UMIN-CTR Clinical Trial

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
Email	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
Email	nakamtat@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053811