UMIN-CTR Clinical Trial

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