A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release

Study Overview
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Brief Summary
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Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.

Detailed Description
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Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Official Title
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A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: a single-portal palm approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand Symptoms of carpal tunnel syndrome had lasted>2 months or inadequate responses to the non-surgical treatments≥3 months moderate to severe symptoms. Exclusion Criteria: mild symptoms or prior injuries to the extremity bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single-portal group<br>The patients in single-portal group were treated with single-portal palm approach | Procedure: a single-portal palm approach<br>* a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensibility of the pulps of thumb, index finger, and middle finger (mm) | static 2-point discrimination (2PD) test is used for testing the sensibility of the pulps of digits. The range of normal value is 3 mm--5 mm, and higher scores mean a worse outcome | 3 years | 
| Severity of symptoms and functional status | The Levine Questionnaire is regarded as a valuable assessment of severity of symptoms and functional status in carpal tunnel syndrome. It is self-administered and is in two sections. The symptoms severity scale is 11 questions and evaluates symptoms regarding severity, frequency, time and kind. The functional status scale is eight questions and evaluates how the syndrome affects daily life.Each question had five ordinal response categories ranging from 1 (no symptoms) to 5 (very severe symptoms). Responses to individual items were averaged to yield an overall score for each scale. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal tunnel syndrome, carpal tunnel release, pain, nerve compression syndromes