UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018099 |
|---|---|
| Receipt number | R000020925 |
| Scientific Title | Survey for Quality of Working Life Influenced by Chronic Pain (QWLIC survey) |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2020/12/29 15:43:53 |
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Basic information
Public title
Survey for Quality of Working Life Influenced by Chronic Pain (QWLIC survey)
Acronym
QWLIC survey
Scientific Title
Survey for Quality of Working Life Influenced by Chronic Pain (QWLIC survey)
Scientific Title:Acronym
QWLIC survey
Region
| Japan |
Condition
Condition
Chronic Pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of chronic pain and characteristics of patients in industry
Basic objectives2
Others
Basic objectives -Others
Nothing due to observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of chronic pain
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
paid staff in a cooperative firm
Key exclusion criteria
persons taking a leave
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shizuko |
| Middle name | |
| Last name | Kosugi |
Organization
Keio University of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35, Shinanomachi, Shinjukuku, Tokyo
TEL
03-5363-3810
shizuko.kosugi@gmail.com
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Wakaizumi |
Organization
Keio University of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35, Shinanomachi, Shinjukuku, Tokyo
TEL
03-5363-3810
Homepage URL
k.wakamail@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio Program for Leading graduate school, Science for Improvement of Super Mature Society
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
Keio University School of Medicine
Address
35, Shinanomachi, Shinjukuku, Tokyo
Tel
03-3353-3611
med-rinri-jimu@adst.kelo.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
| 2015 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
http://keio-anesthesiology.jp/department/study/clinical/pdf/20160402.pdf
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-016-2303-1
Number of participants that the trial has enrolled
433
Results
We found a significant association between high TSK scores and CP in Japanese white collar workers when controlling for other known factors that influence CP such as work related psychosocial characteristics and depressive conditions.
Results date posted
| 2020 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age, sex, weight, height, smoking habit, daily alcohol intake, highest education achieved, exercise routine, daily working hours, and sleep duration.
Participant flow
Participants responded questionnaire distributed.
Adverse events
None
Outcome measures
Experience of pain, participant sociodemographic/health/lifestyle characteristics, fear-avoidance beliefs [Tampa Scale for Kinesiophobia (TSK)], work-related psychosocial factors (Brief Job Stress Questionnaire), and depressive illness [Psychological Distress Scale (K6)].
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Age, Sex, Sleep, Depression, Stress, and Fear avoidance thinking are investigated for the relationship to chronic pain in a company.
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020925
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/12/27 | 倫理審査結果通知書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/12/13 | 産業界痛みアンケート入力フォーム規則.pdf |
