Ultrasound-Guided Curved Needle Thread Carpal Tunnel Release: Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Loop Carpal Tunnel Release
  Under the guidance of ultrasound, needles are inserted above and below the transverse carpal ligament, respectively, to form a loop around the ligament. Finally, the ligament is cut by pulling the looped thread.

Первичные конечные точки

• Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively [Срок оценки: 6 months post-operation]

Вторичные конечные точки (5)

• quickDASH scale score [Срок оценки: preoperative, 2 weeks, 3 months, and 6 months postoperative]
• Grip strength [Срок оценки: before the surgery, 6 months postoperative]
• Pinch strength [Срок оценки: before the surgery, 6 months postoperative]
• the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound [Срок оценки: before the surgery, 6 months postoperative]
• Time to return to work [Срок оценки: 1, 2, and 4 weeks postoperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06440070 · SYSKY-2024-287-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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