UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052352 |
|---|---|
| Receipt number | R000059749 |
| Scientific Title | Evaluation of a smartphone application that analyzes sensory changes and autonomic responses in chronic pain sufferers induced by short term lowering barometric pressure |
| Date of disclosure of the study information | 2023/10/05 |
| Last modified on | 2024/03/30 11:35:42 |
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Basic information
Public title
Evaluation of a smartphone application that analyzes sensory changes and autonomic responses in chronic pain sufferers induced by short term lowering barometric pressure
Acronym
Evaluation of a smartphone application that analyzes the onset of weather-related pain and autonomic imbalance
Scientific Title
Evaluation of a smartphone application that analyzes sensory changes and autonomic responses in chronic pain sufferers induced by short term lowering barometric pressure
Scientific Title:Acronym
Evaluation of a smartphone application that analyzes the onset of weather-related pain and autonomic imbalance
Region
| Japan |
Condition
Condition
weather-related pain
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a performance evaluation of a "Pain Application" that objectively presents the characteristics of pain, which worsens due to bad weather, in combination with changes in autonomic activity. In other words, this smartphone application accurately detects changes in pain and changes in autonomic activity induced by a low-pressure environment that simulates bad weather, and confirms that when pain intensifies, stress levels simultaneously increase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in pain score (Numeric Rating Scale) induced by low-pressure exposure
Key secondary outcomes
1) Pulse and pulse wave interval fluctuations
2) Artificial weather data (barometric pressure, temperature, humidity)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects are exposed to a low-pressure environment (atmospheric pressure -40hPa; 30min.) that simulates weather disturbances. A smartphone application will then accurately detect changes in pain and changes in autonomic activity induced by lowering barometric pressure, and confirm that when pain intensifies, stress levels simultaneously increase.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All of the following selection criteria must be met.
1) Patients visiting the Pain Center (20-49 years old) who have consented to participate in the study.
2) A person who answered the Weather-Related Pain Checklist and Seven Questions About Weather Dependency to determine if they have a moderate headache as defined and, are affected by bad weather. Those for whom it was confirmed that the pain worsened.
3) Those who are able to participate in one low-pressure exposure experiment according to the schedule specified by the researcher.
Key exclusion criteria
Persons who violate any of the following will not be included in this survey.
1) Aichi Medical University student
2) Those who are pregnant or breastfeeding
3) Persons suffering from diseases that must be excluded from research subjects. Diseases not targeted for this research are defined as a secondary headache that does not meet the diagnostic criteria for primary headaches (migraine, tension-type headache, or both) and is caused by another disease or condition.
4) Others (under medication, treatment, etc.) who are deemed unsuitable as participants by the principal investigator and co-investigators.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ushida |
Organization
Aichi Medical University
Division name
Department of Pain Medicine
Zip code
480-1195
Address
1-1 Yazako-Karimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
ushidat@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Sakurai |
Organization
Aichi Medical University
Division name
Department of Pain Medicine
Zip code
480-1195
Address
1-1 Yazako-Karimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
hsaku@hm.tokoha-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Takahiro Ushida
Funding Source
Organization
Pascal Universe Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Yazako-Karimata, Nagakute, Aichi , Japan
Tel
0561-62-3311
mori.yuuki.375@mail.aichi-med-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
| 2023 | Year | 10 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059749
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| Registered date | File name |
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