UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058101 |
|---|---|
| Receipt number | R000066403 |
| Scientific Title | Verification of the accuracy of a newly developed muscle stiffness meter and diagnostic research on muscle-related pathologies and muscle stiffness |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/12/26 15:02:37 |
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Basic information
Public title
Verification of the accuracy of a newly developed muscle stiffness meter and diagnostic research on muscle-related pathologies and muscle stiffness
Acronym
Verification of the accuracy of a newly developed muscle stiffness meter and diagnostic research on muscle-related pathologies and muscle stiffness
Scientific Title
Verification of the accuracy of a newly developed muscle stiffness meter and diagnostic research on muscle-related pathologies and muscle stiffness
Scientific Title:Acronym
Verification of the accuracy of a newly developed muscle stiffness meter and diagnostic research on muscle-related pathologies and muscle stiffness
Region
| Japan |
Condition
Condition
neck stiffness, muscle stiffness, muscle strain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical significance and usefulness of muscle stiffness, and to evaluate its practicality in sports medicine, rehabilitation, and industrial medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of changes in muscle stiffness before and after exercise, and the accuracy of the muscle stiffness meter compared to elastography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Measurement of muscle stiffness, physical examination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults without pain at the measurement site
Key exclusion criteria
People who have pain at the measurement site
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshimi |
| Middle name | |
| Last name | Aizawa |
Organization
Tohoku University
Division name
Department of Orthopaedic Surgery, Tohoku University School of Medicine.
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 , JAPAN
TEL
022-717-7248
tohokuseikei@e-mail.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Onoki |
Organization
Tohoku University
Division name
Department of Orthopaedic Surgery, Tohoku University School of Medicine.
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 , JAPAN
TEL
022-717-7248
Homepage URL
takahiro.onoki.d4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.ac.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
| 2025 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066403
