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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029339
Receipt No. R000033532
Scientific Title Quantitative analysis of neuropathic pain after the surgery of spinal intramedullary tumors.
Date of disclosure of the study information 2017/09/28
Last modified on 2017/09/28

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Basic information
Public title Quantitative analysis of neuropathic pain after the surgery of spinal intramedullary tumors.
Acronym Quantitative analysis of post-operative pain of intramedullary tumors.
Scientific Title Quantitative analysis of neuropathic pain after the surgery of spinal intramedullary tumors.
Scientific Title:Acronym Quantitative analysis of post-operative pain of intramedullary tumors.
Region
Japan

Condition
Condition Intramedullary tumors and lesions.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate and elucidate of the pathological mechanisms of neuropathic pain after intramedullary tumor surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the results of questionnaire concerning neuropathic pain and imaging data by functional MRI.
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who underwent surgery for intramedullary tumors at Keio Univ. Hospital since 2000. Among them, who agree with this study were included.
Key exclusion criteria Exclusion criteria are as follows; who do not agree the purpose of this study, who could not take functional MRI, who were suffered from postoperative complicaions.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Nakamura
Organization Keio University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-5363-3812
Email masa@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osahiko Tsuji
Organization Keio University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-5363-3812
Homepage URL
Email osahiko@2003.jukuin.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Wealfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 09 Month 28 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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1)Questionnaire: pain detect, NPSI ,SF-36
2)Neurological assessment: JOA-sore, Nurick score
3)Qunantitative analysis of neuropathic pain by using pathway (MEDOC), NPS-7000 (Nihon Kohden)
4)functional MRI
5)Screening of biomarker of neuropathic pain specific: 5ml blood sampling of these patients with neuropathic pain

Management information
Registered date
2017 Year 09 Month 28 Day
Last modified on
2017 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033532

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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