UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047894 |
|---|---|
| Receipt number | R000054190 |
| Scientific Title | Quantitative evaluation of experimental acute pain using Pain Vision TM |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/05/30 19:57:45 |
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Basic information
Public title
Attempt to quantify acute pain using Pain Vision TM
Acronym
Quantification of pain
Scientific Title
Quantitative evaluation of experimental acute pain using Pain Vision TM
Scientific Title:Acronym
Evaluation of acute pain using Pain Vision TM
Region
| Japan |
Condition
Condition
acute pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although it has been difficult to objectively quantitatively evaluate the magnitude of pain, PainVisionTM has recently shown that pain evaluation (pain degree) by sensory current is useful for quantitative evaluation of chronic pain. Therefore, we will examine whether PainVisionTM is useful for quantitative evaluation of pain in human acute pain models for volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between pain degree using PainVisionTM and visual analogue scale (VAS) or numerical rating scale (NRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Capsaicin: 1% capsaicin 0.1 ml, subcutaneously administered
Interventions/Control_2
Mustard oil: 1 x 1 cm, applied for 5 minutes
Interventions/Control_3
Needle puncture: Disposable needle puncture 5 mm perpendicular to the skin
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.Healthy adults who are 20 years of age or older at the time of consent acquisition
2.Persons who have obtained written consent based on the free will of the subject after receiving sufficient explanation for participation in this study.
Key exclusion criteria
1.Those who have previously been allergic to capsaicin (chili pepper) and mustard oil (mustard) and those who are afraid of needles (aichmophobia)
2.Patients with a history of central nervous system disorder, heart disease, respiratory disease, or renal disease
3.Those who are taking painkillers
4.Pregnant or lactating female patients
5.Persons who the principal investigator deems inappropriate as a subject
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Mikito |
| Middle name | |
| Last name | Kawamata |
Organization
Shinshu university school of medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-37-2670
kawamata@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yoshiyama |
Organization
Shinshu university school of medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-37-2670
Homepage URL
yoshiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university school of medicine, Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Medical Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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 | 06 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054190
