UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052917 |
|---|---|
| Receipt number | R000060375 |
| Scientific Title | A prospective open-label, non-contrastive study on the effects and mechanism of VR(virtual reality) on chronic neuropathic pain |
| Date of disclosure of the study information | 2023/11/28 |
| Last modified on | 2023/11/27 16:36:31 |
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Basic information
Public title
A prospective study on the effects and mechanism of VR(virtual reality) on chronic neuropathic pain
Acronym
A clinical study on the effects of VR(virtual reality) on chronic neuropathic pain
Scientific Title
A prospective open-label, non-contrastive study on the effects and mechanism of VR(virtual reality) on chronic neuropathic pain
Scientific Title:Acronym
A prospective study on the effects of VR(virtual reality) on chronic neuropathic pain
Region
| Japan |
Condition
Condition
chronic neuropathic pain
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we apply the treatment using VR (virtual reality) to the patients with chronic neuropathic pain, and evaluate the effects of VR on their pain. We evaluate the pain intensity and the extent of physical disabilities in their daily life, as well as analyze the change of brain blood flow measured by NIRS(near-infrared spectroscopy). We also aim to reveal the mechanism how VR treatment works on alleviating the pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intensity of pain measured by NRS (numerical rating scale)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Research subjects experience an original VR program (a shooting game which takes about 10 minutes) using a VR headset once a day from day 0 to day 28. They visit the outpatient clinic on day 0, 14 and 28, when the intensity of pain and the extent of physical disabilities related to the pain are evaluated. They also experience the VR program with the NIRS device attached to their frontal head, which measures the change of blood flow in the frontal brain.
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
Research subjects should be patients who are treated in the outpatient pain clinic at our hospital, are 20 years old or older, regardless of gender. They also should have chronic neuropathic pain for more than 3 months.
Key exclusion criteria
The patients below should be excluded.
-the patients who cannot agree on joining the research
-the patients who also have nociceptive pain or neuroplastic pain
-the patients who are expected to be difficult to comply with the protocol or evaluate the outcome because of having psychotic illness or cognitive dysfunction
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Hamaoka |
Organization
Juntendo University of Medicine
Division name
The department of anesthesiology and pain clinic
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
s-hamaoka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Hamaoka |
Organization
Juntendo University of Medicine
Division name
The department of anesthesiology and pain clinic
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
s-hamaoka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2023 | Year | 11 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 21 | 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
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060375
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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