UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040500
Receipt No. R000046204
Scientific Title The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.a single center. retrospective observation study.
Date of disclosure of the study information 2020/06/07
Last modified on 2020/05/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.
Acronym The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.
Scientific Title The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.a single center.
retrospective observation study.

Scientific Title:Acronym The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.
Region
Japan

Condition
Condition Failed back surgery syndrome (adults)
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effect of percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome with or without instrumental fixation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy evaluations: Numerous rating scale of numbness and low back pain before the percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution.
Numerous rating scale of numbness and low back pain 24hours after the percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution.
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Failed back surgery syndrome without spinal cord damage.
2.Japanese males and females aged over 20 years old.
3. Indivisuals whose written informed consent has been obtained .
4. Indivisuals judged appropriate for the study by the principal.

Key exclusion criteria 1. Indivisuals with spinal cord dameged.
2. Indivisuals did not receive the percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution.
Target sample size 21

Research contact person
Name of lead principal investigator
1st name koichi
Middle name
Last name ota
Organization Ebetsu city hospital
Division name department of painclinic and anesthesia
Zip code 067-8585
Address 6wakakusa-chyou ebetsu
TEL +81113855151
Email kota64998@gmail.com

Public contact
Name of contact person
1st name koichi
Middle name
Last name ota
Organization Ebetsu city hospital
Division name department of painclinic and anesthesia
Zip code 067-8585
Address 6wakakusa-chyou ebetsu
TEL +81113825151
Homepage URL
Email kota64998@gmail.com

Sponsor
Institute Ebetsu city hospital
department of painclinic and anesthesia
Institute
Department

Funding Source
Organization Ebetsu city hospital
department of painclinic and anesthesia
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 IRB of ebetsu city hospital
Address 6wakakusa-chyou ebetsu
Tel +81113825151
Email hos-kanri@city.ebetsu.lg.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 江別市立病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 07 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
2020 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2020 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To aim the effect of percutaneous epidural lysis of adhesions and neuroplasty with isobaric solusion for 21 cases of the failed back surgery syndrome.
The percutaneous epidural lysis of adhesions and neuroplasty with isobaric solusion decreased significantly numbness and low back pain 24 hours after the treatment for the failed back surgery syndrome with or without posterior limbar interbody fusion.
The percutaneous epidural lysis of adhesions and neuroplasty with isobaric solusion is useful therapy for the failed back surgery syndrome.

Management information
Registered date
2020 Year 05 Month 23 Day
Last modified on
2020 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046204

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.