UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study
Title of the study (Brief title)	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	Hiromichi Kurosaki
Organization	Wakayama medical university
Division name	department of operation center
Address	811-1 Kimiidera, Walayama city, Wakayama
TEL	073-441-0611
Email	kurosaki@wakayama-med.ac.jp

Public contact
Name of contact person	Hiromichi Kurosaki
Organization	Wakayama medical university
Division name	department of operation center
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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