UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032652 |
|---|---|
| Receipt number | R000036684 |
| Scientific Title | Investigation of improvement degree of catastrophic cognition by surgical treatment for chronic low back pain |
| Date of disclosure of the study information | 2018/05/22 |
| Last modified on | 2018/05/20 18:12:22 |
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Basic information
Public title
Investigation of improvement degree of catastrophic cognition by surgical treatment for chronic low back pain
Acronym
Investigation of improvement degree of catastrophic cognition by surgical treatment for chronic low back pain
Scientific Title
Investigation of improvement degree of catastrophic cognition by surgical treatment for chronic low back pain
Scientific Title:Acronym
Investigation of improvement degree of catastrophic cognition by surgical treatment for chronic low back pain
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
verification whether chronic low back pain treatment by surgical therapy contributes to improvement of catastrophic thinking
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain catastrophizing scale one month, three months and sixth months after surgery compared to before surgery
Key secondary outcomes
Search for background factors that affect PCS after surgery.Factors are age, sex, number of family menmbers, education background, marital status, vocational situation, annual income, NRS, PCS, PSEQ, HADS, AIS, EQ5D, locomo 25
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo a surgical treatment for chronic low back pain
Key exclusion criteria
under age of18
reoperation
Target sample size
97
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Tominaga |
Organization
Yokohama city university medical center
Division name
Department of anesthsiology
Zip code
Address
4-57 Urahune Minami-ku, Yokohama, Kanagawa
TEL
045-261-5656
ytomi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Tominaga |
Organization
Yokohama brain and spine center
Division name
Department of Anesthesiology
Zip code
Address
1-2-1 Takigashira Isogo-ku, Yokohama, Kanagawa
TEL
045-753-2500
Homepage URL
ytomi@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of anesthsiology, medical faculty
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology
Yokohama city university medical center
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
Address
Tel
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
横浜市立脳卒中神経脊椎センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
observational research
Management information
Registered date
| 2018 | Year | 05 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036684
| 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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