UMIN-CTR Clinical Trial

Public title

A Study on the Objective Classification of Pain Types Using miRNA Measurement from Blood Tests

Acronym

Pain miRNA Research

Scientific Title

nvestigation of the Association Between Circulating miRNA Profiles and QOL Indicators in Different Pain Classifications

Scientific Title:Acronym

Pain miRNA Research

Region

Japan

Condition

chronic pain

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

This study aims to establish an objective classification method for pain by elucidating the characteristics of circulating miRNA profiles in nociceptive pain, nociplastic pain, and neuropathic pain groups and analyzing their associations with QOL indicators.

Basic objectives2

Others

Basic objectives -Others

Classifying Pain Mechanisms

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Classification of pain using circulating miRNAs (nociceptive pain, nociplastic pain, and neuropathic pain

Key secondary outcomes

Variations in miRNA Expression Levels and Their Association with QOL Indicators (EQ-5D, NRS, PCS, PDAS, TSK-11)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Nociceptive Pain Group 1 (HO Group)
Individuals scheduled to undergo total hip arthroplasty (THA) due to hip osteoarthritis.
Individuals who understand the purpose and details of this study and provide written informed consent voluntarily.
Nociceptive Pain Group 2 (FF Group)
Patients undergoing surgery for femoral fracture.
Individuals who understand the purpose and details of this study and provide written informed consent voluntarily.
Nociplastic Pain Group (CPP Group)
Patients with chronic primary pain (pain with no identifiable physical cause).
Individuals who understand the purpose and details of this study and provide written informed consent voluntarily.
Neuropathic Pain Group (RT/Shingles Group)
Patients undergoing radiotherapy for cancer-related neuropathic pain or patients with postherpetic neuralgia
Individuals who understand the purpose and details of this study and provide written informed consent voluntarily.
Control Group
Individuals without persistent bodily pain for more than three months.
Individuals who understand the purpose and details of this study and provide written informed consent voluntarily.

Key exclusion criteria

(HO Group)
Individuals with severe pain in areas other than the hip joint (bilateral hip osteoarthritis is not excluded).
Individuals with severe cognitive impairment (delirium, dementia, intellectual disability, or other mental function decline) at the time of pre-intervention assessment.
Individuals with significant difficulty in communication, reading, or writing in Japanese.
Individuals deemed unsuitable for participation by the principal investigator.

(FF Group)
Individuals with severe pre-existing hip osteoarthritis.
Individuals with severe cognitive impairment (delirium, dementia, intellectual disability, or other mental function decline) at the time of pre-intervention assessment.
Individuals with significant difficulty in communication, reading, or writing in Japanese.
Individuals deemed unsuitable for participation by the principal investigator.

(CPP Group)
Individuals with conditions requiring urgent medical treatment.
Individuals with a history or current diagnosis of alcohol or drug abuse.
Individuals with a history or current diagnosis of mania or psychosis.
Individuals with significant suicidal ideation.
Individuals with severe cognitive impairment.
Individuals with significant difficulty in communication, reading, or writing in Japanese.
Individuals deemed unsuitable for participation by the principal investigator.

(RT Group)
Individuals experiencing severe pain unrelated to cancer or postherpetic neuralgia.
Individuals with severe cognitive impairment (delirium, dementia, intellectual disability, or other mental function decline) at the time of pre-intervention assessment.
Individuals with significant difficulty in communication, reading, or writing in Japanese.
Individuals deemed unsuitable for participation by the principal investigator.

Control Group
Identical to the CPP group, with the seventh criterion being the inclusion of individuals exhibiting any deviation in the QOL questionnaire.

Target sample size

125

Name of lead principal investigator

1st name	hiroyuki
Middle name
Last name	nishie

Organization

kawasaki Medical School

Division name

Department of Advanced Oncology

Zip code

701-0192

Address

577 matsushima kurashiki

TEL

+81-86-462-1111

Email

nishiehiroyuki@med.kawasaki-m.ac.jp

Name of contact person

1st name	hiroyuki
Middle name
Last name	nishie

Organization

kawasaki Medical School

Division name

Department of Advanced Oncoloby

Zip code

701-0192

Address

577 matsushima kurashiki Japan

TEL

+81-86-462-1111

Homepage URL

Email

nishiehiroyuki@med.kawasaki-ma.ac.jp

Institute

Kawasaki Medical School

Institute

Department

Personal name

hiroyuki nishie

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kawasaki Medical School IRB

Address

577 matsushima Kurashiki Japan

Tel

+81-86-462-1111

Email

kmsrec@med.kawasaki-m.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

03

Month

16

Day

Date of IRB

2026

Year

08

Month

19

Day

Anticipated trial start date

2025

Year

08

Month

19

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Collected Data
Blood Samples (for miRNA analysis)
Case Report Forms
Blood Sampling Schedule
HO/FF Groups (Nociceptive Pain Groups): Blood samples will be collected before and after surgery (preoperatively and 6 months postoperatively).
CPP Group (Nociplastic Pain Group): Blood samples will be collected before and after CBT (prior to treatment initiation and 6 months after treatment).
RT Group (Neuropathic Pain Group): Blood samples will be collected before and after radiotherapy (prior to treatment initiation and 3 months after treatment).
Control Group: Blood samples will be collected once.
QOL Assessment
The following five indicators will be used for quality of life (QOL) evaluation:
EQ-5D Health-related QOL
NRS (Numeric Rating Scale)Pain intensity
PCS (Pain Catastrophizing Scale)Catastrophic thinking
PDAS (Pain Disability Assessment Scale)Functional disability
TSK-11 (Tampa Scale for Kinesiophobia-11) Fear of movement

Registered date

2025

Year

03

Month

16

Day

Last modified on

2025

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065500