Actively Recruiting
Ultrasound-Guided Curved Needle Thread Carpal Tunnel Release: Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-06-07
69
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ultrasound-Guided Curved Needle Thread Carpal Tunnel Release: Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 40 and 70 years
- Symptoms such as finger numbness, tingling, weakness, or pain worsened by repetitive gripping or at night
- Signs including sensory impairment or weakness in the hand, positive Tinel's or Phalen's test for the median nerve
- Diagnosis of typical or possible carpal tunnel syndrome based on the Katz hand diagram
- Ultrasound shows thickening of the transverse carpal ligament compressing the median nerve
- Conservative treatments like immobilization, NSAIDs, or corticosteroid injections tried for more than 3 months without success
- Signed informed consent form
You will not qualify if you...
- Ultrasound shows median nerve bifurcation, persistent median artery, or compression caused by cysts, tumors, or fracture fragments
- Systemic or local infection at the surgical site
- Severe coagulation disorders
- Previous carpal tunnel surgery on the affected wrist
- Uncontrolled epilepsy, cervical radiculopathy, or diabetic peripheral neuropathy
- Allergy to local anesthetics
- Unable to complete questionnaires due to language or cognitive issues
- Severe heart, lung, liver, or brain diseases
- Mental illness
- Participation in other clinical trials within the last 3 months
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510235
Actively Recruiting
Research Team
J
Jingyi Hou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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