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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028053
Receipt No. R000031794
Scientific Title Establishment of objective evaluation method of knee pain relaxation effect by tender point stretching
Date of disclosure of the study information 2017/07/03
Last modified on 2018/07/04

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Basic information
Public title Establishment of objective evaluation method of knee pain relaxation effect by tender point stretching
Acronym Establishment of objective evaluation method of knee pain
Scientific Title Establishment of objective evaluation method of knee pain relaxation effect by tender point stretching
Scientific Title:Acronym Establishment of objective evaluation method of knee pain
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of objective evaluation method of knee pain relaxation effect by tender point stretching
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes functional mri right after tender point stretching
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 tender point stretching
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria knee pain and no knee pain
Key exclusion criteria dementia
low consciousness level
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Katagiri
Organization Tokyo Medical and Dental University
Division name Department of Joint Surgery and Sports Medicine,
Zip code
Address 1-5-45 yushima bunkyouku tokyo
TEL 03-5803-4675
Email katagiri.orj@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Katagiri
Organization Tokyo Medical and Dental University
Division name Department of Joint Surgery and Sports Medicine,
Zip code
Address 1-5-45 yushima bunkyouku tokyo
TEL 03-5803-4675
Homepage URL
Email katagiri.orj@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 Month 03 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
2017 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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