UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011262
Receipt number R000013119
Scientific Title A study to elucidate pathologic specificity in the patients with chronic pain using MRI
Date of disclosure of the study information 2013/07/25
Last modified on 2017/07/27 09:44:16

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Basic information

Public title

A study to elucidate pathologic specificity in the patients with chronic pain using MRI

Acronym

Chronic pain and MRI

Scientific Title

A study to elucidate pathologic specificity in the patients with chronic pain using MRI

Scientific Title:Acronym

Chronic pain and MRI

Region

Japan


Condition

Condition

Fibromyalgia, low back pain or postherpetic neuralgia (PHN)

Classification by specialty

Neurology Clinical immunology Orthopedics
Anesthesiology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate central nervous sysytem connectivity using fMRI in the patients with chronic pain.

Basic objectives2

Others

Basic objectives -Others

central nervous sysytem connectivity

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

connectivity

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

MRI

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

chronic pain (fibromyalgia, low back pain, PHN)

Key exclusion criteria

CNS dysfunction

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Inomata

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Anesthesiology

Zip code


Address

Tennnoudai 1-1-1, Tsukuba City, Ibaraki, Japan

TEL

029-853-3525

Email

inomatas@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Inomata

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Anesthesiology

Zip code


Address

Tennnoudai 1-1-1, Tsukuba City, Ibaraki, Japan

TEL

029-853-3525

Homepage URL


Email

inomatas@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

筑波大学附属病院


Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 25 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

Completed

Date of protocol fixation

2013 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 24 Day

Last modified on

2017 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name