Rotator Cuff InjuriesNCT04859413
Frequency Analysis of the Ultrasound Images in Rotator Cuff Tendon
An observational study of Rotator Cuff Injuries, run by National Taiwan University Hospital.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Injuries
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Injuries
- Keywords
- ultrasonography, rotator cuff tendon
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the young group | healthy participants age between 20 and 40 | |
| the elder group | healthy participants age over 60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
spatial frequency analysis parameters
spatial frequency analysis in the ultrasound images of rotator cuff tendon
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Yuan-Hung, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859413
- Sponsor's protocol ID
- 202102043RINA
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Analysis of the Ultrasound Images in Rotator Cuff Tendon
- ClinicalTrials.gov ID
- NCT04859413
- Acronym / sponsor ID
- 202102043RINA
- Conditions
- Rotator Cuff Injuries
- Keywords
- ultrasonography, rotator cuff tendon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the young group | – | –healthy participants age between 20 and 40 |
| the elder group | – | –healthy participants age over 60 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
spatial frequency analysis parameters
Time frame: Day 1
spatial frequency analysis in the ultrasound images of rotator cuff tendon
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Yuan-Hung, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Yuan-Hung, PhD (0933121572, yuanhungchao@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spatial frequency analysis parameters (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.