UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047624 |
|---|---|
| Receipt number | R000053935 |
| Scientific Title | A study of "Katakori" |
| Date of disclosure of the study information | 2022/04/29 |
| Last modified on | 2023/11/22 16:53:25 |
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Basic information
Public title
A study of "Katakori"
Acronym
"Katakori" study
Scientific Title
A study of "Katakori"
Scientific Title:Acronym
"Katakori" study
Region
| Japan |
Condition
Condition
Shoulder and Neck Pain (so called "Katakori")
Drop head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Define of the "Katakori"
Investigation of the factors about "Katakori"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the healthy indexes after treatment
Key secondary outcomes
Investigate of the muscle stiffness after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Behavior,custom |
Interventions/Control_1
Healthy volunteer
Interventions/Control_2
No treatment for Drop head
Interventions/Control_3
Treated for Katakori
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
Healthy volunteer
Key exclusion criteria
Having spinal disease and shoulder disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshimi |
| Middle name | |
| Last name | Aizawa |
Organization
Tohoku University Hospital
Division name
Orthopaedic department
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 , JAPAN
TEL
022-717-7245
toshi-7@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Onoki |
Organization
Tohoku University Hospital
Division name
Orthopaedic department
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 , JAPAN
TEL
022-717-7245
Homepage URL
takahiro.onoki.d8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Orthopaedic Surgery, Tohoku University School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 , JAPAN
Tel
022-717-7245
takahiro.onoki.d8@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
| 2022 | Year | 04 | Month | 29 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053935
