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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a single-portal palm approach
Sponsored by
Shenzhen People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, carpal tunnel release, pain, nerve compression syndromes

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    single-portal group

    Arm Description

    The patients in single-portal group were treated with single-portal palm approach

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2021
    Last Updated
    October 15, 2021
    Sponsor
    Shenzhen People's Hospital
    Collaborators
    Hebei Medical University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05094778
    Brief Title
    A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release
    Official Title
    A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2012 (Actual)
    Primary Completion Date
    June 15, 2021 (Actual)
    Study Completion Date
    August 30, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shenzhen People's Hospital
    Collaborators
    Hebei Medical University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome
    Keywords
    Carpal tunnel syndrome, carpal tunnel release, pain, nerve compression syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    192 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    single-portal group
    Arm Type
    Other
    Arm Description
    The patients in single-portal group were treated with single-portal palm approach
    Intervention Type
    Procedure
    Intervention Name(s)
    a single-portal palm approach
    Intervention Description
    a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.
    Primary Outcome Measure Information:
    Title
    The sensibility of the pulps of thumb, index finger, and middle finger (mm)
    Description
    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
    Title
    Severity of symptoms and functional status
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yongqing Zhuang
    Organizational Affiliation
    Shenzhen People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30015499
    Citation
    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: 10.1177/1558944718787892. Epub 2018 Jul 17.
    Results Reference
    result

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

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