UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pain treatment using the Epimed Spring Guide Epidural Catheter
Title of the study (Brief title)	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	Sadahei Denda
Organization	Niigata City General Hospital
Division name	Pain Clinic Surgery
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	Sadahei Denda
Organization	Niigata City General Hospital
Division name	Pain Clinic Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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