- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502134
Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function
November 20, 2020 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chao Yuan-Hung, PhD
- Phone Number: 0933121572
- Email: yuanhungchao@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100025
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Chao Yuan-Hung, PhD
- Phone Number: 0933121572
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Ultrasound diagnosis of damage to the shoulder rotator tendon, calcification, acromion bursitis or viscous shoulder capsule
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between ultrasound image and tendon tissue sectioning and staining
Time Frame: 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
|
Month 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tendon-related transcription factors
Time Frame: 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
|
Month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2019
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
September 30, 2021
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201910004RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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