UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047416 |
|---|---|
| Receipt number | R000054076 |
| Scientific Title | VR neurorehabilitation for neuropathic pain |
| Date of disclosure of the study information | 2022/04/07 |
| Last modified on | 2022/04/06 15:14:09 |
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Basic information
Public title
VR neurorehabilitation for neuropathic pain
Acronym
VR neurorehabilitation for neuropathic pain
Scientific Title
VR neurorehabilitation for neuropathic pain
Scientific Title:Acronym
VR neurorehabilitation for neuropathic pain
Region
| Japan |
Condition
Condition
neuropathic pain
Classification by specialty
| Medicine in general | Neurology | Surgery in general |
| Orthopedics | Anesthesiology | Neurosurgery |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
neuropathic pain alleviation by VR treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain intensity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
virtual reality
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) lower limb neuropathic pain with motor paralysis
2) pain duration >_ 3 months
3) pain intensity (NRS) >_ 4
Key exclusion criteria
1) life limiting within 6 months
2) cognitive impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo
Division name
Hospital
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-3815-5411
sumitanim-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo
Division name
Hospital
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-3815-5411
Homepage URL
sumitanim-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
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
The University of Tokyo
Address
Hongo 7-3-1, Bunkyo, Tokyo
Tel
03-3815-5411
sumitanim-ane@h.u-tokyo.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
| 2022 | Year | 04 | Month | 07 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054076
