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

NCT06440070 | Recruiting

• 1 other identifier: SYSKY-2024-287-02
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Surgery; Ultralsound-Guide

Outcome Measures

Primary Outcomes (1)

• Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively

  The Boston Carpal Tunnel Questionnaire (BCTQ) is considered an effective tool for assessing the severity of symptoms and functional status in carpal tunnel syndrome. It is divided into two parts: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 questions that evaluate the severity, frequency, and duration of symptoms. The FSS comprises 8 questions that assess the impact of the syndrome on daily life activities. Each question is scored from 0 (no symptoms or no impact) to 5 (most severe). The total score of the questionnaire is the average score of all questions.

  6 months post-operation

Secondary Outcomes (5)

• quickDASH scale score

  preoperative, 2 weeks, 3 months, and 6 months postoperative

• Grip strength

  before the surgery, 6 months postoperative

• Pinch strength

  before the surgery, 6 months postoperative

• the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound

  before the surgery, 6 months postoperative

• Time to return to work

  1, 2, and 4 weeks postoperative

Study Arms (1)

Loop Carpal Tunnel Release group

EXPERIMENTAL

Procedure: Loop Carpal Tunnel Release

Interventions

Loop Carpal Tunnel Release PROCEDURE

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.

Loop Carpal Tunnel Release group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510235, China

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Jingyi Hou

CONTACT

15920530546; houjingyi246@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CN (1)