UMIN-CTR Clinical Trial

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