B-ultrasound-guided Bending Needle and Thread Loop Carpal Tunnel Ligament Release in Carpal Tunnel Syndrome :Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively
研究概览
简要总结
Carpal tunnel syndrome is a set of symptoms and signs caused by compression of the median nerve within the carpal tunnel. The prevalence in the general population is about 3.72%, with a rising trend, making it the most common peripheral nerve entrapment syndrome. Compared to conservative treatment, surgical treatment has definite efficacy and lower recurrence rates, making it the ultimate choice for relieving median nerve compression. However, open surgery has disadvantages such as large trauma, long postoperative recovery period, and scar formation, while wrist arthroscopic surgery, although minimally invasive, is technically challenging, requires expensive specialized equipment, and has low cost-effectiveness, limiting its clinical application.
Therefore, based on clinical and life experience, our team innovatively developed the "Ultrasound-guided Needle Release of the Transverse Carpal Ligament." This technique avoids the risks of large trauma and scar formation associated with traditional open surgery, significantly shortens surgical and postoperative recovery times, and is more minimally invasive and cost-effective compared to wrist arthroscopic surgery, thus having high clinical value for promotion. This study aims to validate the effectiveness and safety of this innovative procedure through a single-arm interventional clinical study, providing a theoretical basis for further clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 40 and 70 years;
- •Exhibiting symptoms consistent with carpal tunnel syndrome (e.g., finger numbness, tingling, weakness, or pain; symptoms aggravated by repetitive or sustained gripping; symptoms worsening at night) and signs (sensory impairment or weakness in the hand; positive Tinel's sign or Phalen's test for the median nerve);
- •Meeting the diagnostic criteria for typical or possible carpal tunnel syndrome based on the Katz hand diagram for carpal tunnel syndrome [14];
- •Ultrasound indicating thickening of the transverse carpal ligament, compressing the median nerve;
- •Ineffective conservative treatment (e.g., immobilization, oral NSAIDs, local corticosteroid injections) for more than 3 months;
- •Signing the informed consent form.
排除标准
- •Ultrasound examination reveals bifurcation of the median nerve or the presence of a persistent median artery at the carpal tunnel entrance, or compression at the carpal tunnel caused by cysts, tumors, or fracture fragments;
- •Systemic infection or local infection at the surgical site;
- •Severe coagulation disorders;
- •Previous carpal tunnel syndrome surgery on the affected side for this operation;
- •Patients with uncontrolled epilepsy, cervical radiculopathy, or diabetic peripheral neuropathy;
- •Allergy to local anesthetics;
- •Inability to complete the questionnaire due to language or cognitive impairments;
- •Patients with severe heart, lung, liver, or brain diseases;
- •Patients with mental illnesses;
- •Participation in other clinical trials within the last three months;
- •Pregnant or breastfeeding women.
结局指标
主要结局
Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively
时间窗: 6 months post-operation
The Boston Carpal Tunnel Questionnaire (BCTQ) is considered an effective tool for assessing the severity of symptoms and functional status in carpal tunnel syndrome. It is divided into two parts: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 questions that evaluate the severity, frequency, and duration of symptoms. The FSS comprises 8 questions that assess the impact of the syndrome on daily life activities. Each question is scored from 0 (no symptoms or no impact) to 5 (most severe). The total score of the questionnaire is the average score of all questions.
次要结局
- Time to return to work(1, 2, and 4 weeks postoperative)
- Grip strength(before the surgery, 6 months postoperative)
- the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound(before the surgery, 6 months postoperative)
- quickDASH scale score(preoperative, 2 weeks, 3 months, and 6 months postoperative)
- Pinch strength(before the surgery, 6 months postoperative)