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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05094778
Enrollment
192
Registered
2021-10-26
Start date
2012-01-05
Completion date
2021-08-30
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndrome, carpal tunnel release, pain, nerve compression syndromes

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.

Interventions

PROCEDUREa single-portal palm approach

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

Sponsors

Hebei Medical University Third Hospital
CollaboratorOTHER
Shenzhen People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The sensibility of the pulps of thumb, index finger, and middle finger (mm)3 yearsstatic 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 status3 yearsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026