UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023604 |
|---|---|
| Receipt number | R000027176 |
| Scientific Title | Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study |
| Date of disclosure of the study information | 2016/08/12 |
| Last modified on | 2016/08/12 14:59:06 |
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Basic information
Public title
Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study
Acronym
Resting-state fMRI study for patients with chronic pain
Scientific Title
Plasticity of spontaneous brain fluctuation in patients with functional chronic pain: a resting-state fMRI study
Scientific Title:Acronym
Resting-state fMRI study for patients with chronic pain
Region
| Japan |
Condition
Condition
Chronic pain patients
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore a specific brain network at rest in patients with chronic pain using fMRI.
Basic objectives2
Others
Basic objectives -Others
Other pursoses include investigating a relationship between a subjctive pain score and strength of resting-state functional connectivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Altered spontaneous brain activity across affective pain regions
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as functional pain syndrome, such as fibromyalgia, complex regional pain syndrome, or postherpetic neuralgia. Diagnosis is confirmed by pain clinicians.
Key exclusion criteria
Exclusion criteria comprised substance abuse, psychiatric illness, pregnancy et al.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kurosaki |
Organization
Wakayama medical university
Division name
department of operation center
Zip code
Address
811-1 Kimiidera, Walayama city, Wakayama
TEL
073-441-0611
kurosaki@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kurosaki |
Organization
Wakayama medical university
Division name
department of operation center
Zip code
Address
811-1 Kimiidera, Wakayama city, Wakayama
TEL
073-441-0611
Homepage URL
kurosaki@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
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
Address
Tel
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
| 2016 | Year | 08 | Month | 12 | 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
| 2015 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are attempting to recruit patients suffering from postherpetic heuralgia.
Management information
Registered date
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027176
