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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032416
Receipt No. R000036961
Scientific Title Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Date of disclosure of the study information 2018/05/15
Last modified on 2019/06/25

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Basic information
Public title Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Acronym Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Scientific Title Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Scientific Title:Acronym Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Region
Japan

Condition
Condition chronic primary pain
Classification by specialty
Psychiatry Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To make an objective diagnostic and evaluation tool for chronic primary pain
Basic objectives2 Others
Basic objectives -Others prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum miRNA alterations before and after treatment
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 cognitive behavior therapy
Interventions/Control_2 total hip arthroplasty
Interventions/Control_3 healthy control
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) patients with pain over 3 months
2) 20 to 80 years old
3) consent to participate the study
Key exclusion criteria 1) patients with acute disease
2) alcohol or drug abuse
3) psychogenic disorder
4) suicidal thought
5) cognitive disorder
6) patients who do not speak Japanese
7) trauma
8) seeking compensation
9) pain rating is 10
10) contraindication for MRI
11) Those who have judged inappropriate for this research
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Nishie
Organization Kawasaki Medical School Hospital
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 7010192
Address 577 Matsushima Kurashiki Japan
TEL 0864621111
Email nishiehiroyuki@gmail.com

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Nishie
Organization Kawasaki Medical School Hospital
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 7010192
Address 577 Matsushima Kurashiki Japan
TEL 086-462-1111
Homepage URL
Email nishiehiroyuki@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Kawasaki Medical School
Address 577 Matsushima Kurashiki
Tel 0864621111
Email kenkyu-idai1@med.kawasaki-m.ac.jp

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
2018 Year 05 Month 15 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
2018 Year 05 Month 14 Day
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
2021 Year 03 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
2018 Year 04 Month 28 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036961

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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