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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030228
Receipt No. R000034527
Scientific Title Visualization and quantification of low back pain with functional MRI
Date of disclosure of the study information 2017/12/04
Last modified on 2019/06/04

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Basic information
Public title Visualization and quantification of low back pain with functional MRI
Acronym Visualization of low back pain with fMRI
Scientific Title Visualization and quantification of low back pain with functional MRI
Scientific Title:Acronym Visualization of low back pain with fMRI
Region
Japan

Condition
Condition Patients with low back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To visualize and quantify low back pain of
patients with degenerative lumbar disease
using functional MRI
Basic objectives2 Others
Basic objectives -Others Comparison of functional MRI results between lumbar discogenic pain and myofascial low back pain
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visualization and quantification of low back pain using functional MRI
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 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Functional MRI of patients with low back
pain (30 minutes)
Interventions/Control_2 Functional MRI of volunteers without low back pain (30 minutes)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1-1. Patients with low back pain occurred by degenerative lumbar disease
1-2. Volunteers without low back pain
2. Patients and volunteers with agreement of informed consent
Key exclusion criteria 1. Patients and volunteers who physician has determined that improper
2. Patients and volunteers with disagreement of informed consent
3. Patients and volunteers with contraindication of MRI scan
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Go
Middle name
Last name Yoshida
Organization Hamamatsu University School of Medicine
Division name Department of Orthopedics
Zip code 431-3192
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2299
Email goy@k6.dion.ne.jp

Public contact
Name of contact person
1st name Go
Middle name
Last name Yoshida
Organization Hamamatsu University School of Medicine
Division name Department of Orthopedics
Zip code 431-3192
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2299
Homepage URL
Email goy@k6.dion.ne.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
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 Hamamatsu Univerisity School of Medicine
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, 431-3192, Japan
Tel 0534352299
Email rinri@hama-med.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
2017 Year 12 Month 04 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
2017 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
2021 Year 08 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
2017 Year 12 Month 02 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034527

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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