Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
NCT06440070

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

Age: 40Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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