An interventional study of a single-portal palm approach in Carpal Tunnel Syndrome, sponsored by Shenzhen People's Hospital. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Shenzhen People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 192 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Shenzhen People's Hospital is the lead sponsor of 62 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
The patients in single-portal group were treated with single-portal palm approach
Procedure: a single-portal palm approach
a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.
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
Time frame: 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.
Time frame: 3 years
No study locations are listed for this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Shenzhen People's Hospital