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

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called "Ultrasound-Guided Needle Release of the Transverse Carpal Ligament" to treat carpal tunnel syndrome, which occurs when the median nerve in the wrist is compressed, causing symptoms like numbness, tingling, and weakness in the hand. This innovative technique aims to be less invasive than traditional surgery, reducing pain and recovery time while avoiding large scars. The study is designed to confirm how effective and safe this new method is compared to standard treatments.

To be eligible for the trial, participants should be between 40 and 70 years old and have symptoms of carpal tunnel syndrome that have not improved after trying other treatments for at least three months. Participants will need to sign a consent form and may undergo an ultrasound to confirm their condition. The trial is currently recruiting, and anyone interested should discuss their eligibility with their healthcare provider. Overall, this trial could provide a promising new option for managing carpal tunnel syndrome effectively and safely.

Gender

ALL

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.