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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007985
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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