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Effectiveness and Safety of Ultrasound-Guided Loop Carpal Tunnel Release vs. Open Carpal Tunnel Release for Carpal Tunnel Syndrome: A Multicenter, Randomized Controlled Trail

Effectiveness and Safety of Ultrasound-Guided Loop Carpal Tunnel Release vs. Open Carpal Tunnel Release for Carpal Tunnel Syndrome: A Multicenter, Randomized Controlled Trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096328
Enrollment
Unknown
Registered
2025-01-21
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carpal tunnel syndrome

Interventions

Loop Carpal Tunnel Release Group:Undergoing Ultrasound-guided Loop Carpal Tunnel Release surgery
Open Carpal Tunnel Release Group:Undergoing Open Carpal Tunnel Release surgery

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1)Aged 40–70 years; (2)Exhibiting typical symptoms of carpal tunnel syndrome (e.g., finger numbness, tingling, weakness, or pain; symptoms aggravated by repetitive or sustained gripping; worsening symptoms at night) and typical signs (e.g., sensory deficits or weakness in the hand; positive Tinel's sign or Phalen's test for the median nerve); (3)Meeting the criteria for typical or possible carpal tunnel syndrome based on the Katz hand diagram diagnostic standards; (4)Electromyography indicating abnormalities of the median nerve; (5)Ultrasound revealing thickening of the transverse carpal ligament and compression of the median nerve; (6)Ineffective conservative treatments (e.g., immobilization, oral NSAIDs, local corticosteroid injections) for more than 3 months; (7)Able to understand the study process, willing to participate in the study, capable of completing a 2-year postoperative follow-up, and providing informed consent; (8)Normal or near-normal coagulation function tests (based on the normal range values of each research center's laboratory): a. Prothrombin time (PT) prolonged by =3 seconds and b. Activated partial thromboplastin time (APTT) prolonged by =10 seconds.

Exclusion criteria

Exclusion criteria: (1)Ultrasound findings indicating bifurcation of the median nerve or a persistent median artery at the carpal tunnel entry, or compression of the carpal tunnel caused by cysts, tumors, or fracture fragments; (2)Systemic infection or localized infection at the surgical site; (3)Previous surgery for carpal tunnel syndrome on the affected side being treated; (4)Patients with uncontrolled epilepsy, cervical radiculopathy, or diabetic peripheral neuropathy; (5)Allergy to local anesthetics; (6)Inability to complete questionnaire assessments due to language or cognitive impairments; (7)Pregnant or breastfeeding women; (8)Severe cardiac disease or conditions rendering the patient unable to tolerate surgery, including but not limited to: Fatal arrhythmias or high-grade atrioventricular block, Unstable angina, Clinically significant valvular heart disease, Electrocardiographic evidence of transmural myocardial infarction, Uncontrolled hypertension; (9)Any other condition deemed by the researcher to make the patient unsuitable for participation in the study, such as coexisting diseases or conditions that may interfere with study participation or pose a serious medical risk to the subject (e.g., psychiatric disorders, uncontrolled heart disease, hypertension, active or uncontrolled infections).

Design outcomes

Primary

MeasureTime frame
Boston carpal tunnel questionnaire symptom severity scale scores;Boston carpal tunnel questionnaire functional status scale scores;

Secondary

MeasureTime frame
Quick Disabilities of the Arm, Shoulder and Hand scores;12-Item Short-Form Health Survey (SF-12);Grip strength;Pinch strength;Ultrasound measurement of the cross-sectional area of the median nerve at the proximal inlet of the carpal tunnel;Visual analogue scale scores;Hospitalization costs;Length of stay;

Countries

China

Contacts

Public ContactHou Jingyi

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

houjingyi246@126.com+86 181 0276 9380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026