UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052834 |
|---|---|
| Receipt number | R000060038 |
| Scientific Title | Electrical pain thresholds about the upper and lower limbs of headache patients |
| Date of disclosure of the study information | 2023/11/30 |
| Last modified on | 2023/11/18 00:38:44 |
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Basic information
Public title
Electrical pain thresholds about the upper and lower limbs of headache patients
Acronym
Electrical pain thresholds about the upper and lower limbs of headache patients
Scientific Title
Electrical pain thresholds about the upper and lower limbs of headache patients
Scientific Title:Acronym
Electrical pain thresholds about the upper and lower limbs of headache patients
Region
| Japan |
Condition
Condition
Migraine Headache, Drug Abuse Headache, Headache Due to Low CSF Pressure
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to advance the treatment and pathophysiological understanding of chronic headaches through a detailed assessment of pain thresholds in affected patients. By conducting this evaluation, we intend to uncover critical insights that could inform more effective and targeted therapeutic interventions.
Basic objectives2
Others
Basic objectives -Others
This study aims to advance the treatment and pathophysiological understanding of chronic headaches through a detailed assessment of pain thresholds in affected patients. By conducting this evaluation, we intend to uncover critical insights that could inform more effective and targeted therapeutic interventions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we will assess the pain thresholds in the bilateral medial forearm and Achilles tendon regions using NIPRO's Pain Vision, a Perception and Pain Quantitative Analyzer. This measurement aims to delineate the distinct characteristics and disparities among various disease groups.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients visiting the outpatient clinic for migraines, medication-overuse headaches, or headaches due to low cerebrospinal fluid (CSF) pressure will be selected for inclusion. Inclusion criteria are based on the diagnostic guidelines from the International Classification of Headache Disorders, 3rd Edition (ICHD-3). Furthermore, a control group consisting of age- and sex-matched healthy individuals over 20 years old without any underlying medical conditions will also be incorporated.
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Saitama Medical University Hospital
Division name
department of neurology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan
TEL
0492761111
kawasaki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Saitama Medical University Hospital
Division name
department of neurology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan
TEL
0492761111
Homepage URL
kawasaki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
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
Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan
Tel
0492761111
kawasaki@saitama-med.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 | 11 | Month | 30 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will include an evaluation of various parameters to determine their correlation with pain thresholds. These parameters encompass the timing of the last headache attack, the presence or absence of headache at the time of threshold measurement, the use and timing of analgesics or other medications, assessments using the Numerical Rating Scale, Migraine Interictal Burden Scale (MIBS-4), Central Sensitization Inventory (CSI) Japanese version, Beck Depression Scale, Headache Impact Test-6 (HIT-6) Japanese version, and the Migraine Disability Assessment (MIDAS).
Management information
Registered date
| 2023 | Year | 11 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060038
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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