UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063520 |
|---|---|
| Receipt number | R000072698 |
| Scientific Title | Limited Reliability and Agreement of Shear Wave Elastography for Assessing Achilles Tendon Stiffness Despite a Standardized Protocol |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 08:59:08 |
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Basic information
Public title
Limited Reliability and Agreement of Shear Wave Elastography for Assessing Achilles Tendon Stiffness Despite a Standardized Protocol
Acronym
Limited Reliability and Agreement of Shear Wave Elastography for Assessing Achilles Tendon Stiffness Despite a Standardized Protocol
Scientific Title
Limited Reliability and Agreement of Shear Wave Elastography for Assessing Achilles Tendon Stiffness Despite a Standardized Protocol
Scientific Title:Acronym
Limited Reliability and Agreement of Shear Wave Elastography for Assessing Achilles Tendon Stiffness Despite a Standardized Protocol
Region
| Japan |
Condition
Condition
Achilles tendinopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the intra- and inter-rater reliability of Achilles tendon stiffness measurements using ultrasound elastography.
Basic objectives2
Others
Basic objectives -Others
Two examiners will perform ultrasound elastography measurements on each participant, and the reliability of both qualitative and quantitative assessments will be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shear wave velocity
Key secondary outcomes
Young modulus
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No Achilles tendon pain
Key exclusion criteria
A history of lower-extremity tendon injury or pathology, a history of foot or ankle surgery, inflammatory diseases, dyslipidemia, diabetes mellitus, and a history of fluoroquinolone antibiotic use
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Graduate School of Global and Transdisciplinary Studies, Chiba University, Chiba, Japan
Division name
Orthopediacs
Zip code
263-8522
Address
1-33 Yayoicho, Inage-ku, Chiba-shi, Chiba
TEL
043-226-2117
h.nakaji.0828@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Division name
Orthopediacs
Zip code
260-8677
Address
1-8-1 inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
y-satoshi@mvb.biglobe.ne.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba university
Address
1-8-1 inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
y-satoshi@faculty.chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Intraclass correlation coefficient point estimates ranged from 0.47 to 0.85, whereas lower 95% confidence limits ranged from -0.82 to 0.50 in controls, patients, and the total sample. Thus, no analysis met the predefined acceptable thresholds. Bland-Altman plots showed no evident systematic error. However, the 95% limits of agreement ranged from -4.0 to 5.6 m/s for shear wave velocity and from -172.9 to 211.5 kPa for Young's modulus, substantially exceeding the predefined acceptable thresholds.
Results date posted
| 2026 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Twelve controls and 12 patients with mid-portion Achilles tendinopathy underwent shear wave elastography assessment.
Participant flow
Adverse events
None
Outcome measures
Shear wave velocity and Young modulus
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072698
