UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037712 |
|---|---|
| Receipt number | R000042918 |
| Scientific Title | Analysis on hyperalgesia in chronic pain |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2023/05/23 10:37:44 |
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Basic information
Public title
Analysis on hyperalgesia in chronic pain
Acronym
hyperalgesia in chronic pain
Scientific Title
Analysis on hyperalgesia in chronic pain
Scientific Title:Acronym
hyperalgesia in chronic pain
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Medicine in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore findings specific to chronic pain, especially fibromyalgia.
Basic objectives2
Others
Basic objectives -Others
Using resting state functional MRI.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Specific functional connections are observed depending on the pathology of chronic pain, especially fibromyalgia.
Key secondary outcomes
Symptoms associated with specific functional connectivity are seen.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet the 2016 ACR fibromyalgia diagnostic criteria with or without a low pain threshold and agree to participate in the study. Healthy subjects.
Key exclusion criteria
Subjects were excluded if they had following conditions; a history of neurological or major psychiatric illness, the presence of significant medical disorder, alcohol/drug abuse, left handed, current pregnancy or breastfeeding, less than 20 years old, more than 70 years old, conditions interfering with MRI procedure mentally and physically, abnormal findings on simple brain MRI.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Aoe |
Organization
Teikyo University, Chiba Medical Center
Division name
Pain Center
Zip code
299-0111
Address
3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan
TEL
0436-62-1211
tomohikoA@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Aoe |
Organization
Teikyo University, Chiba Medical Center
Division name
Pain Center
Zip code
299-0111
Address
3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan
TEL
0436-62-1211
Homepage URL
tomohikoA@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University, Chiba Medical Center
Institute
Department
Personal name
Funding Source
Organization
Teikyo University, Chiba Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University, IRB
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-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
帝京大学・ちば総合医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyzing BOLD signal time-series changes in all brain regions (voxels) to determine nerve functional connectivity, and clarifying regions showing significant differences between chronic pain patients and controls.
Management information
Registered date
| 2019 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042918
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
