UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047175 |
|---|---|
| Receipt number | R000053811 |
| Scientific Title | Analysis of Emotional Factors and Related Molecules Influencing Prognosis in Patients with Intractable chronic Pain using neuro liquid biopsy |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2022/03/15 11:22:55 |
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Basic information
Public title
Analysis of Emotional Factors and Related Molecules Influencing Prognosis in Patients with Intractable chronic Pain using neuro liquid biopsy
Acronym
Analysis of emotional factor and exosomes in chronic pain
Scientific Title
Analysis of Emotional Factors and Related Molecules Influencing Prognosis in Patients with Intractable chronic Pain using neuro liquid biopsy
Scientific Title:Acronym
Analysis of emotional factor and exosomes in chronic pain
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Psychosomatic Internal Medicine | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Translational research will be conducted on chronic pain patients, focusing on the influence of emotional factors such as thinking and cognition on the pathophysiology of chronic pain. The research will 1) search for emotion-related factors that modulate prognosis and quality of life in chronic pain patients using brain liquid biopsy, and 2) clarify the effects of these molecules on plastic changes in the central nervous system in a pathology-dependent manner. The identified molecules will not only serve as prognostic and diagnostic markers for chronic pain, but also as potential target molecules for chronic pain drugs with novel molecular mechanisms.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of miRNA expression in neuro-derived exosomes with the rate of change in the catastrophic thinking scale before and after treatment of chronic pain patients across groups.
Key secondary outcomes
1) Comparison of miRNA expression in nerve-derived exosomes between a group of healthy subjects without chronic pain and a group of patients with chronic pain
2) Examination of the relationship between clinical assessment measures and exosomal proteins and miRNAs based on omics analysis and pre- and post-treatment correlations of the following items
For the clinical evaluation scale, the following items will be calculated from the questionnaire in addition to the basic patient information
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic pain that has persisted for at least 3 months since onset (regardless of previous treatment)
Patients with a numerical rating scale (NRS) of 6 or higher on a scale of 0 to 10, in addition to the evaluation with the Chronic Pain Acceptance Questionnaire (CPAQ), while already receiving medication as indicated in the Guidelines for the Treatment of Neuropathic Pain.
Key exclusion criteria
Those who have difficulty completing the questionnaire
Those who have difficulty in continuing treatment for 8 weeks
Other persons deemed inappropriate as research subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Nakamoto |
Organization
Kansai Medical University Hospital
Division name
Pain center
Zip code
573-1191
Address
2-3-1 Sinmachi, Hirakata, Osaka
TEL
072-804-0101
nakamtat@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Nakamoto |
Organization
Kansai Medical University Hospital
Division name
Pain center
Zip code
573-1191
Address
2-3-1 Sinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
nakamtat@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai 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
Kansai medical university IRB
Address
2-3-1 Sinmachi, Hirakata, Osaka
Tel
072-804-2440
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021274
Org. issuing International ID_1
Kansai Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medication, exercise, psychosomatic therapy, and nerve blocks at the pain center for 8 weeks as needed.
Management information
Registered date
| 2022 | Year | 03 | Month | 15 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053811
