UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056454 |
|---|---|
| Receipt number | R000064425 |
| Scientific Title | Multimodal biometric measurements using sensory/emotional stimulation for chronic pain |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2024/12/13 17:44:18 |
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Basic information
Public title
Multimodal biometric measurements using sensory/emotional stimulation for chronic pain
Acronym
Multimodal biometric measurements using sensory/emotional stimulation for chronic pain
Scientific Title
Multimodal biometric measurements using sensory/emotional stimulation for chronic pain
Scientific Title:Acronym
Multimodal biometric measurements using sensory/emotional stimulation for chronic pain
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Psychiatry | Orthopedics | Laboratory medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate differences in biological reactivity between chronic pain patients and healthy controls.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Multimodal biometric measurements
- Brain function
- Heart rate variability
- Pupil Size, Blink, Eye-tracking
Key secondary outcomes
Questionnaire
- Pain
- Emotion
- Body image disturbance
- Central sensitization-related symptoms
- Task-related assessments
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Conduct sensory/emotional stimulation for patients with chronic pain.
Interventions/Control_2
Conduct sensory/emotional stimulation for healthy controls.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic pain lasting more than 3 months
Age 18 and over
Key exclusion criteria
1. Individuals with disabilities that make it difficult to perform stimulus tasks
2. Individuals with severe mental disorders (e.g., dementia) that hinder participation
3. Individuals deemed unsuitable for study participation by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ushida |
Organization
Aichi Medical University
Division name
Department of Pain Medicine
Zip code
480-1195
Address
1-1 yazako karimata, Nagakute, Aichi
TEL
0561-62-5004
ushidat@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Nakaso |
Organization
Aichi Medical University
Division name
Department of Pain Medicine
Zip code
480-1195
Address
1-1 yazako karimata, Nagakute, Aichi
TEL
0561-62-5004
Homepage URL
nakaso.y@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical 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
Aichi Medical University
Address
1-1 yazako karimata, Nagakute, Aichi
Tel
0561-62-3311
amu_ethics@aichi-med-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
| 2024 | Year | 12 | Month | 15 | 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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064425
