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
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
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
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
