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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023628
Receipt No. R000027211
Scientific Title Pain treatment using the Epimed Spring Guide Epidural Catheter
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/15

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Basic information
Public title Pain treatment using the Epimed Spring Guide Epidural Catheter
Acronym Epidural block
Scientific Title Pain treatment using the Epimed Spring Guide Epidural Catheter
Scientific Title:Acronym Epidural block
Region
Japan

Condition
Condition Spondylosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pain relief which derives from spondylosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain assessment in 1,3,6 and 12 month
later after treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Epidural block using the Epimed Spring
Epidural Catheter
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Chronic low back pain of 3-6 months
duration and failed conservative
treatment options
Spinal stenosis
Disc herniation
Osteophyte
Intervertebral foramen stenosis
Spondylotic radiculopaty
Discogenic pain
Failed back surgery syndrome


Key exclusion criteria Spinal instability
Spinal cord syrinx
Infection
Drug addiction
Uncontrolled major depression or
psychiatric disorders
Arachnoiditis
Arterio-venous malfomation
History of adverse reaction to local
anesthetic, steroids,contrast or other
injected medications
Uncontrolled or acute medical illness
Use of antiplatelet medications or
anticoagulants
Pregnant or lactating woman
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadahei Denda
Organization Niigata City General Hospital
Division name Pain Clinic Surgery
Zip code
Address 463-7 Shumoku-cho, Chuo-ku, Niigata, Niigata, 950-1197, Japan
TEL 025-281-5151
Email s-denda@hosp.niigata.niigata.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sadahei Denda
Organization Niigata City General Hospital
Division name Pain Clinic Surgery
Zip code
Address 463-7 Shumoku-cho, Chuo-ku, Niigata, Niigata, 950-1197, Japan
TEL 025-281-5151
Homepage URL
Email s-denda@hosp.niigata.niigata.jp

Sponsor
Institute Niigata City General Hospital
Institute
Department

Funding Source
Organization Niigata City General Hospital
Organization
Division
Category of Funding Organization Local Government
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 15 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027211

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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