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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Loop Carpal Tunnel Release

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyi Hou; Phone Number: 15920530546; Email: houjingyi246@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510235
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Jingyi Hou; Phone Number: 15920530546; Email: houjingyi246@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loop Carpal Tunnel Release group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
quickDASH scale score	The change in Quick Disabilities of the Arm, Shoulder and Hand (quickDASH) scores from preoperative to 2 weeks, 3 months, and 6 months postoperative. Researchers will ask the enrolled patients the questionnaire either in person, over the phone, or online, then record the answers, summarize, and document the scores.	preoperative, 2 weeks, 3 months, and 6 months postoperative
Grip strength	The change in grip strength from before the surgery to 6 months postoperative. Researchers will explain the use of the dynamometer to the patients, assist them in measuring their grip strength, and record the dynamometer readings.	before the surgery, 6 months postoperative
Pinch strength	The change in pinch strength from before the surgery to 6 months postoperative. Researchers will explain the use of the dynamometer to the patients, assist them in measuring their pinch strength, and record the dynamometer readings.	before the surgery, 6 months postoperative
the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound	The comparison of the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound between preoperative and 6 months postoperative. This will be examined and reported by the Ultrasound Department of our hospital.	before the surgery, 6 months postoperative
Time to return to work	The time to return to work after surgery is defined as the number of days from the day of surgery to the first day the patient returns to their preoperative job or is able to fully resume daily activities. This is self-assessed by the patient, and researchers will ask and record the information at 1, 2, and 4 weeks postoperative.	1, 2, and 4 weeks postoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Carpal Tunnel Syndrome; Ultralsound-Guide
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: SYSKY-2024-287-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No