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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022027
Receipt No. R000025385
Scientific Title Predictive factors of treatment response for chronic lower back pain patients
Date of disclosure of the study information 2016/04/25
Last modified on 2019/04/26

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Basic information
Public title Predictive factors of treatment response for chronic lower back pain patients
Acronym Predictive factors of treatment response for chronic lower back pain patients
Scientific Title Predictive factors of treatment response for chronic lower back pain patients
Scientific Title:Acronym Predictive factors of treatment response for chronic lower back pain patients
Region
Japan

Condition
Condition Chronic lower back pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study predictive factors of treatment response for chronic lower back pain patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between pain score and questionnaires
Key secondary outcomes Relationship among questionnaires

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have lower back pain over three months.
Key exclusion criteria Patients who could not answer questionnaires
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Osamu
Organization Fujita Health University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2000
Email nishida@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Junpei
Middle name
Last name Shibata
Organization Fujita Health University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2925
Homepage URL
Email shibata@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine Department of Anesthesiology and Critical Care Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine Department of Anesthesiology and Critical Care Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Review Committee of Fujita Health University
Address 1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi, Japan
Tel 0562-93-2865
Email firb@fujita-hu.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 藤田医科大学病院(愛知)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 16 Day
Date of IRB
2016 Year 03 Month 15 Day
Anticipated trial start date
2016 Year 03 Month 16 Day
Last follow-up date
2021 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study of relationship between pain scores and questionnaires for chronic lower back pain patients.

Management information
Registered date
2016 Year 04 Month 22 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025385

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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