Ultrasound-guided carpal tunnel release procedure

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

This study is testing a new ultrasound-guided method for treating carpal tunnel syndrome to see if it can help patients recover faster and with less pain than traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06440070 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of an innovative ultrasound-guided technique for releasing the transverse carpal ligament in patients with carpal tunnel syndrome. The approach aims to minimize trauma and postoperative recovery time compared to traditional surgical methods. Participants will undergo the loop carpal tunnel release procedure if they meet specific eligibility criteria, including age and symptom severity. The study focuses on patients who have not responded to conservative treatments for their condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 70 who exhibit symptoms of carpal tunnel syndrome and have not found relief through conservative treatments.

Not a fit: Patients with specific anatomical variations or severe nerve compression that cannot be addressed by this technique may not benefit from the procedure.

Why it matters

Potential benefit: If successful, this technique could provide a less invasive and more effective treatment option for patients suffering from carpal tunnel syndrome.

How similar studies have performed: While similar minimally invasive techniques have shown promise, this specific ultrasound-guided approach is relatively novel and has not been widely tested.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jingyi Hou

Conditions Carpal Tunnel Syndrome; Surgery; Ultralsound-Guide