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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023604
Receipt No. R000027176
Scientific Title Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study
Date of disclosure of the study information 2016/08/12
Last modified on 2016/08/12

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Basic information
Public title Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study
Acronym Resting-state fMRI study for patients with chronic pain
Scientific Title Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study
Scientific Title:Acronym Resting-state fMRI study for patients with chronic pain
Region
Japan

Condition
Condition Chronic pain patients
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to explore a specific brain network at rest in patients with chronic pain using fMRI.
Basic objectives2 Others
Basic objectives -Others Other pursoses include investigating a relationship between a subjctive pain score and strength of resting-state functional connectivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Altered spontaneous brain activity across affective pain regions
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed as functional pain syndrome, such as fibromyalgia, complex regional pain syndrome, or postherpetic neuralgia. Diagnosis is confirmed by pain clinicians.
Key exclusion criteria Exclusion criteria comprised substance abuse, psychiatric illness, pregnancy et al.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromichi Kurosaki
Organization Wakayama medical university
Division name department of operation center
Zip code
Address 811-1 Kimiidera, Walayama city, Wakayama
TEL 073-441-0611
Email kurosaki@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Kurosaki
Organization Wakayama medical university
Division name department of operation center
Zip code
Address 811-1 Kimiidera, Wakayama city, Wakayama
TEL 073-441-0611
Homepage URL
Email kurosaki@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Institute
Department

Funding Source
Organization Wakayama medical university
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 12 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
2015 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are attempting to recruit patients suffering from postherpetic heuralgia.

Management information
Registered date
2016 Year 08 Month 12 Day
Last modified on
2016 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027176

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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