UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040500
Receipt number 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 14:07:04

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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 or person

Institute

Ebetsu city hospital
department of painclinic and anesthesia

Institute

Department

Personal name



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

Value
https://center6.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