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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: a single-portal palm approach

• Registration Number: NCT05094778
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01-05
• Primary Completion: 2021-06-15
• Study Completion: 2021-08-30
• Status Verified: 2021-10
• Study First Submitted: 2021-10-02
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-portal group	a single-portal palm approach	The patients in single-portal group were treated with single-portal palm approach

Primary Outcome Measures

Name	Time	Method
The sensibility of the pulps of thumb, index finger, and middle finger (mm)	3 years	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
Severity of symptoms and functional status	3 years	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.