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

NCT ID: NCT06440070

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loop Carpal Tunnel Release group

Group Type: EXPERIMENTAL

Loop Carpal Tunnel Release

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged between 40 and 70 years;

2. 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);

3. Meeting the diagnostic criteria for typical or possible carpal tunnel syndrome based on the Katz hand diagram for carpal tunnel syndrome [14];

4. Ultrasound indicating thickening of the transverse carpal ligament, compressing the median nerve;

5. Ineffective conservative treatment (e.g., immobilization, oral NSAIDs, local corticosteroid injections) for more than 3 months;

6. Signing the informed consent form.

Exclusion Criteria

1. 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;

2. Systemic infection or local infection at the surgical site;

3. Severe coagulation disorders;

4. Previous carpal tunnel syndrome surgery on the affected side for this operation;

5. Patients with uncontrolled epilepsy, cervical radiculopathy, or diabetic peripheral neuropathy;

6. Allergy to local anesthetics;

7. Inability to complete the questionnaire due to language or cognitive impairments;

8. Patients with severe heart, lung, liver, or brain diseases;

9. Patients with mental illnesses;

10. Participation in other clinical trials within the last three months;

11. Pregnant or breastfeeding women.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingyi Hou

Role: CONTACT

houjingyi246@126.com

15920530546

Facility Contacts

Jingyi Hou

Role: primary

houjingyi246@126.com

15920530546

Other Identifiers

SYSKY-2024-287-02

Identifier Type: -

Identifier Source: org_study_id