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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032652
Receipt No. 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

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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
Email 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
Email ytomi@yokohama-cu.ac.jp

Sponsor
Institute Department of anesthsiology, medical faculty
Yokohama city university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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