Clinical trial NCT06440070: Ultrasound-Guided Curved Needle Thread Carpal Tunnel Release: Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Surgery
Ultralsound-Guide
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 69
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively
timeFrame: 6 months post-operation
Secondary outcomes:
measure: quickDASH scale score
timeFrame: preoperative, 2 weeks, 3 months, and 6 months postoperative
measure: Grip strength
timeFrame: before the surgery, 6 months postoperative
measure: Pinch strength
timeFrame: before the surgery, 6 months postoperative
measure: the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound
timeFrame: before the surgery, 6 months postoperative
measure: Time to return to work
timeFrame: 1, 2, and 4 weeks postoperative
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: