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

• Conditions: Rotator Cuff Tears; Rotator Cuff Tendinosis

• Registration Number: NCT04502134
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2019-11-30
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-23
• Primary Completion: 2021-04-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan