UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007985
Receipt number R000009400
Scientific Title Clarification of mechanism of pain perception
Date of disclosure of the study information 2012/05/18
Last modified on 2018/11/21 12:27:02

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Basic information

Public title

Clarification of mechanism of pain perception

Acronym

Clarification of mechanism of pain perception

Scientific Title

Clarification of mechanism of pain perception

Scientific Title:Acronym

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

1st name
Middle name
Last name Aya Nakae

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesiology & Intensive Care

Zip code


Address

2-2, Yamadaoka, Suita

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesiology & Intensive Care

Zip code


Address


TEL

06-6879-2649

Homepage URL


Email



Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



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)



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

2012 Year 05 Month 18 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

2011 Year 12 Month 28 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name