UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024802 |
|---|---|
| Receipt number | R000028537 |
| Scientific Title | Study of weather changes on chronic pain |
| Date of disclosure of the study information | 2016/11/11 |
| Last modified on | 2020/11/14 17:14:22 |
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Basic information
Public title
Study of weather changes on chronic pain
Acronym
Weather changes on chronic pain
Scientific Title
Study of weather changes on chronic pain
Scientific Title:Acronym
Weather changes on chronic pain
Region
| Japan |
Condition
Condition
Patients with chronic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In chronic pain patients, whether the degree of pain is associated with any parameter of the weather is measured using a Visual Analogue Scale (VAS).In addition, there are differences depending on the season or, in between the group is not the case with the group to meet the diagnostic criteria due to suitai score or kiutsu score, investigate whether there is a difference in the degree of pain.
Basic objectives2
Others
Basic objectives -Others
Impact of weather to chronic pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between strength and change in pain from the previous day and the changes from the previous day of the weather, temperature, and atmospheric pressure
Key secondary outcomes
1 Comparing the summer and winter
2 The difference of pain intensity and change between between the groups that meet the diagnostic criteria of suitai or kiutsu
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 living in Sapporo who undergo treatment more than one year for pain clinic at Hokkaido university hospital anesthesiology ambulatory
Key exclusion criteria
Patients principal investigator has determined to be inappropriate as a research subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
0608648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
0608648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
morim2@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
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
Hokkaido University Hospital
Address
N14 W5, Kita-ku, Sapporo
Tel
011-716-1161
morim2@med.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
31
Results
The highest values of VAS during the observation period were significantly correlated with low air pressure on the day of visit, low humidity on the day before visit, and increased humidity on the day of visit.
There was no difference in pain between summer and winter.
Results date posted
| 2020 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult chronic pain patients who live in the city
Participant flow
none
Adverse events
none
Outcome measures
Primary outcome: Parameters most strongly associated with pain severity
Secondary outcome: differences in pain by season
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Study period: until 2017.7.25
Adult patients who live in Sapporo and undergo treatment for pain clinic more than one year at Hokkaido University Hospital anesthesiology ambulatory
Observational items:VAS at the time of examination and at the same time the day before examination, gender, age, height, weight, disease, other medical history, complications, pre-existing conditions, suitai score, kiutsu score, weather, temperature, barometric pressure, humidity in Sapporo
Management information
Registered date
| 2016 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028537
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
