UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038967 |
|---|---|
| Receipt number | 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 01:57:14 |
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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
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
kgsm.1ga@gmail.com
Sponsor or person
Institute
Kio University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044410
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
