UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of a multidisciplinary and comprehensive strategy for chronic pain
Title of the study (Brief title)	Comprehensive strategy for chronic pain
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this research is that the combination of the subjective (questionnaire) and objective (MRI) assessment method for chronic pain.
Basic objectives2	Others
Basic objectives -Others	The development of multidisciplinary and comprehensive strategy for chronic pain
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	MRI
Key secondary outcomes	questionnaire

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Chronic pain patients
Key exclusion criteria	Pregnant
Target sample size	50

Research contact person
Name of lead principal investigator	Yuichi Ogino
Organization	Gunma University
Division name	Anesthesiology
Address	3-39-22 Showamachi, Maebashi 371-8511, Japan
TEL	027-220-7111
Email	yogino@gunma-u.ac.jp

Public contact
Name of contact person	Yuichi Ogino
Organization	Gunma University
Division name	IRB
Address	3-39-22 Showamachi, Maebashi 371-8511, Japan
TEL	027-220-7111
Homepage URL
Email	yogino@gunma-u.ac.jp

Sponsor
Institute	Gunma Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2013 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 27 Day
Anticipated trial start date	2013 Year 05 Month 02 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Observational study

Management information
Registered date	2013 Year 04 Month 18 Day
Last modified on	2016 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012321