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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04859413
Other study ID # 202102043RINA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date September 2021

Study information

Verified date April 2021
Source National Taiwan University Hospital
Contact Chao Yuan-Hung, PhD
Phone 0933121572
Email yuanhungchao@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Previous studies used spatial frequency analysis of tendon ultrasound images and considered that the parameters can reflect the micro-structure of the tendon. In this study, we try to recruit and analysis the rotator cuff tendon in healthy adults with different ages and different equipment to explore the the normal range and differences of spatial frequency parameters. The hypotheses of this study are (1) the young and the elderly would have significantly different spatial frequency value; and (2) there would be significant different results between different equipment.


Description:

Tendons are hierarchical fibrous tissues. The speckle signals of ultrasonic images have parallel stripes arranged along the long axis of the tendon, reflecting the arrangement of collagen fiber bundles in the tendon. The micro-structure of tendons can be quantified by analyzing the speckle pattern of ultrasonic images. A research team used fast Fourier transform to convert ultrasound images of tendons into two-dimensional spatial frequency spectra, and used linear discriminate analysis to calculate multiple spatial frequency parameters. The results indicated that there were 5 parameters with the highest accuracy in discriminating Achilles tendinopathy. There is a significant difference in the spectrum frequency parameters of whether the tendon was loaded and whether there was a tendinopathy tendon. Past studies using spatial frequency analysis in patients with shoulder pain, and they found that there was no significant difference between the asymptomatic control group and shoulder pain patients. The risk factors of rotator cuff tendon injury is related advanced age, dominant hand, and repeated overhead activities. Therefore, in this study, we will recruit participants of different ages and investigate the results of spatial frequency analysis of bilateral shoulders ultrasound images. The aim of this study is to know whether these factors may affect the micro-structure of the rotator cuff tendons and establish the reference norm of spatial frequency analysis parameters in those without obvious tendon degeneration or injury. In addition, we aim to compare the differences between spectrum analysis parameters with several instruments by using different ultrasonic equipment. This study could provide a reference for the clinical application of spatial frequency analysis in tendon ultrasound images.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - (1) age between 20-40 or age over 60; - (2) no bilateral shoulder pain or discomfort within six months; - (3) no past diagnosis in shoulder or upper extremities. Exclusion Criteria: - (1) fracture of upper extremities before; - (2) be diagnosed as neck radiculopathy, central nervous system lesion of brain, or peripheral nervous system lesion of upper extremities; - (3) rheumatoid arthritis or autoimmune disease; - (4) have received any shoulder injection or surgery; - (5) tendon tear in shoulder sonograms.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary spatial frequency analysis parameters spatial frequency analysis in the ultrasound images of rotator cuff tendon Day 1
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