- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04859413
Frequency Analysis of the Ultrasound Images in Rotator Cuff Tendon
April 22, 2021 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
40
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
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adults from NTUH rehabilitation outpatient department, from NTU, or adults in connection with colleagues in the NTUH rehabilitation department or School and Graduate Institute of Physical Therapy in Collage of Medicine of NTU.
Description
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 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
Cohorts and Interventions
Group / Cohort |
|---|
|
the young group
healthy participants age between 20 and 40
|
|
the elder group
healthy participants age over 60
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
spatial frequency analysis parameters
Time Frame: Day 1
|
spatial frequency analysis in the ultrasound images of rotator cuff tendon
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chao Yuan-Hung, PhD, National Taiwan University Hospital
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 (Anticipated)
April 1, 2021
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
April 19, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Actual)
April 26, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202102043RINA
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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-
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