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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038967
Receipt No. R000044410
Scientific Title The effect of fear of pain on kinematic data: focusing on the psychological characteristics of individual
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/24

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Basic information
Public title The effect of fear of pain on motor:focusing on individual psychology characteristics
Acronym motor due to fear of pain
Scientific Title The effect of fear of pain on kinematic data: focusing on the psychological characteristics of individual
Scientific Title:Acronym Kinematic data due to fear of pain
Region
Japan

Condition
Condition adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to clarify the psychological characteristics of an individual through kinematic analysis of fear caused by pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain catastrophizing scale(PCS)
velocity
muscle activity (root mean square)
Fear of pain questionarie-3(FPQ-3)
hospital anxiety and depression scale(HADS)
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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 pain-induced the electrical stimulator
wireless electromyograph system
Magnetic 3 dimesion analysis system
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
50 years-old >=
Gender Male and Female
Key inclusion criteria healthy person without dysfunction or pain in dominant hand.
Key exclusion criteria unable to obtain research consent.
have dominant dysfunction or acute or chronic pain.
participants with orthopedic disorder,paralysis,problems with muscles or joints in the dominant upper limb.
participants with pacemakers,respiratory disorders,neurological disorders,pregnancy,mental disorders.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Igawa
Organization Kio University Graduate School
Division name Kio university Graduate School Neuro rehabilitation research center
Zip code 6350832
Address 4-2-2 Umaminaka, Koryo-cho, Kitatsukatsugi-gun, Nara Prefecture
TEL 08039835404
Email kgsm.1ga@gmail.com

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Igawa
Organization Kio University Graduate School
Division name Kio university Graduate School Neuro rehabilitation research center
Zip code 6350832
Address 4-2-2 Umaminaka, Koryo-cho, Kitatsukatsugi-gun, Nara Prefecture
TEL 08039835404
Homepage URL
Email kgsm.1ga@gmail.com

Sponsor
Institute Kio University Graduate School
Institute
Department

Funding Source
Organization Kio University Graduate School
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 Graduate School
Address 4-2-2 Umaminaka, Koryo-cho, Kitatsukatsugi-gun, Nara Prefecture
Tel 08039835404
Email kgsm.1ga@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
2020 Year 01 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
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
2019 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2021 Year 01 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
2019 Year 12 Month 24 Day
Last modified on
2019 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044410

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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