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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037917
Receipt No. R000043219
Scientific Title Effects of discomfort caused by sensorimotor incongruence on acute pain
Date of disclosure of the study information 2019/10/01
Last modified on 2021/05/09

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Basic information
Public title Effects of discomfort caused by sensorimotor incongruence on acute pain
Acronym sensorimotor incongruence and acute pain
Scientific Title Effects of discomfort caused by sensorimotor incongruence on acute pain
Scientific Title:Acronym sensorimotor incongruence and acute pain
Region
Japan

Condition
Condition Upper and lower limb fractures
Classification by specialty
Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of sensorimotor incongruence on pain
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain intensity 2 weeks and 1 month after fracture
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Flexion and extension exercises using a mirror every two weeks
Interventions/Control_2 Flexion and extension movements of the extremities using a mirror in an incongruence state. This is also done every two weeks.
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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Upper and kower limb fracture
Key exclusion criteria bilateral fracture
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Matsuda
Middle name
Last name Soichiro
Organization Kio university
Division name Graduate School of Health Science
Zip code 635-0832
Address 4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL 0745-54-1601
Email chocobaby.0802.26@gmail.com

Public contact
Name of contact person
1st name Osumi
Middle name
Last name Michihiro
Organization Kio university
Division name Graduate School of Health Science
Zip code 635-0832
Address 4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL 0745-54-1601
Homepage URL
Email m.ohsumi@kio.ac.jp

Sponsor
Institute Kio university
Institute
Department

Funding Source
Organization Kio 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 Kio university
Address 4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
Tel 0745-54-1601
Email chocobaby.0802.26@gmail.com

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
2019 Year 10 Month 01 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 30
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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
2020 Year 11 Month 18 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 09 Month 03 Day
Last modified on
2021 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043219

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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