UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054668 |
|---|---|
| Receipt number | R000062470 |
| Scientific Title | Investigation on the evaluation of dysfunction of central nervous system in patient with chronic pain using temperature quantitative sensory testing. |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2025/04/09 17:45:32 |
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Basic information
Public title
Investigation on the evaluation of dysfunction of central nervous system in patient with chronic pain using temperature quantitative sensory testing.
Acronym
Investigation on the evaluation of dysfunction of central nervous system in patient with chronic pain using temperature quantitative sensory testing.
Scientific Title
Investigation on the evaluation of dysfunction of central nervous system in patient with chronic pain using temperature quantitative sensory testing.
Scientific Title:Acronym
Evaluation on dysfunction of central nervous system using temperature QST
Region
| Japan |
Condition
Condition
nociplastic pain/neuropathic pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the usefulness of temperature quantitative sensory testing and electroencephalography in the evaluation of dysfunction of cetral nervous system in patient with chronic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between each pain-related score and temperature perception threshold by quantitative sensory testin
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
quantitative sensory testing/electroencephalography
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
Patients attending Aichi Medical University Hospital and Aichi Medical University Medical Center
Patients who have been diagnosed with nociplastic pain or neuropathic pain and have been in pain for more than 3 months
Patients who understand the content of this study and give consent.
Key exclusion criteria
Persons with poorly controlled mental illness
Persons with suspected dementia
Those with peripheral neuropathy due to metabolic or inflammatory diseases
Those with pacemaker implants
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Terajima |
| Middle name | |
| Last name | Yuki |
Organization
Aichi Medical Universtiy
Division name
Department of Pain Medicine
Zip code
4801195
Address
1-1 Yazako-Karimata, Nagakute, Aichi, Japan
TEL
0561625004
terajima.yuuki.289@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Terajima |
| Middle name | |
| Last name | Yuki |
Organization
Aichi Medical University
Division name
Department of Pain Medicine
Zip code
4801195
Address
1-1 Yazako-Karimata, Nagakute, Aichi, Japan
TEL
0561625004
Homepage URL
terajima.yuuki.289@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
INTERCROSS CORPORATION
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
Ethics Committee, Aichi Medical University School of Medicine
Address
1-1 Yazako-Karimata, Nagakute, Aichi, Japan
Tel
0561623311
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 | 06 | Month | 14 | 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 | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062470
