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Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04502134
Collaborator
(none)
20
Enrollment
1
Location
22
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this project is to extract effusions and damaged tendons during tendon repair therapy in patients with tendon tears. Then, we would analyze tendon-related transcription factors from histology and cytology, and compare changes in tendon with ultrasound images. Helps to understand the mechanism of tendon lesions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    According to past studies, it is often observed that changes in extracellular matrix, growth factors, and cytokines in degenerative tendons, indicating that the tendon is constantly changing. This change will in turn produce a change in the morphology of the tendon tissue in the ultrasound image. However, there have been few studies in the past literature on the correlation between constant changes in tendon-specific transcription factors and characterization on clinical ultrasound images. Therefore, the purpose of this project is to extract the effusion and damaged tendon while performing tendon repair therapy in patients with tendon tears, and to analyze the tendon-related transcription factors from histology and cytology to understand the changes in tendon homeostasis. At the same time, the interpretation of clinical ultrasound images was combined to establish the relationship between the biochemical factors of the cell tissues of chronic tendon lesions and the clinical ultrasound image. This study will help us to understand the mechanism of chronic tendinopathy.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function
    Actual Study Start Date :
    Nov 30, 2019
    Anticipated Primary Completion Date :
    Apr 30, 2021
    Anticipated Study Completion Date :
    Sep 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. correlation between ultrasound image and tendon tissue sectioning and staining [Month 2]

      comparing the image of ultrasound and tendon tissue sectioning and staining to understand the tendon changing in micro stage while the defect could be singed on the ultrasound image

    Secondary Outcome Measures

    1. tendon-related transcription factors [Month 1]

      Tendon tissue sectioning and staining Immunohistochemical staining DNA microarray Tendon cell culture Flow cytometry Real-time quantitative reverse transcription polymerase chain reaction RNA-interference-mediated gene silencing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age older than 20 y

    • shoulder pain more than 3 months and Visual Analogue Scale (VAS) >4

    • shoulder tendon defect on ultrasound images

    Exclusion Criteria:

    • diagnosis of cervical radiculopathy or other central or peripheral neuropathy

    • rheumatoid arthritis or other autoimmune diseases

    • have received any shoulder joint injection within three months

    • tumor or systematic inflammation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100025

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04502134
    Other Study ID Numbers:
    • 201910004RIND
    First Posted:
    Aug 6, 2020
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    ultrasonography
    rotator cuff tendinopathy
    Additional relevant MeSH terms:
    Tendinopathy
    Rotator Cuff Injuries

    Study Results

    No Results Posted as of Nov 23, 2020