UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clarification of mechanism of pain perception
Title of the study (Brief title)	Clarification of mechanism of pain perception
Region	Japan

Condition
Condition	Chronic Pain
Classification by specialty	Anesthesiology Neurosurgery Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the mechanism of chronic pain
Basic objectives2	Others
Basic objectives -Others	To clarify the factors that contribute to the mechanism of chronic pain
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in pain score before and after treatment
Key secondary outcomes	1.MRI imaging test results, etc. 2.Cognitive function test score 3.Scores of various psychological tests 4.Results of haematological tests 5.Extent of adverse events

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	16 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with age over 16 years old at the time of obtaining informed consent in 2.Patients with voluntary consent of the patient document after the patient received an adequate explanation and understanding Upon participation in this study
Key exclusion criteria	Patients deemed inappropriate as subjects by principal investigator
Target sample size	1050

Research contact person
Name of lead principal investigator	Aya Nakae
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology & Intensive Care
Address	2-2, Yamadaoka, Suita
TEL
Email

Public contact
Name of contact person
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology & Intensive Care
Address
TEL	06-6879-2649
Homepage URL
Email

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Global Center of Excellence
Organization
Division
Category of Funding Organization
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	2012 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 28 Day
Anticipated trial start date	2012 Year 01 Month 01 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	1.Basic patient information : age, gender, height, weight, medical history, omplications 2.Blood test : white blood cell count, neutrophil count, platelet count, hemoglobin 3.Psychological study : HAD, SF-MPQ, PDAS, PCS, STAI, SF-36.etc 4.Pain sensitivity test: Using Pain Vision PATHWAY, Inc. NIPRO 5.Cognitive function test:RST and LST 6.Imaging tests:MRI

Management information
Registered date	2012 Year 05 Month 18 Day
Last modified on	2018 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009400