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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025198
Receipt No. R000028924
Scientific Title Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/09

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Basic information
Public title Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain

Acronym Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain
Scientific Title Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain

Scientific Title:Acronym Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain
Region
Japan

Condition
Condition Failed back surgery syndrome, disc hernia, neck and lumbar spinal canal stenosis,and degenerative spondylosis to be resistant to conservative treatment and surgical treatment
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation the effect of adhesiolysis with Racz catheter against conventional treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Establishment of the epidural adhesiolysis for the patients with failed back surgery syndrome, lumber disc hernia, neck and lumbar spinal canal stenosis, and degenerative spondylosis to be resistant
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 We record pain score (NRS, VAS), the Japanese Orthopedics Association Back Pain Evaluation Questionnaire(JOABPQ), EQ-5D.
We record it before treatment , next day ,4 weeks,12 weeks, 24 weeks after treatment.
We record medicine, blood pressure, pulse, a few days before treatment,next day,4 weeks,12 weeks,24 weeks after treatment.
Epidurography : before treatment, next day,12 weeks after treatment.
We perform whether patients meet exclusion criteria as a screening 1-4 weeks before treatment.
We record an adverse from 1-3 days before treatment to 24 weeks after treatment,when it happenned.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with failed back surgery syndrome, disc hernia, neck and lumbar spinal canal stenosis, degenerative spondylosis to be resistant to conservative treatment and surgical treatmentand furthermore, the patients performed epidurography using contrast media,with defect the epidural space and nerve root of the pain site.
Key exclusion criteria (1)The patients during an antiplatelet drug, and anticoagulant drug (who are available for discontinuation are excluded), the patients with the bleeding tendency
(2) The patients with the mental disorder
(3) The patients with malignant disorder
(4) The patients with serious liver and renal dysfunction
(5) Is the patients of the drug irritable diathesis such as allergies with a use drug
(6) A pregnant woman or the patients with desire for pregnancy
(7)In addition, the patients who the doctor attending of this study judged as an inadequate case
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka medical college
Division name Department of anesthesiology
Zip code
Address 2-7 Daigaku-machi,Takatsuki,Osaka,JAPAN
TEL 072-683-1221
Email ane022@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Morimoto
Organization Osaka medical college
Division name Department of anesthesiology
Zip code
Address 2-7 Daigaku-machi,Takatsuki,Osaka,JAPAN
TEL 072-683-1221
Homepage URL
Email ane046@osaka-med.ac.jp

Sponsor
Institute Osaka medical college
Institute
Department

Funding Source
Organization Osaka medical college
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 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 12 Month 09 Day
Last modified on
2016 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028924

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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