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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502134
• Other study ID #: 201910004RIND
• Status: Recruiting
• Start date: November 30, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2020
• Source: National Taiwan University Hospital
• Contact: Chao Yuan-Hung, PhD
• Phone: 0933121572
• Email: yuanhungchao[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Rotator Cuff Tendinosis
• Tendinopathy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between ultrasound image and tendon tissue sectioning and staining	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	tendon-related transcription factors	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