UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042827 |
|---|---|
| Receipt number | R000046413 |
| Scientific Title | Development of simple and multimodal evaluation of pain sensitization for patients with chronic pain Phase 5: Prevalence of pain sensitization in patients with chronic pain |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2022/12/26 19:11:46 |
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Basic information
Public title
Development of simple and multimodal pain evaluation for patients with chronic pain
Phase 5: Prevalence of pain sensitization in patients with chronic pain
Acronym
Development of simple and multimodal pain evaluation for patients with chronic pain
Phase 5: Prevalence of pain sensitization in patients with chronic pain
Scientific Title
Development of simple and multimodal evaluation of pain sensitization for patients with chronic pain
Phase 5: Prevalence of pain sensitization in patients with chronic pain
Scientific Title:Acronym
Development of simple and multimodal evaluation of pain sensitization for patients with chronic pain
Phase 5: Prevalence of pain sensitization in patients with chronic pain
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Medicine in general | Neurology | Clinical immunology |
| Psychosomatic Internal Medicine | Geriatrics | Psychiatry |
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prevalence and severity of pain sensitization in patients with chronic pain
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence and severity of pain sensitization
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who has been suffering from pain more than 3 months, with the severity of worst pain in the past week >40 in 100mm visual analogue scale (VAS)
2. Patients who has been suffering from persistent pain after surgery more than 6 months, with the severity of worst pain in the past week >40 in 100mm VAS
Key exclusion criteria
1. Acute inflammatory condition (ex. trauma, infection)
2. Skin disorders around pain assessment area
3. Psychological disorders (ex. dementia)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Izumi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopedic surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi Pref.
TEL
088-880-2386
izumim@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Morita |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopedic surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi Pref.
TEL
088-880-2386
Homepage URL
im35@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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 Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi Pref.
Tel
088-880-2180
is21@kochi-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
| 2020 | Year | 12 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046413
