UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024802
Receipt No. 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 (Ver. 4)

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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
Email 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
Email morim2@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028537