Ultrasound-Guided Curved Needle Thread Carpal Tunnel Release: Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Loop Carpal Tunnel Release.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively [Time frame: 6 months post-operation]
Secondary outcome measures (5)
- quickDASH scale score [Time frame: preoperative, 2 weeks, 3 months, and 6 months postoperative]
- Grip strength [Time frame: before the surgery, 6 months postoperative]
- Pinch strength [Time frame: before the surgery, 6 months postoperative]
- the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound [Time frame: before the surgery, 6 months postoperative]
- Time to return to work [Time frame: 1, 2, and 4 weeks postoperative]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06440070 · SYSKY-2024-287-02