UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040075 |
|---|---|
| Receipt number | R000045697 |
| Scientific Title | Development of evaluation and treatment of tissue around knee joint using ultrasonography |
| Date of disclosure of the study information | 2020/04/07 |
| Last modified on | 2024/01/23 13:26:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of new examination and treatment of joint function using ultrasonography
Acronym
Development of examination and treatment of joint using ultrasonography
Scientific Title
Development of evaluation and treatment of tissue around knee joint using ultrasonography
Scientific Title:Acronym
Evaluation and treatment of tissue around knee joint using ultrasonography
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changing of knee joint function using ultrasonography.
Basic objectives2
Others
Basic objectives -Others
Other data from ultrasound
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sliding distance of infra-patellar fat pad and medial patellar femoral ligament.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
manual therapy
Interventions/Control_2
physical stimulation
Interventions/Control_3
control
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students in our university
Key exclusion criteria
Participants who are informed and consented
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kitagawa |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
390-0813
Address
3-1-1, Asahi
TEL
0263-37-2413
tkitagawa@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kitagawa |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
390-0813
Address
Nagano, Matsumoto, 3-1-1, Asahi
TEL
0263-37-2413
Homepage URL
tkitagawa@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
Nagano, Matsumoto, 3-1-1, Asahi
Tel
0263-37-2413
tkitagawa@shinshu-u.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
| 2020 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1371/journal.pone.0265333
Number of participants that the trial has enrolled
64
Results
In this randomised controlled trial, 64 healthy young participants were enrolled and randomly assigned to one of the following three interventions: manual therapy, hot pack treatment, and control. The thickness change ratio of the infrapatellar fat pad was calculated to compare the changes between and within groups before and after the intervention. No significant inter-group differences were observed.
Results date posted
| 2024 | Year | 01 | Month | 23 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
