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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094778
• Other study ID #: ShenzhenPH Zhuang03
• Status: Completed
• Phase: N/A
• Start date: January 5, 2012
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2021
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: August 30, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• a single-portal palm approach
a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen People's Hospital	Hebei Medical University Third Hospital

References & Publications (1)

Shi Q, Bobos P, Lalone EA, Warren L, MacDermid JC. Comparison of the Short-Term and Long-Term Effects of Surgery and Nonsurgical Intervention in Treating Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Hand (N Y). 2020 Jan;15(1):13-22. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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