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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loop Carpal Tunnel Release group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyi Hou | Contact | 15920530546 | houjingyi246@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510235 | China |
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| 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 |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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