UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054797 |
|---|---|
| Receipt number | R000061905 |
| Scientific Title | Comprehensive Study on Chronic Pain from Psychological, Physical, and Neurological Perspectives |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/06/28 09:18:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comprehensive Study on Chronic Pain from Psychological, Physical, and Neurological Perspectives
Acronym
Comprehensive Study on Chronic Pain
Scientific Title
Comprehensive Study on Chronic Pain from Psychological, Physical, and Neurological Perspectives
Scientific Title:Acronym
Comprehensive Study on Chronic Pain
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Psychiatry | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate the vicious cycle of pain from various perspectives and utilize it in new diagnostic and therapeutic methods in the future.
Basic objectives2
Others
Basic objectives -Others
Presenteeism, or decreased work performance due to health problems despite attendance, is a major source of productivity loss. The effect of pain on presenteeism is not fully understood, as pain is multifaceted and closely linked to psychosocial factors. We conduct this cross-sectional study to clarify the factors involved.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric rating scale (pain intensity)
Key secondary outcomes
Health and Work Performance Questionnaire
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
[Chronic Pain Patients] (1) Age 20 years or older (2) Pain has significantly interfered with daily life within the past 6 months. (3) Meets the diagnostic criteria for chronic pain (experiencing pain on at least 90 days for 3 months in the past 6 months). (4) Pain intensity of 3 or greater on the NRS (0-10) on 45 or more days in the past 3 months. (5) The patient has given informed consent.
(2) Informed consent has been obtained (3) No specific history of physical or psychiatric illness and no regular medication use.
Key exclusion criteria
Failure to meet selection criteria
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Yoshino |
Organization
Hiroshima University
Division name
Health Service Center
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575096
yoshino@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuo |
| Middle name | |
| Last name | Yoshino |
Organization
Hiroshima University
Division name
Health Service Center
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575096
Homepage URL
yoshino@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-5947
iryo-sinsa@office.hiroshima-u.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
| 2024 | Year | 07 | Month | 01 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none in particular
Management information
Registered date
| 2024 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061905
