UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037337 |
|---|---|
| Receipt number | R000042565 |
| Scientific Title | Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2019/07/11 14:50:03 |
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Basic information
Public title
Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain
Acronym
Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain
Scientific Title
Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain
Scientific Title:Acronym
Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain.
We investigate the effects of cue-based expectations for pain in patients with chronic pain on cerebral hemodynamic responses using near-infrared spectroscopy(NIRS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral hemodynamics(Oxy-Hb, Deoxy-Hb, Total-Hb)
Key secondary outcomes
Visual Analog Scale(VAS)
Heart rate
Skin conductance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with chronic pain
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients over 20 years old
patients who regularly go to the pain clinic
Key exclusion criteria
patients with a past history of heart disease
Pregnant female
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Yamazaki |
Organization
University of Toyama
Division name
Department of anesthesiology
Zip code
930-0194
Address
2630, Sugitani, Toyama, Japan
TEL
076-434-7377
myama@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hibi |
Organization
University of Toyama
Division name
Department of anesthesiology
Zip code
930-0194
Address
2630, Sugitani, Toyama, Japan
TEL
076-434-7377
Homepage URL
d1661011@ems.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
2630, Sugitani, Toyama, Japan
Tel
076-434-7681
rinri@adm.u-toyama.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
| 2019 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042565
