UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052517 |
|---|---|
| Receipt number | R000059931 |
| Scientific Title | Effects of brain atrophy and white matter lesions in chronic pain patients |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2023/10/17 16:55:38 |
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Basic information
Public title
Effects of brain atrophy and white matter lesions in chronic pain patients
Acronym
Effects of brain atrophy and white matter lesions in chronic pain patients
Scientific Title
Effects of brain atrophy and white matter lesions in chronic pain patients
Scientific Title:Acronym
Effects of brain atrophy and white matter lesions in chronic pain patients
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the presence and extent of brain atrophy and cerebral small vessel lesions on head MRI in patients with chronic pain.
Basic objectives2
Others
Basic objectives -Others
Using voxel-based morphometry (VBM) as a method to evaluate brain atrophy, we explore the correlation between the location and degree of brain atrophy and various clinical indicators related to chronic pain.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Location and degree of brain atrophy
Key secondary outcomes
Degree of cerebral small vessel disease
Degree of cognitive decline
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 (with pain lasting more than 3 months)
Key exclusion criteria
Patients under 20 years old
Patients with occupying lesions in the brain
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kitahara |
Organization
Yokohama City University Medical Center
Division name
Pain Clinic Internal Medicine
Zip code
232-0024
Address
4-57, Urafunecho, Yokohama Shi Minami Ku, Kanagawa Ken, Japan
TEL
045-261-5656
masakita.ycu.pain@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Tsuchiya |
Organization
Yokohama City University Medical Center
Division name
Anesthesiology
Zip code
236-0004
Address
3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan
TEL
045-787-2800
Homepage URL
yiu41707@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan
Tel
045-787-2800
rinri@yokohama-cu.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
| 2023 | Year | 10 | Month | 20 | 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
58
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
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Basic patient information: age, gender, diagnosis, height, weight, medical history, complications
2) The following indicators regarding chronic pain will be measured at the time of the first visit and every 3 months thereafter. Brief pain inventory (BPI) is used to evaluate pain intensity, Pain Disability Assessment Scale (PDAS) is used to evaluate pain and activity, and Hospital Anxiety and Depression is used to evaluate psychological stress. Scale: HADS (Japanese version), Pain Catastrophizing Scale (PCS Japanese version) as an evaluation of the impact of pain, Pain Self-Efficacy Questionnaire: PSEQ, EuroQol as an indicator of health-related QOL -5D (EQ-5D) Japanese version, Athens Insomnia Scale for insomnia evaluation, Zarit Nursing Care Burden Scale for influence on family, medical insurance score, Locomo25 for motor function evaluation.
3) Clinical information obtained from brain MRI
4) Information obtained by analyzing brain MRI using VBM
5) Cognitive function tests such as Mini-Mental State Examination (MMSE), WMS-R Wechsler Memory Test, Raven Color Matrix Test, and Stroop Test
6) Adverse events
7) Prognosis
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059931
| Research Plan | |
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