UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029339 |
|---|---|
| Receipt number | 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 | 2022/10/02 09:13:10 |
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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 | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3812
masa@keio.jp
Public contact
Name of contact person
| 1st name | Osahiko |
| Middle name | |
| Last name | Tsuji |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3812
Homepage URL
osahiko@2003.jukuin.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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: 12ml blood sampling of these patients with neuropathic pain at 3 time-points (pre-operative, 2 weeks and 3 months after surgery)
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033532
