnel release.
干预措施: Percutaneous surgery (Procedure)
结局指标
主要结局
Change in Boston Carpal Tunnel Questionnaire
时间窗: Preoperative, 4 weeks and 24 weeks after surgery.
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale. The range of the final results are from 19 (no symptoms) to 95 (severe symptoms).
次要结局
- Time off work(24 weeks after surgery.)
- Grip strength(Preoperative, 4 weeks and 24 weeks after surgery.)
- Quick-DASH (Disabilities of Arm, Shoulder and Hand)(Preoperative, 4 weeks and 24 weeks after surgery.)
- Visual Numeric Scale(Preoperative, 4 weeks and 24 weeks after surgery.)
- Douleur Neuropathique 4 questions (DN4)(Preoperative, 4 weeks and 24 weeks after surgery.)
- Consumer Reports Effectiveness Scale (CRES-4)(24 weeks after surgery.)
- Number of other complications(4 weeks and 24 weeks after surgery.)
研究者
Javier Coloma
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana